or apply directly on Summit Therapeutics's site. We never take the application ourselves.
Is this posting real?
- This role has been open
- 81 days Summit Therapeutics's roles stay open a median of 64 days
- Reposted
- No
- Salary listed
- No 0% of Summit Therapeutics's roles list one
- Ghost-job risk at Summit Therapeutics
- high 78 stale, 3 reposted of 80 open
- Hiring momentum
- 111 roles opened in the last 90 days ↑ up vs. the prior 90 days
- Last confirmed on the employer's board
- 2026-10-23
Measured from postings appearing on and disappearing from Summit Therapeutics's own greenhouse board since 2026-08-03. Full hiring picture for Summit Therapeutics.
About this role
The Associate Director, Regulatory Affairs, CMC will coordinate and prepare global regulatory filings, providing regulatory strategy input and overseeing submissions in collaboration with various stakeholders. This role involves managing CMC aspects of compounds through development phases, ensuring compliance with regulatory requirements, and supporting interactions with Health Authorities.
- benefits
- 1/5
- freshness
- 1/5
- career value
- 4/5
- role clarity
- 4/5
- pay transparency
- 0/5
Scored from the posting itself — how clearly the role is described, how much it says about pay and benefits, and how recently it was listed. Not a judgement of Summit Therapeutics as an employer.
What you need
- Bachelor's Degree in Chemistry, Pharmacy, Engineering, Biochemistry or related science
- 6 or more years of Regulatory CMC experience and/or related Pharmaceutical industry experience
- Experience in biologics
- Thorough and extensive knowledge of FDA and EU regulations
- Experience in preparation of CMC sections for regulatory submissions (IND, IMPD, BLA, MAA, Amendments, Supplements)
- A good understanding of IND, CTA, BLA and MAA
Nice to have
- Master's Degree or other advanced degree
- Proficiency in Mandarin Chinese (spoken and written)
- Experience using electronic document management systems and document review tools
What you get
- Pay range of $194,000 - $199,000 USD
- Total compensation may include bonus, stock, benefits, and/or other variable compensation
Worth weighing
- Hybrid work model with 4 days on-site required
- No specific mention of additional benefits or perks beyond compensation
- Role requires effective multi-tasking and managing time-sensitive tasks
Summarised from Summit Therapeutics's posting. Read the full original.
Listed by Summit Therapeutics on their greenhouse job board, last confirmed open on 2026-10-23. PitchMeAI is not the employer.
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