13 Jobs für Drug Registration Manager
Stellenangebote Drug Registration Manager Jobs
Neu Job vor 4 Std. bei Jobleads gefunden
Führungs-/ Leitungspositionen
[. .. ] with the goal to address the needs of patients with cancer. Nuvalent is an exciting earlystage company, bringing together experienced scientists and industry veterans with a proven [...]
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[...] track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Senior Director, Payer Reimbursement, the Associate Director, Pricing Contracting Operations plays a critical role in shaping and executing the companys pricing and contracting strategies to optimize access to Nuvalents product portfolio, as well as playing a key part [. .. ] pricing and contract execution. Responsibilities: Strategic Pricing Operations Assist in the development and lead implementation and optimization of pricing strategies for inline and pipeline oncology products Serve as the operational manager of the Pricing Committee, including: Managing agenda, preparation and facilitating meetings Aligning stakeholders and driving strategic input Documenting decisions and actions Contracting Execution Management Design and manage contracting strategies across key segments: Commercial, Medicare, GPOs, Medicaid, 340B, VA, Payers/ PBMs, and IDNs Manage daytoday contract execution and issue resolution Submit [. .. ] Solicitation and Interim Agreement Collaborate with Finance and Vendor to complete Public Law 102585 submission and documentation Monitor the Tracking Customer and initiate a change if required Complete the initial registration and annual renewals of SAM. gov Competencies: Demonstrated passion for improving patient access and outcomes. Problem Solving: Proactive approach to resolving complex access issues. Analytical Skills: Ability to interpret coverage trends payer policies to identify barriers and implement solutionoriented strategies to optimize patient access. Business Acumen: Indepth understanding of prior [. .. ]
Job vor 3 Tagen bei Jobleads gefunden
[. .. ] and willingness to travel as needed. The Opportunity The ideal candidate for this role is experienced in working closely with Contract Development and Manufacturing Organizations (CDMOs) that [...]
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[...] provide small molecule drug substance and drug product services to the pharmaceutical industry. Working closely with Praxis CDMO network, the individual will use his or her knowledge of analytical method development, qualification, validation, and testing to support analytical projects across the portfolio. Strong collaboration with Drug Substance/ Drug Product scientists, engineers, Quality and manufacturing [. .. ] drug substances and drug products. Involvement in reference standard management and stability oversight. Experience with CMC development and support across all phases of drug development from initial regulatory filings through registration, validation and launch preferred. Experience in support of late stage/ commercial products including product monitoring, improvement and issue resolution preferred. Demonstrated success in building and maintaining productive partnerships with CDMO partners and associated service providers to ensure the companys objectives are achieved. Fluid and conversant with GMP and quality control. [. .. ]
Neu Job vor 4 Std. bei Jobleads gefunden
• Zug
Project
Manager, CMC Regulatory Affairs Responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products. Key Responsibilities Responsible for the [...]
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[...] global CMC regulatory activities for assigned projects and responds readily to changing events and priorities. Responsible for CMC strategy development, with [. .. ] MAA) and early lifecycle management activities in accordance with the applicable regulatory scientific standards. Understands, interprets and will sometimes advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of medicinal products, to expedite the submission, review and approval of global CMC applications. Ensures all appropriate CMC regulatory aspects for clinical trials/ product release are in place, to avoid clinical holds and/or to ensure continuity of market supply. Ensures information submitted in clinical/ marketing applications meets [. .. ] experience with direct involvement in regulatory submission preparation across all stages of development through to early life cycle submissions. Degree in life sciences or related scientific discipline. Sound knowledge of drug development, manufacturing processes and supply chain and may have a specialized area of expertise. Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development. Good timemanagement skills with the ability to effectively plan, prioritise and coordinate multiple [. .. ]
Neu Job vor 4 Std. bei Jobleads gefunden
Location This position may be performed remotely with travel to the Boston area as needed. Position Summary The Quality Operations
Manager, CMC is responsible for a variety of operational activities [...]
