At PPD, you'll have the freedom to try new ideas and the ability to do something truly great. In our environment, innovation is encouraged. That's why the world's leading pharmaceutical and biotechnology companies come to us for discovery and development services. And why PPD is the best choice for you and for your career. Vice President, Regulatory Affairs Description Reporting to the Senior Vice President, Global Regulatory Affairs and Strategic Product Development, the Vice President, Global Regulatory Affairs will provide oversight and direction to the RA personnel responsible for global regulatory development, registration, and post-marketing strategy for products in all therapeutic areas with a specialization in biologics/vaccines. The candidate will have a broad range of experience (clinical, CMC, preclinical) including all phases of the product development and registration processes for both drugs and biologics. This individual will contribute to the development of strategic and operational plans through sound assessments of potential regulatory pathways and risks. Such assessments may influence the scientific or technical direction of product design and/or development. The candidate will also provide support for critical due diligence activities related to on-going licensing and acquisition opportunities. The candidate will have a proven track record in leading meetings with the U.S. Food & Drug Administration and the European Medicines Agency and in obtaining NDA/BLA/MAA approvals.
This highly committed, results-oriented individual must be innovative and forward-thinking, have demonstrated leadership skills, success in developing, mentoring and managing direct reports and be able to effectively manage the balance between delegation/empowerment and a hands-on approach. The ability to work successfully across functions and cultures in a highly matrixed, global organization is critical. Qualifications Basic Qualifications:
PhD, PharmD, or MD degree or a minimum of 20 years industry experience
10+ years' regulatory experience in the biotechnology/pharmaceutical industry
At least five years in a senior leadership role managing a large (> 50) global group
Preferred Qualifications:
PhD, PharmD, or MD degree with a minimum of 15 years industry experience
10+ years' regulatory experience in biotechnology/pharmaceutical industry
At least five years in a senior leadership role managing a large (> 50) global group
Integrity and credibility; strong influencing, communication, and training skills; solid scientific and product understanding; wide-ranging knowledge of global regulatory authority regulations and industry guidances; experience in a variety of therapeutic areas are desirable as is active participation in industry trade associations. The Vice President, Global Regulatory Affairs will be capable of identifying and communicating potential risks and mitigations associated with regulatory strategies to stakeholders. The individual would be required to demonstrate excellent business development capabilities to facilitate the securing of regulatory consulting contracts.
PPD is an Equal Opportunity Employer
Additional Information
Position Type: Full Time, Employee
Ref Code: 00290  
| 
