Regulatory Sciences Expert
2 weeks ago
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).
- Postgraduate in Pharmacy/Science.
- High attention to detail.
- Good interpersonal 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.
This role offers a hybrid work arrangement.
About UsPfizer 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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