Regulatory Affairs CMC (US Market) Life cycle management

Role & responsibilities

Review and authorize change controls, assessing their impact on regulatory submissions.

* Coordinate and organize meetings with cross-functional teams to discuss IRs, DRLs, and CR letters from agencies; circulate Minutes of Meeting (MoM) and follow up on action items.

* Compile and coordinate high-quality CMC regulatory submissions for the US market in compliance with current regulatory guidelines and timelines.

* Assess change controls from formulation plants and categorize them based on risk to product quality and compliance.

* Plan, review, and submit CBE, CBE-30, and Prior Approval Supplements (PAS).

* Draft high-quality responses to regulatory agency letters (IR, DRL, CR) within stipulated timelines.

* Evaluate and interpret post-approval changes including:

* Alternate excipients

* Alternate packing materials

* Alternate API source additions

* Site and pack additions

* Review key regulatory documents such as specifications, process validation reports, hold time reports, stability protocols/data, Nitrosamine risk assessment reports, and technical packages.

* Assist in developing standards and SOPs for operations and production procedures.

* Stay updated with evolving global and regional regulations affecting submissions.

* Provide daily activity updates to the Regulatory Affairs Manager.

* Prepare monthly reports and provide timely updates to superiors.

* Uphold the highest standards of professional integrity in all RA activities.

* Actively participate in continuous improvement initiatives within the department.

Preferred candidate profile

* Master's degree in Pharmaceutics, Pharmaceutical Analysis, Regulatory Affairs.

* Strong knowledge of US FDA regulatory guidelines and CMC documentation.

* Excellent communication, coordination, and documentation skills.

* Attention to detail and ability to manage multiple priorities effectively.