Associate Ii - Reg Cmc Strategy, Si Pipeline
- Pfizer
- 2 - 6 years
- Chennai
- 1 month ago
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Job Description
Functions as a Global Regulatory Lead for the assigned, low to moderately complex products, and/or supports Global Regulatory Lead.
Responsible for/supports developing global regulatory strategies, preparing and submitting the marketing authorization dossier for drug products, by self or under guidance.
Responsible for/supports timely response to deficiencies related to marketing authorization
Supports cross-functional teams in activities related to commercial launch.
Responsible for effective coordination with the cross functional teams, site and Global RA teams for the review and finalization of marketing authorization/deficiency responses, for global markets, to ensure effective data presentation and quality.
Responsible for effective review and providing timely feedback to the cross-functional teams on technical documents related to submission (batch records, validation summaries, stability protocol/data, risk assessment reports etc. , )
Provides regulatory assessment and supports Change Control Assessment, by self or under guidance.
Ensures commitments (module 2-5) made to health authorities are entered into tracking systems and are tracked to closure, as appropriate.
Provide regulatory support for the assigned products, participates and provides inputs in technical reviews and Change Control reviews as assigned.
Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team and/or escalates to leadership team to quickly mitigate the risks, under guidance or self
Drives resolution of issues, by self or guidance. 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. Qualification and Education: M. Pharma (or other relevant science degree) with 2 to 6 Years of experience in Regulatory Affairs.
Work Location Assignment: On Premise
Responsible for/supports developing global regulatory strategies, preparing and submitting the marketing authorization dossier for drug products, by self or under guidance.
Responsible for/supports timely response to deficiencies related to marketing authorization
Supports cross-functional teams in activities related to commercial launch.
Responsible for effective coordination with the cross functional teams, site and Global RA teams for the review and finalization of marketing authorization/deficiency responses, for global markets, to ensure effective data presentation and quality.
Responsible for effective review and providing timely feedback to the cross-functional teams on technical documents related to submission (batch records, validation summaries, stability protocol/data, risk assessment reports etc. , )
Provides regulatory assessment and supports Change Control Assessment, by self or under guidance.
Ensures commitments (module 2-5) made to health authorities are entered into tracking systems and are tracked to closure, as appropriate.
Provide regulatory support for the assigned products, participates and provides inputs in technical reviews and Change Control reviews as assigned.
Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team and/or escalates to leadership team to quickly mitigate the risks, under guidance or self
Drives resolution of issues, by self or guidance. 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. Qualification and Education: M. Pharma (or other relevant science degree) with 2 to 6 Years of experience in Regulatory Affairs.
Work Location Assignment: On Premise
Regulatory Affairs
#LI-PFE
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area: Pharmaceutical & Life Sciences
Role Category: Pharmaceutical & Biotechnology
Role: Research Associate / Engineer
Employement Type: Full time
Contact Details:
Company: PfizerLocation(s): Chennai
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Keyskills: Tehnial doumentation Pharma Risk assessment CMC Compliane Management Regulatory affairs Assoiate II
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