Cmc Senior Manager

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

• 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.
• Prepare and review CMC submission documents, registration dossiers, and responses to health authorities through collaborations with relevant line functions and with minimal supervision.
• May be responsible for the global regulatory evaluation of CMC change controls with supervision.
• Work with CMC cross-functional teams and Regulatory Affairs teams.
• 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

Job Types: Contract, Temporary

Pay: From $85.00 per hour

Experience:

• CMC: 3 years (Preferred)
• Pharmaceutical industry: 5 years (Preferred)

Work Location: Remote