Regulatory Affairs Manager

Summary:

Someone with a mixed background not just lab but manufacturing and process development. This manager position within CMC will facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.

Responsibilities:

Assist Regional Regulatory Representative to support regional regulatory activities (e.g. IMPD development and submission, advisory committee meeting preparations)

Create and maintain product regulatory history documents through IMR and appropriately archive all regulatory documents and agency communications.

Ensure compliance with submissions regulatory agencies

Coordinate QC of regulatory documentation (e.g. briefing packages)

Top 3 Must Have Skill Sets:

Change Control evaluation or owner

QA, Manufacturing or Operations background experience

Process Development experience for biotech products

Day to Day Responsibilities:

Assess change control records supporting ATO and ESQ areas

Support submissions with site related documents, as requested

Provide support for variation process

Compensation:

The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on a number of factors, including but not limited to, a candidate's qualifications, skills, competencies, experience, location and end client requirements).

Benefits and Ancillaries:

Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.