Functions as Regulatory support for Biosimilars and Biologics development 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.
Manages the preparation and maintenance of core dossiers for original applications and subsequent changes (moderate technical & regulatory complexity); coordinates Quality Query Responses to deficiency letters from Health Authorities, with the assistance of local and regional regulatory colleagues.
Functions as an individual or through project teams, utilizing technical or subject matter expertise to achieve desired results.
Supports and guides new members of the team to understand systems and processes.
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, APRR, YBPR, In-house submission (Brazil) and BPDR , under minimal/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.
Advises Biologics and Biosimilars programs on regulatory requirement, coordinates and presents regulatory data needs and negotiates with and influences management, cross functional teams and external partners to ensure regulatory data requirement/compliance (site registration/data review/support during HA inspections, if needed) and the deliverable dates are met.
Negotiates submission data requirements and deliverable dates on need basis.
Remains knowledgeable and maintains awareness about current regulations and guidance related to 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 minimal/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 Sciences. 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 Biologics/Biosimilars regulatory requirements as well as Pfizer systems & tools.
Preferred Education:
Bachelors or Master (Biotechnology/ Pharmacy/ Science) or Ph. D (Biotechnology/Biological Sciences)
Preferred Experience:
Minimum 4-7 Years of experience in Pharmaceutical Industry with major experience in Regulatory Sciences 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 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 Biologics & Biosmilars 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 understandingof drug development with technical writing skills for 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 Biosimilars/ Biologics.
Ability to comprehend and summarize complex technical data.
Ability to interpret global / regional CMC regulatory policies and requirements and guides the teams to apply in their respective assigned projects.
High level of knowledge on general standards, processes and policies of Pfizer/Pharmaceutical manufacturing 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