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[...] pertaining to assuring product quality and compliance to the manufacture, testing, control, validation, and release of drug substance and drug product for commercial and clinical distribution. They serve as the quality expert for the Praxis pipeline of neurological disease product programs and are responsible for making strategic quality decisions throughout the product lifecycle end-to-end. The incumbent will work with the CMC team executing clinical-stage [. .. ] maintenance, and review of clinical and commercial Quality Agreements Act as Product Quality Lead in CMC, Program, and CSP team meetings to provide strategic direction and leadership to product development, registration, and approvals. Owns the APR/ PQR, coordinating cross functionally to ensure regulatory requirements are met and that actions are managed to conclusion. Direct the disposition (release/ reject) activities interfacing with a QP where applicable. Ensure cohesive collaboration across CSPs for timely review of manufacturing records Ensure robust processes are implemented [. .. ]
Job vor 3 Tagen bei Jobleads gefunden
Project Manager, CMC Regulatory Affairs
Site Name: Warsaw, Baar Onyx, Poznan Grunwaldzka, UK-Hertfordshire-Ware RD, UK London New Oxford Street, Upper Providence, USA-Massachusetts-Waltham, Zug House Project
Manager, CMC Regulatory Affairs Responsible for the CMC regulatory activities [...]
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[...] in the investigational, late phase development and/or early commercial lifecycle management of GSK products. Key Responsibilities include: Responsible for the global CMC regulatory activities for assigned projects and responds readily to changing events and priorities. Responsible for CMC strategy development, [. .. ] BLA/ MAA) and early lifecycle management activities in accordance with applicable regulatory scientific standards. Understands, interprets and will sometimes advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of medicinal products, to expedite the submission, review and approval of global CMC applications. Ensures all appropriate CMC regulatory aspects for clinical trials/ product release are in place, to avoid clinical holds and/or to ensure continuity of market supply. Ensures information submitted in clinical/ marketing applications meets [. .. ] experience with direct involvement in regulatory submission preparation across all stages of development through to early life cycle submissions. Degree in life sciences or related scientific discipline. Sound knowledge of drug development, manufacturing processes and supply chain and may have a specialized area of expertise. Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development. Good time management skills with the ability to effectively plan, prioritise and coordinate [. .. ]
Job vor 4 Tagen bei Jobleads gefunden
• Lausanne, Waadt
Regulatory affair
manager Approach People Recruitment Lausanne, State, Switzerland Job Description: As a Regulatory Affairs Manager, you will be responsible for ensuring compliance with regulatory requirements related to the development, [...]
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[...] approval, and marketing of pharmaceutical, medical device, or other healthcare products. You will work closely with cross-functional teams to navigate the complex regulatory landscape and to ensure that products meet all applicable regulations and standards. Responsibilities Develop and implement regulatory strategies for product development, registration, and commercialization. Prepare and submit regulatory submissions, including Investigational New Drug (IND) , New Drug Application (NDA) , 510 (k) , Pre-Market Approval (PMA) , or other regulatory filings, as required. Liaise with regulatory agencies, such as the FDA, EMA, or other regulatory authorities, to facilitate the review and approval process for new products or product changes. Provide regulatory guidance [. .. ]
Job vor 4 Tagen bei Jobleads gefunden
• Basel, Basel- Stadt
Senior Technical Regulatory Affairs
Manager Location: Basel, BS, CH About Idorsia Pharmaceuticals Ltd Headquartered near Basel, Switzerland a European biotech hub Idorsia has a highly experienced team of dedicated [...]
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[...] professionals covering all disciplines from bench to bedside; QUVIVIQ (TM) (daridorexant) , a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. We are looking for a Senior Technical Regulatory Affairs Manager to join our team Job Responsibilities Write, update, and keep track of the Module 2 (Quality Overall Summary) and Module 3 (Quality) of CTDs [. .. ] operational and strategic perspective. Organize reviews (CMC team, Management, DRA, management committee) , assess the comments and consolidate technical documents for global regulatory submissions. Ensure consistency between raw data and registration documents contents. Prepare and track Pre-and Post-approval synopsis. Store technical regulatory documents within the relevant document management systems using up-to-date dictionaries and metadata. Candidates Requirements University degree (MSc, Ph D) in Pharmacy (Pharm D) , Chemistry or biology, or alternative technical/ science university degree. Experience of at [. .. ]
Job vor 4 Tagen bei Jobleads gefunden
• Allschwil, Basel- Landschaft
Job Description The
Manager, Global Labeling Operations will lead and oversee labeling implementation and lifecycle activities for Johnson Johnson Innovative Medicine products. This hybrid role is based in Allschwil, [...]
