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