Description
Key Responsibilities:- Develop/refine strategic excipient and formulation regulatory plans for global development programs including Master Files, Common Technical Documents and CMC sections
- Represent at FDA and international governmental agencies to provide chemistry, manufacturing and control information for development programs and marketed products;
- Provide guidance and advice to product internal and external teams to achieve goals related to drug development and commercialization
- Develop and implement strategies for the most efficient and timely submission and approval of regulatory filings, from IND/CTA through Phase 4;
- Develop regulatory processes, procedures and infrastructure to support audit ready pharmaceutical expansion
- Provide Regulatory CMC guidance for compliance matters, including facility inspections by global health authorities
- Oversee regulatory project management of CTD, CMC programs, coordinating critical activities in accordance with time-lines, budgets, SOP's, and regulatory requirements;
- Manage all regulatory compliance aspects of post-marketing activities,
- Direct and develop the regulatory staff reporting to position;
- Provide technical regulatory input to business development opportunities as needed
Supervisory responsibilities: Will oversee department staff and cross functional teams
Education and Experience:
* Bachelor degree in health or life sciences
* 15 years of pharmaceutical industry experience, including 5 years in regulatory affairs CMC
* Working knowledge of US and international drug and biologics guidelines and regulations
* Hands-on experience working with the FDA and International regulatory authorities from pre-approval to post-marketing, with a proven track-record of submissions and approvals with the FDA and other regulatory agencies.
Qualifications:
* Exceptional leadership and problem solving skills
* Full life cycle communication experience in generating written deliverables to pharmaceutical submissions, responses, audit reports, annual reports
* A demonstrated track record of creative Regulatory issue resolution
* Experience with FDA and International Authority Inspections
* Ability to create horizontal and vertical alignment across the enterprise
* Driver of operational excellence and adherence to milestone planning