DIRECTOR INTERNATIONAL REGULATORY AFFAIRS
Opportunity Profile:
The role of the Director, International Regulatory Affairs, is to direct departmental management and assist regulatory colleagues at Mylan’s international affiliates in helping ensure that the corporate objectives pertaining to international product registration and marketing are met. This is accomplished by understanding the objectives of the company and by maintaining a direct interface and constant communication with international affiliates responsible for product registration outside the U.S. To carry out these responsibilities it is necessary to have a strong working knowledge of the regulations and guidelines associated with product registration and marketing in countries outside the U.S. The Director will also partner with international API and FDF manufacturing facilities to evaluate proposed manufacturing changes and help determine appropriate regulatory strategy for filing and implementing such changes.

Essential Duties & Responsibilities
Support Mylan’s global registration initiatives by overseeing and directing departmental staff in the process of assuring that regulatory requirements associated with the preparation, submission, and approval of non-U.S. product registration dossiers are continually being met.

Provide direction and assistance, as appropriate, in the preparation and review of product registration dossiers prior to submission to health authorities to assure that they are complete, organized, of high quality and compliant with applicable regulations and guidelines.

Help insure that product registration dossiers for approved products are maintained in accordance with current regulations and guidelines.

Interact directly with regulatory colleagues at Mylan’s international affiliates to help resolve registration issues and expedite the product registration process.

Maintain a strong working knowledge of the regulatory requirements within the European Union and other major markets where products are planned to be registered.

Provide expertise and guidance in interpreting regulations and guidelines pertaining to the international product registration process.

Assist international regulatory colleagues in the development of regulatory strategies for the registration and marketing of products outside the U.S.

Assist international regulatory staff with regards to working with regulatory authorities to develop solutions consistent with defined strategy and registration requirements.

Oversee and direct the compilation and transfer of regulatory documentation between the U.S. and EU/ROW affiliates.

Oversee the maintenance of a tracking system for anticipated, pending and approved product marketing registrations in order to provide immediate feedback and input on product registration status to department management.

Provide update reports to V.P. Corporate Regulatory Affairs and Senior Company Management concerning project status.

Oversee and direct the activities of department staff in the Morgantown-based International Regulatory Affairs Department.

Provide ongoing feedback, coaching, and career development support to staff in order to maximize their potential.

Travel to international affiliate facilities on a periodic basis to meet and work with regulatory colleagues.

Assist in development of departmental budget.

Perform other duties as assigned.

Qualifications:
B.S./B.A. in a science or health related discipline plus a minimum of 16 years experience in the Pharmaceutical industry or related field and 10-13 years experience in Regulatory Affairs; M.S. or PharmD, plus 14-16 years experience in the Pharmaceutical industry and 8-10 years experience in Regulatory Affairs. Must possess previous hands-on experience in the preparation, review, submission and approval of product registration dossiers in countries outside the U.S. Experience with CTD and electronic submissions is desired. Must possess a strong working knowledge of the regulatory process pertaining to drug development, international product registration, review and approval and have a good working knowledge of the regulations and guidelines associated with product registration and marketing in the European Union and other countries and regions of the world. Must also be able to read, understand and interpret various pharmacopeial publications. Prior supervisory experience is expected.