Senior Regulatory Affairs Specialist

Job Responsibilities:

Report directly to the VP of Regulatory Affairs & QA.

Lead the FDA registration project for combination drug-device products (IND, NDA).

Provide expert guidance on GMP regulations, leveraging previous experience in a GMP compliance environment.

Manage regulatory activities concerning the Drug Substance and Drug Product, including the formulation and execution of regulatory strategies.

Serve as a senior consultant for CMC (Chemistry, Manufacturing, and Controls) and Drug Development Regulatory Registration and assist in the regulatory writing of CMC documents for regulatory submissions purposes.

Act as a team member and proactive participant in meetings pertaining to IND registrations of drug products, engaging with both internal and external stakeholders.

Ensure coherence, comprehensiveness, and adherence to standards for all regulatory submissions.

Participate in clinical study management meetings, taking responsibility for offering regulatory insights into ongoing and planned clinical trials. Review and comment on the regulatory aspects of clinical trial protocols/reports and their pertaining documentation (IB, IMPD, etc.’).

Stay updated with shifts in regulatory legislation and guidelines to ensure continuous compliance.

Oversee and supervise vigilance activities and associated documentation.

Define requirements for labeling and packaging in accordance with regulatory standards.

Position Requirements:

Possess a minimum of 6 years of experience in the regulatory affairs department of pharmaceutical companies (excluding startups).

Demonstrated expertise in IND registration for drugs/pharmaceuticals.

Previous active involvement in various aspects of drug development related to regulatory affairs, with a strong understanding of CMC and related activities.

Previous participation in regulatory processes concerning the compilation of Phase II and Phase III Clinical Study protocols, including regulatory documentation for clinical trial approvals from global competent authorities and the FDA.

Familiarity with regulatory affairs for medical devices and knowledge of design control as per ISO 13485 would be considered a plus.

BA Degree in Life Science and/or Engineering.