CMC Regulatory Affairs Manager

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Job description

Rersponsibilities :

Bachelor's, Master's, or Ph.D. degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or related scientific discipline.

5-7 years of experience in regulatory affairs CMC in the pharmaceutical industry.

Demonstrated expertise in preparing CMC sections of regulatory submissions (e.g., INDs, NDAs, BLAs, MAAs, IMPDs) and interacting with global health authorities (e.g., FDA, EMA, Health Canada, PMDA).

Strong understanding of global regulatory requirements, guidelines, and expectations related to CMC for pharmaceutical products (e.g., ICH guidelines, FDA regulations, EudraLex).

Excellent communication, collaboration, and project management skills, with the ability to effectively interact with cross-functional teams and external stakeholders.

Proven ability to prioritize tasks, manage multiple projects simultaneously, and meet deadlines in a fast-paced, dynamic environment.

Detail-oriented mindset with a focus on quality, accuracy, and compliance.

Experience with regulatory submissions for small molecules, biologics, or other pharmaceutical modalities is preferred.

Regulatory Affairs Certification (RAC) is a plus.

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