Associate Ii

3 weeks ago

Chennai, India Pfizer Full time

Functions as Regulatory support for assigned projects and the life-cycle changes; works with Project Leads/Product Leads, cross-funcational teams, local and regional regulatory colleagues, external partners (in-licensed products) and Global Health Authorities (if required) to independently frame and drive global regulatory strategies for post approval changes and Global Expansion submisions.
- May provide adequate support and guidance to the team member(s) for authoring regulatory submissions and ensure effective data presentation and quality through effective review.
- Responsible for authoring quality and timely CMC contributions for license maintenance activities such as US Annual Reports, Renewals, and other regulatory submissions under mínimal/no supervision.
- Authors key pieces of regulatory strategy and/ or submissions as delegated by the Product/Project Lead(s) (additional to assigned products), on need basis.
- Negotiates submission data requirements and deliverable dates on need basis.

Remains knowledgeable and maintains awareness about current regulations and guidance related to small molecule pharmaceuticals, Biologics and Biosimilars, interprets, assesses its impact on product development programs and communicates to necessary stakeholders.
- Drives resolution of issues, communicates issues, impact and outcomes to global regulatory management and core team.

Responsible for effective coordination and collaboration with the regional regulatory leads to ensure key submission deliverables assigned to the group are met.

Works under mínimal/no supervision and perfoms assignments using established procedures and general instruction on the process and desired outcome.

Accountable for ensuring compliance to the submission standards, procedures and policies framed by Global Regulatory Affairs.

Suggests, supports and implements system improvements to ensure regulatory compliance, to reduce cycle time and to create efficiency.
- Mentor/ guide the new joiners (Individual contributors) on technical aspects of Small Molecule Pharmaceuticals, Biologics/Biosimilars regulatory requirements as well as Pfizer systems & tools.

Preferred Experience: Minimum 1 to 3 Years of experience in Pharmaceutical Industry with major experience in Regulatory Affairs group handling new submissions and / or LCM submission to global health authorities especially USFDA, EMA and other EU authorities.

Has an understanding on global strategy and legislation that pertains to Small molecule Pharmaceuticals, Biologics and Biosimilars.

Experience in filing Sterile injectable submission is preferable.
- Preferred Attributes: Good oral and written English communication skills. Good conceptual, analytical, problem solving, and organizational skills. An assertive, take-charge, proven manager with a strong result orientation, positive “can do” attitude, and a sense of urgency to get things done. Can makes decisions to resolve moderately complex problems in standard situations. Makes decisions within guidelines, policies & procedures. Can work independently in ambiguous situations as part of a work team.
- Technical Skills: Comprehensive knowledge on Regulatory requirements for Small molecule Pharmaceuticals, Biologics and Biosimilars development and life-cycle changes for US and/or Europe and has an expertise to prepare and submit complex regulatory submissions related to Biologics and Biosimilars.

Knowledge on ICH Guidance (Q,S, E and M).

Sound understanding and functional knowledge on manufacturing / pharmaceutical sciences / the pharmaceutical industry with a clear understanding of drug development and/or commercial manufacturing of pharmaceutical products, including technical and scientific understanding of drug development with technical writing skills for small molecule pharmaceutical, Biologics/Biosimilars and /or Sterile injectable manufacturing and regulatory data requirements for global submission.

Competency in understanding and interpreting regulatory requirements and emerging regulatory landscape for small molecules pharmaceuticals, Biosimilars/ Biologics.

Ability to comprehend and summarize complex technical data.

High level of knowledge ongeneral standards, processes and policies of Pfizer/Pharmaceutical manufacturing Industry.

Work Location Assignment: On Premise

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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