Associate II –Reg CMC Strategy Functions as a CMC strategist for the development of CMC regulatory strategies, submissions and compliance activities for commercial pharmaceutical products supporting HBU’s Business. Work is periodically reviewed by Team Lead. Provides and drives strategic and operational global CMC regulatory direction and documentation for assigned projects/products covering post approval activities. Prepares the CMC information for submission to global regulatory agencies, generates and drives CMC strategies, assesses risks and develops contingency/mitigation plans. Acts as the global CMC representative within cross-functional project teams, involving the interpretation of regulations and guidelines and the assessment of global implications for strategic CMC decisions. Primary accountable for assigned CMC products, managing daily delivery of regulatory and strategic activities, including post-approval changes and compliance activities. May represent CMC during interactions with internal partners either directly or in conjunction with Team Lead. Resolve issues and manage regulatory risks within project teams. Makes decisions to resolve moderate problems in standard situations as per the guidance and policies and escalates complex issues / risks to appropriate leadership. Ensure compliance to Pfizer's training activities (e.g. functional, compliance-related, HR policies) & individual development plans, participate in cross-disciplinary forums & learning opportunities, demonstrating & modeling adherence to all Pfizer behaviors & values, embracing & complying with Principles of Integrity. Utilize Pfizer’s CMC systems, i.e. GDMS, PDM, SPA, Rosetta, PEARL, etc., as appropriate. Work Location Assignment: Hybrid Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers . Regulatory Affairs Experience Level Mid Level
Other Details
It is a Full Time Legal job for candidates with 2 - 6+ years Experience.
More about this Associate - CMC Regulatory Strategy job
What are the eligibility criteria for this Associate - CMC Regulatory Strategy job?
Ans : Candidates should have All Education levels with 2-7 years of experience for this Associate - CMC Regulatory Strategy job offered by Pfizer Limited in Melmaruvathur, Chennai.
What salary is offered for this Associate - CMC Regulatory Strategy job?
Ans : Salary details will be shared during the hiring process.
What shift and timings does this job follow?
Ans : This Associate - CMC Regulatory Strategy job follows a Day shift.
Do you need to visit the office for this job?
Ans : Yes, candidates need to visit the office and work from the location in Melmaruvathur, Chennai.
How many openings are available for this position?
Ans : There is 1 opening available for this position.
Is this job open for all genders?
Ans : Yes, this Associate - CMC Regulatory Strategy job is open for both male and female candidates.
Where is this job located?
Ans : This Associate - CMC Regulatory Strategy job is located in Melmaruvathur, Chennai.
Why should you apply for this Associate - CMC Regulatory Strategy job?
Ans : The employer has not disclosed the salary for this role, but it is a Full Time opportunity with 1 opening available.
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Pfizer Limited
Melmaruvathur, Chennai
2 - 6+ years Experience in Legal
Full Time
