Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates the world's third largest active pharmaceutical ingredient manufacturer; and runs a specialty business focused on respiratory and allergy therapies. For more information, please visit www.mylan.com.

In this role, the Director, Global Regulatory Affairs is responsible for providing regulatory strategy and guidance on new drug development with a focus on the regulatory strategy for Mylan’s North America biosimilars platform as well as the Clinical Regulatory aspects of Mylan's branded and generic development. This position entails regulatory leadership on various cross functional project teams, strong interaction with Technical Operations personnel at manufacturing sites and other key partners both internal and external to the company.  This position requires the ability to independently manage multiple projects to prioritize work in alignment with company objectives.  This position will interact directly with the FDA and with other Health Authorities through local regulatory managers with minimum management oversight.

The Director, Global Regulatory Affairs will:

• Formulate, lead and drive the regulatory strategy for assigned development projects and/or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance;

• Provide regulatory expertise to biologic products across multiple therapeutic areas and technical initiatives;

• Provide expert regulatory affairs knowledge and insure implementation in the global Bio-similar strategy by providing North America regulatory strategy;

• Participate with the clinical team in the development of clinical programs and protocols required to meet the Health Authorities (HA) requirement for product approval;

• Direct and oversee the preparation, review and submission of INDs/CTXs/CTAs, amendments, reports and correspondences (including but not limited to safety reports, Annual Reports, Protocol Amendments, and Information Amendments);

• Supervise and review the preparation, Health Authorities (HA) filing and maintenance of dossiers including original applications, amendments, supplements, variations, renewals, annual reports, labeling, responses to HA inquiries/comment letters, safety reports and other Agency correspondences;

• Act as the primary liaison with the HAs regarding clinical issues with regard to assigned projects; 

• Review pharmacology, toxicology, pharmacokinetic clinical reports, protocols, investigator brochures, consent forms and clinical drug releases for completeness, consistency and compliance with regulatory requirements;

• Provide regulatory oversight with regard to the preparation, submission and revision of new and revised labeling for branded products;

• Manage the regulatory aspects pertaining to the compilation, submission and review of information required to fulfill Phase IV regulatory commitments for approved products.

The candidate will possess a B.A. or B.S. degree in science or health-related discipline and 10 years pharmaceutical industry experience. An advance degree is preferred.   However, a combination of experience and/or education will be taken into consideration.  The successful candidate should be experienced within regulatory affairs in the field of biologics and clinical development, including responsibilities for successful prosecution of development milestones and/or marketing authorization (e.g. EOP1/EOP2/preNDA(BLA) meeting facilitation and negotiation, label negotiations, regulatory responses).  Demonstrated established relationships with key FDA (CBER and CDER) stakeholders (e.g. project managers, reviewers and/or decision makers).

At Mylan, we are not satisfied with anything less than being the best.  As one of the world's leading generic and specialty pharmaceutical companies, the key to our success starts with a relentless drive to set the highest industry standards in everything we do.  It takes exceptional people working together to achieve excellence.  As a team, we earn our customers’ trust and loyalty by placing a high premium on always doing the right things in the right way.

To learn more about this opportunity, and to apply online, please visit www.mylan.com and click on Careers (MLI_10_001486).

Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. Mylan is an Equal Opportunity Employer, M/F/D/V.

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