Parexel Regulatory Affairs Job Opening For BSc, MSc Life Sciences – Apply Online
Parexel Regulatory Affairs Job Opening For BSc, MSc Life Sciences – Apply Online. Bachelors/ Masters in any of Life Sciences candidates can apply for a Senior Regulatory Affairs Associate job at Parexel. Interested and eligible applicants can check out all of the details on the same below
Senior Regulatory Affairs Associate
Location: Bengaluru, India
Job ID: R0000003109
Category: Regulatory / Consulting
Senior Regulatory Affairs Associate
Experience: Biologic CMC
5+ years of experience
Supported the CMC activities related to Vaccine/Biologic manufacturing and control including authoring of submission dossiers related to:
- new application, post approval variations
- Understanding of EU/CA/WHO/US regulations & guidance allowing appropriate review and compilation of data to appropriate standards & requirements
- Experienced in CTD update/authoring ( CTD Module 1, 2&3)
- Handled and responded Health Authorities Request
- US & CA Annual reports, Renewals, PQVAR, APR
- Assessment of the Change Controls and associated technical dossiers
- Excellent individual project management and communication skills
- Veeva tool experience
Education:
Bachelors/Masters in Pharmacy OR Bachelors/ Masters in any of Life Sciences
- Question: Can you describe your experience in handling CMC activities related to Vaccine/Biologic manufacturing and control? Answer: Certainly, I have over 5 years of experience in supporting CMC activities for Vaccine/Biologic manufacturing and control. This includes authoring submission dossiers for new applications and post-approval variations.
- Question: How familiar are you with the regulations and guidance from EU/CA/WHO/US pertaining to biologics, and how do you ensure compliance in your work? Answer: I have a thorough understanding of EU/CA/WHO/US regulations and guidance related to biologics. I ensure compliance by meticulously reviewing and compiling data to meet the appropriate standards and requirements set forth by these health authorities.
- Question: Have you been involved in handling CTD update and authoring (Module 1, 2&3)? Can you provide an example of such experience? Answer: Yes, I have experience in CTD update and authoring for Module 1, 2&3. For instance, in my previous role, I was responsible for updating the Module 3 section of a vaccine dossier to include new manufacturing data, which contributed to a successful regulatory submission.
- Question: How have you managed and responded to Health Authorities Requests in your previous projects? Answer: In the past, I have effectively managed and responded to Health Authorities Requests by promptly addressing their queries and providing comprehensive and well-documented responses. This involves collaborating with cross-functional teams to gather necessary information.
- Question: Can you tell us about your experience with US & CA Annual reports, Renewals, PQVAR, and APR? Answer: I have extensive experience in handling US & CA Annual reports, Renewals, PQVAR, and APR. In my previous roles, I have been actively involved in the preparation and submission of these documents to regulatory authorities, ensuring compliance and adherence to timelines.
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