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
Who is eligible to apply for this Associate - CMC Regulatory Strategy job at Pfizer Limited?
Ans : Candidates should have All Education levels for this Associate - CMC Regulatory Strategy job offered by Pfizer Limited.
How much can you earn in this position?
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 Vellanur, Chennai.
How many vacancies are there for this Associate - CMC Regulatory Strategy job?
Ans : There is 1 vacancy for this Associate - CMC Regulatory Strategy role.
Is this job open for all genders?
Ans : Yes, this Associate - CMC Regulatory Strategy job is open for both male and female candidates.
What is the job location for this position?
Ans : The job location for this Associate - CMC Regulatory Strategy position is Vellanur, Chennai.
What makes this Associate - CMC Regulatory Strategy job a good opportunity?
Ans : The employer has not disclosed the salary for this role, but it is a Full Time opportunity with 1 opening.
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Pfizer Limited
Vellanur, Chennai
2 - 6+ years Experience in Legal
Full Time
