Manager - Visakhapatnam/vizag - Pfizer Limited
- Pfizer
- 6 - 8 years
- Visakhapatnam
- 3 years ago
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Job Description
- As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services.
- Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies.
- Responsible for preparation and/or provide review support and guidance to product owners on technical and regulatory knowledge towards preparation of Site transfer Global regulatory strategy document (GRSD), supplements/variations and other regulatory documents
- Functions as product owner for site transfer submissions for assigned products, working with cross functional site teams and corporate regulatory team to ensure preparation of quality global regulatory strategy document and supplements / variations.
- Provides guidance and support to Junior Product Owners in the preparation of quality global regulatory strategy document and supplements.
- Responsible for effective co-ordination with the cross functional teams at site and corporate for the review and finalization of supplements to ensure effective data presentation and quality
- Responsible for effective review and providing timely feedback to the teams on technical documents related to transfer (Technology transfer protocols), batch documents related to submission (batch records, Exhibit batch and stability protocol, etc.,)
- Provides regulatory support for Change assessment related to submissions from Vizag site
- Collaborates with and ensures adequate support to the regional team to ensure completion of assigned shared task or goal.
- Identifies , assesses regulatory risks associated with assigned projects and timely communication of the issues, its impact to global regulatory management core team and drives resolution of issues
- Drives resolution of issues. Communicates issues, impact and outcomes to global regulatory management, team lead and core team.
- Remains knowledgeable about current regulations and guidance, interprets and implements in the assigned projects
- Responsible for ensuring compliance to Company s submission standards, policies and procedures.
Qualifications
Preferred Education:
- Bachelors or Master in Science / Pharmacy
Preferred Experience:
- Minimum 10 Years in leading independently or a team in the Regulatory Affairs function in a reputed pharmaceutical organization with major experience in handling new submissions / post approval changes to health authorities especially USFDA, EMA and other EU authorities. Experience in handling site transfer submissions is preferable.
Preferred Attributes:
- Good oral and written English communication skills.
- Good conceptual, analytical, problem solving, and organizational skills
- Well-organized and accustomed to maintaining excellent records
- Good knowledge of Microsoft Office tools
Technical Skills:
- Regulatory requirements for handling Technology Transfer activities and submission of supplements/variation to various global regulatory agencies especially USFDA and preferably EMA other EU health Authorities, Health Canada and TGA.
- ICH Quality Guidances
- Sterile injectable manufacturing and regulatory data requirements for submission.
- Good level of knowledge on general standards, processes and policies o f Pharmaceutical manufacturing Industry.
Job Classification
Industry: Construction, Engineering, Cement, MetalsFunctional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology,
Role Category: Drug Regulatory Affairs/Documentation
Role: Drug Regulatory Affairs/Documentation
Employement Type: Full time
Education
Under Graduation: Any Graduate in Any SpecializationPost Graduation: Any Postgraduate in Any Specialization
Doctorate: Doctorate Not Required, Any Doctorate in Any Specialization
Contact Details:
Company: PfizerLocation(s): Visakhapatnam
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Keyskills: USFDA Pharma Analytical Pharmacy MS Office tools Manager Technology Management Regulatory affairs Operations Technical documentation
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Pfizer
Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We re looking for new talent to join our global community, to unearth new innovative therapies that make the world a he...
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