The Director, Regulatory Affairs CMC will effectively liaise, negotiate and partner with FDA; direct, coordinate and implement the preparation of CMC Sections of all regulatory submissions and provide regulatory CMC support across all projects, securing the cooperation of others (team members); meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval of pharmaceutical applications for the company's growth, thereby accomplishing corporate goals.
- Liaise, negotiate and orchestrate meetings and teleconferences with FDA; strategize and plan for FDA meetings; capture all communicates. Interact with FDA on submissions for CMC issues to ensure rapid preparation and approval of submissions and resolution of queries.
- Manages, prepares, and compiles well organized scientifically sound CMC related regulatory submissions to ensure completion within project timelines and to satisfy FDA requirements.
- Provides detailed risk assessments for regulatory submissions and works with the technical groups to assure successful implementation of mitigation measures
- Evaluates changes control for determination of submission type and regulatory documentation requirements. Prepares reviews and compiles supplemental submissions to assure timely FDA approval.
- Prepares CMC sections of INDs/NDAs, amendments, supplements and annual reports including the compilation and review of the required data, scientific reports and written submission contributions and ensures timely completion.
- Serves as the regulatory CMC representative on core teams, develops and plans regulatory CMC submission strategy and proactively identifies CMC issues to pharmaceutical development and post marketing projects. Provides guidance to technical team members for the requirements and content of regulatory CMC documentation.
- Develops and implements the regulatory CMC project plan from IND to NDA and the post marketing phase to support submissions in the US.
- Interface with regulatory authorities at all appropriate stages of drug development to ensure the regulatory success of the company's CMC programs. Develop professional relationships with key regulators within those FDA Divisions with which the company interacts.
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
- Qualified candidates must have a Bachelor's degree from an accredited college or university; BS degree in science, pharmacy or other scientific discipline. Graduate degree is preferred. Regulatory affairs certificate is desirable.
- 9-14 years of Pharmaceutical Industry experience including a minimum of 5 years of regulatory or related experience
- Advanced and comprehensive knowledge of regulations/guidance documents and corporate industry standards and an ability to evaluate same for impact on strategic plans and tactical operations. With strong scientific technical knowledge, provide committed value added effort in support of development and commercial projects.
- Ability to establish strong relationships with Corporate and Divisional Partners and regulatory Health authorities along with company stakeholders on a cross functional basis including Marketing, Legal, Technical, Quality, Supply Chain, Clinical Regulatory to ensure perfect alignment and synchronization between Regulatory processes and strategic business goals.
- Experienced in supervising, coaching, motivating, and mentoring junior staff members including effective work delegation.
- Thorough understanding of the core processes of development, manufacturing and marketing. Solid knowledge of regulatory submission procedures including CMC requirements for filing and maintaining INDs and NDAs.