Associate II - Regulatory CMC Strategy - Brands CMC

Pfizer

4.1

(94)

Chennai, India

Why you should apply for a job to Pfizer:

  • 4.1/5 in overall job satisfaction
  • 4.6/5 in supportive management
  • 78% say women are treated fairly and equally to men
  • 79% would recommend this company to other women
  • 81% say the CEO supports gender diversity
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • 23-25 Week Maternity Leave (Fully paid for birth parents)
  • Family building benefits include $35,000 fertility services + $25,000 adoption and surrogacy services
  • Pfizer is a founding member of Healthcare Businesswomen's Association Gender Parity Collaborative
  • #4912003

    Position summary

    tent and seeks endorsement by the GRS-CMC; Responsible for authoring and/or compiling Regulatory Strategy Documents (RSD) where needed; Responsible for authoring of CMC content in Module 1, Module 2.3, M3.2.S/P/R as agreed upon with the GRS CMC within agreed timelines.

    • Responsible for identification and communication of identified risks to the GRS CMCs and/or appropriate leadership, also proposes mitigation strategy with the support of team lead; Ensures resolution of issues and manages regulatory risks within project.

    • Reviews and applies pertinent global regulatory guidelines. Exhibits technical / functional expertise and provides strategies on regulatory requirement, negotiates with and influences the cross functional teams, colleagues and external partners to ensure regulatory data requirements are met.

    • Coordinates with the respective team for M3.2.R Ancillary documents.

    • Represents HBU GRA CMC point of view and meets with key stakeholders to resolve challenges.

    • Coordinates internal document review and sign off.

    • Utilizes Pfizer's CMC systems, i.e. GDMS, PDM, SPA, etc, as appropriate.

    • Supports Query and/or commitment management in collaboration with GRS CMCs.

    • Maintains conformance systems maintenance in support of the GRS CMCs.

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

    Regulatory Affairs

    #LI-PFE

    Why you should apply for a job to Pfizer:

  • 4.1/5 in overall job satisfaction
  • 4.6/5 in supportive management
  • 78% say women are treated fairly and equally to men
  • 79% would recommend this company to other women
  • 81% say the CEO supports gender diversity
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • 23-25 Week Maternity Leave (Fully paid for birth parents)
  • Family building benefits include $35,000 fertility services + $25,000 adoption and surrogacy services
  • Pfizer is a founding member of Healthcare Businesswomen's Association Gender Parity Collaborative