Sr. Mgr., Regulatory Affairs (50592848) Coventry, Rhode Island

Responsible for compiling and reviewing data for regulatory submissions covering Rhodes Technologies products.

PRINCIPAL ACCOUNTABILITIES:

- Prepare, compile and publish regulatory submissions
- Track/update regulatory submissions in US and foreign countries
- Respond to customer inquiries in support of their regulatory filings
- Provide regulatory guidance and support to effected Rhodes Technologies departments
- Review change controls for any possible regulatory impact

Educational Requirements

Minimum Bachelor degree in science preferably PhD in organic chemistry. Two years experience with US CMC filings. Familiarity with foreign filing requirements desirable.

Required Experience & Technical Requirements

- Knowledge of CMC (Chemistry, Manufacturing & Controls) requirements for Active Pharmaceutical Ingredients (APIs) - required for Drug Master Files and providing support information to NDA/ANDA sponsors.
- Knowledge of chemistry (especially Organic Chemistry) to understand complex chemical reactions and review and approve internal regulatory documents (e.g. Development Reports, Validation Protocols, Investigations).
- Knowledge of FDA Regulatory Requirements relating to Facility Registration, Drug Listing and DMFs - responsibility for updating and tracking various filings and registrations. Eventual responsibility for updating and tracking foreign filings.
- Must possess analytical skills and be detail oriented.
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