Pfizer Released Job Openings On 15/12/2022. Pfizer Inc. is an American multinational pharmaceutical corporation. Pfizer is one of the world’s largest pharmaceutical companies, and was ranked 64th on the 2020 Fortune 500 list of the largest U.S. corporations by total revenue, at $47.644 billion as of December 31, 2020 .
Pfizer Recruiting Bachelors or Master (Biotechnology/ Pharmacy/ Science/Engineering) or Ph. D (Biotechnology/Biological Sciences/Engineering) with 04+ years of experience For Associate Manager II – Reg CMC Strategy, Devices Position.
Important Details :
- Location : Chennai
- No of Vacancies:NA
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application: 15/12/2022
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
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Job Description/Skills Required
- Maintenance of the expansive combination of CMC product information, market registration details, component level dossier content and compliance of an integrated regulatory change management process to provide a comprehensive and compliant view of the CMC registered details of all products in all markets, in support of Global Devices Team.
- Assuring product compliance through timely and accurate maintenance of CMC submission documentation and product knowledge in Regulatory systems in collaboration with Global Devices.
- Manages the preparation and maintenance of core dossiers for original applications and subsequent changes (moderate technical & regulatory complexity); coordinates Query Responses to deficiency letters from Health Authorities, with the assistance of local and regional regulatory colleagues.
- Contribute to GCMC projects, initiatives & actions along with prioritizing assigned workload appropriately.
- Authors key pieces of regulatory strategy and/ or submissions as delegated by the Product/Project Lead(s) (additional to assigned products), on need basis
- Occasionally mentors team of regulatory strategists responsible for device related submissions; coordinates and presents regulatory data needs and negotiates with and/or influences management, cross functional teams and external partners to ensure regulatory data requirement and the deliverables are met.
- Serving as CMC representative on a core project(s) demonstrating ability to manage project activities, assess regulatory risks & development plans to develop global regulatory strategies for programs in accordance with regulatory, scientific & technical criteria. Manage regulatory issues, maintain submission information in relevant GCMC systems, tracks regulatory commitments & timelines for specific projects/products/markets with minimal supervision.
- Exhibits business acumen and ensures thorough and timely assessment of change controls in regulatory perspective for the Product Change Forms (PCFs) assigned to the team; influences and provides right direction/ regulatory solutions to various stakeholders on change control matters including complex changes and for changes where the regulations are ambiguous.
- Provides adequate review support and guidance to the team during strategy development and for authoring regulatory submissions/compliance activities to ensure effective data presentation and quality.
- Remains knowledgeable and maintains awareness about current regulations and guidance related to Devices and combination products, interprets, assesses impact on development & LCM programs and communicates to necessary functions and leadership.
- Responsibe for ensuring all regulatory activities for assigned products are executed effectively and efficiently in compliance with external regulatory requirements and internal submission standards, quality procedures and policies framed by Global Regulatory Affairs.
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