Pfizer Released Job Openings On 21/09/2022. 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) Graduates with 08+ years of experience For Manager – Reg CMC Strategy, Devices Position.Complete Details for the Manager – Reg CMC Strategy, Devices as follows.
Important Details :
- Location : Chennai
- No of Vacancies:NA
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application: 21/09/2022
- 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
Job Description/Skills Required
The purpose of this role is to lead regulatory device strategists to asses/assist Global Regulatory Leads (GRLs) to define the global submission strategy for the Devices CMC team within GRA-India Strategy. He/she needs to provide strategic guidance to assigned projects through a team of regulatory strategists responsible for authoring regulatory submissions and supporting maintenance/compliance activities for devices and combination products; modelling strong mentorship and project management techniques to the Devices CMC team assuring a global focus of goals, strategies and plans. As a lead he/she is directly accountable for ensuring regulatory deliverables of the assigned products in accordance with time, cost and quality expectations for all projects in portfolio through collaborative working relationships with global CMC leads, GRLs and other stake holders (PGS, BTxPS, PTxPS, and external partners). The colleague is responsible for mentoring junior colleagues as and when required and contribute to overall management, alignment and process improvement and drive the appropriate culture and behaviors through the organization in accordance to the Pfizer values.
The major duties and responsibilities are as below:
Functions as senior member for the Devices programs and life-cycle management (LCM) regulatory responsibilities for Devices CMC team, GRA-India Strategy Group. The responsibilities include but not limited to,
- 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.
- Contribute to GCMC projects, initiatives & actions along with prioritizing assigned workload appropriately.
- Mentors team(s) 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.