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[...] Switzerland. Responsibilities Lead labeling implementation activities under Global Labeling Operations: Provide regulatory guidance on U. S. packaging text for labeling mockups and production artwork. Request, review, and approve mockups and production artwork in the electronic artwork management system. Manage labeling implementation inputs and deliverables for registration sample packs, Sa MD, and other non-U. S. labeling in scope of GL. Track implementation of artwork for safety changes and other labeling issued. Provide input into change controls related to labeling implementation or delisting activities. Actively participate in project teams for launches, lifecycle changes, and supplychainled labeling initiatives, partnering [. .. ] data in departmental labeling and project trackers, and update labeling history documents related to product artwork changes. Obtain and prepare labeling implementation input for U. S. Annual Reports. Assign National Drug Code (NDC) numbers and maintain the NDC log for J J Innovative Medicine and Patriot Pharmaceutical U. S. -marketed products; support Establishment Registrations, Drug Listing, and Structured Product Labeling (SPL) . Support the Legal Department with litigation efforts related to GLmanaged labeling as needed. Provide feedback on U. S. Product [. .. ]
Job gestern bei Neuvoo gefunden
Fresenius Medical Care
• Bad Homburg, Hesse
Work-Life-Balance
[. .. ] on nutrition QAI results and participates in the interdisciplinary QAI program. Collaborates and coordinates with team members in provision of Pre-ESRD education as appropriate. When appropriate, works [...]
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[...] with Case Manager to coordinate plan of care for patient education and identifies candidates to refer to physician for nutritional supplements, as per disease management agreements. Reviews nutrition related lab results: Counsels patient and/or caregiver and formulates appropriate action. Recommends treatment changes to the interdisciplinary team as appropriate. Communicates with physician and/[. .. ] plan meetings, and others as applicable. Consults with FMS Corporate Dietitian regarding nutrition concerns as needed. Maintains and improves knowledge and skills for a competent and innovative practice. Maintains dietetic registration and continuing education hours as specified by American Dietetic Association and state licensure regulations where applicable. Collaborates with interdisciplinary team, ensuring that all work areas are safe and clean. Other nutrition management duties as assigned. Performs other related duties as assigned. PHYSICAL DEMANDS AND WORKING CONDITIONS : The physical demands [. .. ] making. Able to perform responsibilities with minimum supervision. Basic computer skills required. EO/ AA Employer: Minorities/ Females/ Veterans/ Disability/ Sexual Orientation/ Gender Identity Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws. Career with a purpose We offeran opportunity to create and deliver treatments that save and change lives for the better. Well support your ongoingdevelopment. And youll be part of a dedicated team of people who inspire each other to create the [. .. ]
Job vor 11 Tagen bei Job-Consult gefunden
Recruiter Vitaly Pryadka
• Lorraine/ (Frankreich)
[. .. ] are looking for pharmacists the current team is composed of pharmacists the job profiles we are looking for are oriented on the following sectors pharmacotechnics clinical parmacy [...]
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[...] computerization of the drug circuit sterilization quality assurance manager other requirements pharmacist meeting the requirements of the decree of january concerning the conditions of exercise in pui registration to the list of aptitude of hospital pharmacists rmunration monthly salary between and net month requirements expectations be a national of the european union or a national of a country with which belgium has an exchange agreement for workers have a degree in general medicine and hospital pharmacy from a [. .. ]
Job vor 11 Tagen bei Job-Consult gefunden
PhD- Jobs. NET
Pharmacist
• France/ (Frankreich)
[. .. ] are looking for pharmacists the current team is composed of pharmacists the job profiles we are looking for are oriented on the following sectors pharmacotechnics clinical pharmacy [...]
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[...] computerisation of the drug circuit sterilisation quality assurance manager other requirements pharmacist meeting the requirements of the decree of january concerning the conditions of exercise in pui registration to the list of aptitude of hospital pharmacists remuneration and benefits monthly salary between and net month requirements and expectations be a national of the european union or a national of a country with which belgium has an exchange agreement for workers have a degree in general medicine and hospital [. .. ]
Job am 29.03.2026 bei Neuvoo gefunden
PAION Pharma GmbH
Production Manager Pharma for Commercial API and Drug Product (m/f/d)
• Aachen, North Rhine- Westphalia
Homeoffice möglich
Work-Life-Balance
Your tasks We are looking for a Production
Manager Pharma (m/f/d) to join our team in Aachen to ensure that the manufacturing of our APIs and
drug products [...]
