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Associate II - Reg CMC Strategy, SI LCM

Employer
Pfizer
Location
Chennai, India
Salary
Competitive
Closing date
1 Jun 2024

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Sector
Science and Pharmaceutical
Role
Associate
Contract Type
Permanent
Hours
Full Time

Job Details

Responsibility:
  • Functions as support for GRS-CMC to perform the following activities (under supervision) for Nitrosamine assessment:
    • Step 1 Assessment for Nitrosamine risk
    • Step 2 Confirmatory testing
  • Responsible for effective review and providing timely feedback to the GRL/RRL/CRL on technical documents (on a need basis).
  • Remediation Planning: Effective coordination with the GRL/RRL/CRLs, and extend support as needed towards preparation, review and finalization of Global Regulatory Strategy Documents (GRSDs).
  • Submission Execution: Author required CTD sections for filing of supplements /variations,ensuring effective data presentation and quality, as per the finalized GRSD supporting GRS CMC.
  • Support the data alignment team related to RPS
  • Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks.
  • Works under supervision.
  • Performs all assignments using established procedures and general instructions on the process.
  • Remains knowledgeable about current regulations / guidelines and correlates in the assigned projects.
QUALIFICATIONS / SKILLS:
  • Preferred Education:
Bachelors or Master in Science / Pharmacy

Preferred Experience:

Minimum 3 Years in working independently in the Regulatory Affairs function in a reputed Pharmaceutical Organization with major experience in handling post approval changes to health authorities.

Preferred Attributes:

Good English communication skills (both verbal and written). Good interpersonal and negotiation skills.

Good conceptual and reasoning skills. Attention to details.

Technical Skills:

o Regulatory requirements of post approval changes for various global regulatory agencies especially

USFDA and EMA & other EU health Authorities.

o Sound understanding ICH Quality Guidelines.

o Sterile injectable manufacturing and regulatory data requirements for submission.

o Knowledge on general standards, processes and policies of Pharmaceutical Industry.

Work Location Assignment: Flexible

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs

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