Regulatory Sciences Expert

2 weeks ago


Chennai, Tamil Nadu, India Lifelancer Full time
About the Role

In this exciting opportunity, you will be part of the Global Regulatory Sciences team at Pfizer, driving the industry forward and making a positive difference. As an expert in Regulatory Sciences, you will assist CMC Global Regulatory Strategist - CMC (GRS-CMC) and collaborate with Cross Functional Teams to prepare and submit CMC submission packages as per defined timelines.

Key Responsibilities
  • You will manage your time and professional development, be accountable for your results, and prioritize workflows.
  • Assist CMC strategist in day-to-day regulatory activities associated with assigned activities under the Team Lead guidance and supervision.
  • Assist in authoring and/or compilation of CMC submission package under the guidance from Team Lead and CMC GRL as appropriate and within agreed timelines.
  • Update impacted dossier components as needed.
  • Escalate delays in timelines and flag identified risks to the CMC GRL and/or appropriate leadership.
  • Coordinate internal document review and sign off.
  • Utilize Pfizer's CMC systems, i.e., GDMS, PDM, SPA, etc., as appropriate.
  • Ensure compliance to Pfizer internal procedures and training SOPs (PLA).
RequirementsMust-Have Skills
  • Postgraduate in Pharmacy/Science.
  • High attention to detail.
  • Good interpersonal skills.
Nice-to-Have Skills
  • Knowledge on Regulatory requirements of post-approval changes.
  • Basic level of knowledge on general standards, processes, and policies of Pfizer/Pharmaceutical manufacturing Industry.
  • Understanding of both pharma industry and scientific academic research environments.
Work Location Assignment

This role offers a hybrid work arrangement.

About Us

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

Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT that connects talent with opportunities in various domains.

Estimated Salary Range:

$80,000 - $110,000 per annum based on location and experience.



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