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[...] meets our commercial requirements from the manufacturing/ production perspective. Responsibilities/ Main Tasks Become the Subject Matter Expert (SME) for all aspects of PAIONs API and Drug Product manufacturing activities. As the SME manage the interaction with PAIONs CMOs for the manufacture of our APIs and Drug Products Review manufacturing [. .. ] production related topics where applicable, including the organization and support of manufacturing process transfer programs In cooperation with out regulatory team, provide technical support with the writing and maintenance of registration documentation Provision of subject matter expertise to support audits of manufacturing facilities in accordance with GMP, current guidelines and internal procedures. Your profile Postgraduate/ graduate in Pharmacy, Pharmaceutical Sciences, Chemistry or Life Science At least 5 years in pharmaceutical or biotechnology industry; preferably with experience in areas such as manufacturing [. .. ]
Job am 03.02.2026 bei Neuvoo gefunden
Neuraxpharm
Head of Regulatory Affairs (w/m/d) DACH
• Langenfeld, North Rhine- Westphalia
Führungs-/ Leitungspositionen
30+ Urlaubstage Work-Life-Balance
[. .. ] Profil: Ausbildung Masterabschluss in Pharmazie, Chemie oder Biologie Wünschenswert: zusätzlicher Master in Regulatory Affairs Fließende Deutsch- und Englischkenntnisse (idealerweise muttersprachliches Niveau in Deutsch) Berufserfahrung 710 Jahre Berufserfahrung [...]
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[...] als Regulatory Affairs Manager in der pharmazeutischen Industrie Mindestens 2 Jahre Führungserfahrung in der Leitung eines RA Teams Sehr gute Kenntnisse der regulatorischen Prozesse und der nationalen Arzneimittelgesetzgebung in Deutschland und Österreich Sicherer Umgang mit regulatorischen Datenbanken und Systemen (z. B. RIM) sowie e CTD Software Versierter Umgang mit MS Office (Excel, Power Point, Word) [. .. ] strategies to optimize costs and timelines in regulatory and labeling processes. Provide regulatory expertise and strategic decision-making for key RA activities. Manage, review, and submit all documentation required for registration dossiers to the relevant health authorities, ensuring timely and budget-compliant execution. Communicate, coordinate, and negotiate with health authorities on ongoing regulatory projects, processes, and changes to ensure market presence. Allocate RA resources and monitor the progress of all ongoing projects to ensure timely implementation. Approve variation and renewal applications [. .. ] 710 years of experience as a Regulatory Affairs Manager in the pharmaceutical industry At least 2 years of experience leading an RA team Strong knowledge of regulatory processes and national drug legislation in Germany and Austria Confident use of regulatory databases and systems (e. g. , RIM) and e CTD software Proficient in MS Office (Excel, Power Point, Word) Personal Competencies Analytical thinking and structured decision-making Solution-oriented and proactive working style Agility and high adaptability ABOUT US Neuraxpharm is a [. .. ]
Häufig gestellte Fragen
Wieviel verdient man als Drug Registration Manager pro Jahr?
Als Drug Registration Manager verdient man zwischen EUR 55.000,- bis EUR 85.000,- im Jahr.
Wieviele offene Stellenangebote gibt es für Drug Registration Manager Jobs bei unserer Jobsuche?
Aktuell gibt es auf JobRobot 13 offene Stellenanzeigen für Drug Registration Manager Jobs.
Wieviele Unternehmen suchen nach Bewerbern für Drug Registration Manager Jobs?
Aktuell suchen 6 Unternehmen nach Bewerbern für Drug Registration Manager Jobs.
Welche Unternehmen suchen nach Bewerbern für Drug Registration Manager Stellenangebote?
Aktuell suchen zum Beispiel folgende Unternehmen nach Bewerbern für Drug Registration Manager Stellenangebote:
- Fresenius Medical Care (1 Job)
- Recruiter Vitaly Pryadka (1 Job)
- PhD- Jobs. NET (1 Job)
- PAION Pharma GmbH (1 Job)
- Neuraxpharm (1 Job)
In welchen Bundesländern werden die meisten Drug Registration Manager Jobs angeboten?
Die meisten Stellenanzeigen für Drug Registration Manager Jobs werden derzeit in Nordrhein-Westfalen (2 Jobs), Saarland (1 Jobs) und Sachsen (1 Jobs) angeboten.
Zu welchem Berufsfeld gehören Drug Registration Manager Jobs?
Drug Registration Manager Jobs gehören zum Berufsfeld Regulatory Affairs & Management.
