Pfizer Associate Role For Pharma – Apply Online
Pfizer Associate Role For Pharma – Apply Online. Interested and eligible applicants can check out all of the details on the same below:
Associate-II Reg CMC
Locations: India – Chennai
Time Type: Full time
Posted on: Posted today
Job requisition ID: 4906633
Functions as Regulatory support for biosimilars and biologics development projects and life-cycle changes. Works with project leads/product leads, cross-functional 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 submissions.
Manages the preparation and maintenance of core dossiers for original applications and subsequent changes (moderate technical and 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 team members to understand systems and processes.
May provide adequate support and guidance to team members 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 submissions (Brazil), and BPDR, under minimal or no supervision.Authors key pieces of regulatory strategy and submissions as delegated by the product/project leads (additional to assigned products), as needed.
Advises biologics and biosimilars programs on regulatory requirements, coordinates and presents regulatory data needs, and negotiates with and influences management, cross-functional teams, and external partners to ensure regulatory data requirements/compliance (site registration/data review/support during HA inspections, if needed) and deliverable dates are met.
Negotiates submission data requirements and deliverable dates as needed. Remains knowledgeable and maintains awareness about current regulations and guidance related to biologics and biosimilars, interprets and 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 regional regulatory leads to ensure key submission deliverables assigned to the group are met. Works under minimal or no supervision and performs assignments using established procedures and general instruction on the process and desired outcome.
Accountable for ensuring compliance with the submission standards, procedures, and policies framed by global regulatory sciences. Suggests, supports, and implements system improvements to ensure regulatory compliance, reduce cycle time, and create efficiency. Mentors and guides new joiners on technical aspects of biologics/biosimilars regulatory requirements as well as Pfizer systems and tools.
- Preferred Education: Bachelor’s or Master’s (Biotechnology/Pharmacy/Science) or Ph.D. (Biotechnology/Biological Sciences).
- Preferred Experience: Minimum 3 years of experience in the pharmaceutical industry with significant experience in regulatory sciences, handling new submissions and/or LCM submission to global health authorities, especially USFDA, EMA, and other EU authorities. Understanding global strategy and legislation pertaining to biologics and biosimilars. Experience in filing sterile injectable submissions is preferable.
- Preferred Attributes: Good oral and written English communication skills. Strong conceptual, analytical, problem-solving, and organizational skills. Assertive, take-charge approach with a positive “can do” attitude and a sense of urgency. Ability to make decisions to resolve moderately complex problems in standard situations within guidelines, policies, and procedures. Ability to work independently in ambiguous situations as part of a work team.
- Technical Skills: Comprehensive knowledge of regulatory requirements for biologics and biosimilars development and life-cycle changes for US and/or Europe. Expertise in preparing and submitting complex regulatory submissions related to biologics and biosimilars. Knowledge of ICH guidance (Q, S, E, and M). Sound understanding and functional knowledge of manufacturing/pharmaceutical sciences/pharmaceutical industry with a clear understanding of drug development and/or commercial manufacturing of pharmaceutical products. Technical and scientific understanding of drug development with technical writing skills for biologics/biosimilars and/or sterile injectable manufacturing and regulatory data requirements for global submissions. 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 guide teams to apply them in their respective assigned projects. High level of knowledge of 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.
Keywords: Pfizer, pharmaceutical company, biosimilars, biologics, regulatory sciences, global health authorities, USFDA, EMA, technical skills, regulatory submissions, drug development. Pfizer Associate Role For Pharma – Apply Online. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
