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.

The Senior Director, Regulatory Affairs Compliance will be responsible for Mylan’s overall global regulatory audit strategic planning, processes and projects and provide ongoing updates of the auditing progress and strategic plan. The incumbent in this role will also be responsible for directing audits of the existing approved dossiers and the creation of Summary of Product Particulars for each product.

In this dynamic role, the Senior Director, Regulatory Affairs Compliance will:

• Develop procedures and methods for regulatory compliance audits, develop operational practice for the Regulatory Compliance group, develop training program for Auditors and provide management oversight of the Regulatory Auditing Group;

• Direct and confirm the accuracy of Mylan’s existing approved dossiers, including export dossiers, to current operating procedures and documents and to Health Authorities requirements and regulations;

• Review and approve audit plans and reports and provide management updates on the progress of the audits, audit trends and audit resolutions.  Notify management of significant observations;

• Provide independent review, comprehension, and discussion of departmental and corporate policies and procedures with multiple levels of employees and Management;

• Direct the compilation of compliance files/summary of product particulars for each marketed product (with country specifics identified) per manufacturing site;

• Direct the periodic ongoing maintenance audits of approved dossiers to ensure continued compliance of the dossier to current operating procedures;

• Develop procedures and program to be used to conduct audits of in-licensed (third party) dossiers to confirm data integrity and dossier accuracy before submission to Health Authorities.  Oversee and direct such audits;

• Direct and conduct random audits of a selected percentage of internally developed dossiers prior to submission or during Health Authority review;

• Provide audit support to the Pharmacovigilance Department including auditing internal country level programs.  Prepare and participate in Health Authority inspections of country level PV programs;

• Development and oversight of program to monitor compliance of Advertising and Promotion Regulatory Activities;

• Collaborate with Quality in the establishment and regulatory oversight of Global and Local Change Control Systems;

The successful candidate in this role will have a minimum of 12 years of experience with a BS or a minimum of 10 years experience with MS.  However, a combination of experience and education will be considered.

Candidates must possess knowledge of GLPs, GCPs, GMPs, SOP’s, GXP concepts and have strong understanding of regulatory operations and  requirements, regulatory compliance,  manufacturing and quality, supply chain, and pharmaceutical technology throughout the world.  Candidates must also possess a sound knowledge of cGMPs, GCPs, GMPs sufficient to readily interpret, lead discussion, and provide guidance based on the applicability of the regulations to the subject being audited.

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.  If you are ready to meet this challenge, we invite you to join our team!  To learn more about this opportunity, and to apply online, please visit our Career website at http://www.mylancareers.com / (MLI_10_001484).

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 – Taking pride in diversity.