Regulatory Affairs Manager

Regulatory & Medical Affairs - Regulatory Studio - CMC Senior Manager

Location: Hybrid (50% onsite) at either Lawrenceville in US or (US 100% Remote)

Job Description:

PREREQUISITES BS/BA degree in Scientific Discipline (Masters or higher preferred) with

5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience, Sterile Injectable experience preferred.

Responsibilities will include, but are not limited to, the following:

1. Participate in the development of the CMC regulatory strategy for post-approval small molecule product submissions, including global supplements/variations and responses to health authority queries.

2. Prepare and review CMC submission documents, registration dossiers, and responses to health authorities through collaborations with relevant line functions and with minimal supervision.

3. May be responsible for the global regulatory evaluation of CMC change controls with supervision.

4. Work with CMC cross-functional teams and Regulatory Affairs teams.

5. Develop and maintain knowledge of regulatory environment, regulations and procedures.

Skills/Knowledge Required:

- Experience with CMC regulatory documents (global registrations, including NDAs, MAAs and others, responses and supplements/variations)

- Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations

- Experience in post-approval requirements

- Experience in developing CMC regulatory strategy

- Experience in project management

- Have a solution-oriented approach to problem solving

- Ability to plan/prioritize work of group members and guide/develop others.

- Ability to work on complex projects and within cross-functional teams with supervision

- Excellent communication skills, both written and oral

- Excellent computer skills