Sr Regulatory Consultant (Biologics/Biosimilars) Syneos Health

8.0 - 12.0 years

0 Lacs

pune, maharashtra

On-site

As a Sr Regulatory Consultant specializing in Biologics/Biosimilars at Syneos Health, you will play a crucial role in authoring and reviewing CMC sections of regulatory submissions for various applications. Your responsibilities will include: - Authoring and reviewing CMC sections of regulatory submissions such as INDs, IMPDs, CTAs, BLAs, and MAAs, as well as briefing packages and health authority responses. - Ensuring completeness and compliance of CMC sections within IND and IMPD applications based on regulatory guidance (FDA, EMA, ICH). - Providing peer review and mentorship to junior writers or team members to maintain consistency and scientific accuracy across deliverables. - Staying up...

Posted 1 month ago

AI Match Score

Apply

Technical Specialist- MSAT Global Value Web

7.0 - 10.0 years

0 Lacs

hyderabad, telangana, india

Remote

Job Title: Technical Specialist - MSAT Experience: 7 to 10 Years Position Type: Permanent Location: Bengaluru OUR COMPANY Global Value Web (GVW) is a value chain enabling company headquartered in The Netherlands with offices across North America, Europe, and India in global value chains of Pharmaceutical / Life Science, Chemical and Oil & Gas/Energy companies. Through remote and on-site managed services, GVW strives to assist the client's talent, from scientists, business professionals, managers and directors, so they can focus on what they do best - their core areas. GVW then manages the contextual or enabling services by gathering, cleansing, organizing, curating, and analyzing the data in...

Posted 2 months ago

AI Match Score

Apply

Sr Regulatory Consultant (Biologics/Biosimilars) Syneos Health

8.0 - 12.0 years

0 Lacs

pune, maharashtra

On-site

As a Senior Regulatory Consultant specializing in Biologics/Biosimilars at Syneos Health, you will play a crucial role in authoring and reviewing CMC sections of regulatory submissions for various applications such as INDs, IMPDs, CTAs, BLAs, and MAAs. Your responsibilities will include developing and ensuring the completeness of CMC sections within IND and IMPD applications while adhering to regulatory guidance from FDA, EMA, and ICH. Your expertise in analytical method development, validation, comparability, biosimilarity assessments, upstream and downstream process development will be essential. Furthermore, you will provide peer review and mentorship to junior writers or team members to ...

Posted 3 months ago

AI Match Score

Apply

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.