Regulatory Affairs Cmc Jobs

Knowledge or experience with regulatory requirements in other regions and familiarity with GMP regulations is a plus.

In-depth knowledge of ICH requirements and regulatory requirements in the US/EU.

Proficiency in authoring complex technical documents, including CTD M2 and M3 sections, and life cycle management.

8+ years of experience in regulatory CMC within the pharmaceutical or biopharmaceutical industry.

Excellent oral and written communication skills are essential.

Detail-oriented, self-motivated, and comfortable handling broad responsibilities in an entrepreneurial, fast-paced environment.

80% employer-paid MEDICAL HMO plan

80% employer-paid DENTAL PPO plan

We are in works to add 100% employer-paid Basic Life/AD&D + ST Disability

We will eventually also add a Medical PPO plan

Maintains current knowledge of regulations and guidelines (FDA, ICH, and others as required).

5-10 years experience in regulatory CMC

Coordinate and lead the task of drafting responses to CMC-related questions from FDA or foreign health authorities.

Work with functional groups to provide timely responses to CMC questions from regulatory authorities.

Coordinates activities for meetings with FDA and other regulatory authorities.

Coordinates with cross-functional teams to define contributions to submissions.

•Strong leadership qualities including strategic thinking, innovation, people management, project management and excellence in communication

Position - Senior Manager (SM) Regulatory Affairs CMC (Small molecules)

•Manage post approval changes where needed

Qualifications we seek in you!

•Prior experience in big (or mid-size) Pharma companies

•Robust communication and presentation skills