Junto HLS has been exclusively engaged by a Top 20 pharma client to recruit an Associate Director, International Regulatory to develop and lead the execution of Emerging Markets regulatory strategies.
- Oversees as well as develops and executes international regulatory strategies for product lifecycle, including product development and pre-/post-marketing (all therapeutic areas, biologics and small molecules).
- Independently manages, plans, and ensures execution of the regulatory submissions to support product development and approval efforts for all pre- and post-market products (all indications) in non-US and EU countries (e.g., primarily focusing on the emerging markets including Asia pacific, Latin America, Russia, India, etc. but also include other developed countries such as Japan, Australia, S. Africa).
- Manages direct reports and necessary support staff to ensure proper planning, management and execution of regulatory submissions to support product development and approval efforts for all pre- and post-market products (all indications) in non-US and EU countries.
- Represents client in Health Authorities meetings and leads or supports preparation activities for meetings with HA, as required. Interacts directly with HA and participates in agency meetings and may facilitate, depending on experience.
- Evaluates country-specific regulations and local environments to assess impact and provide guidance. Helps define strategic direction in the development of the international component of the Regulatory Development Plan for programs in development.
- Stays current with revised regulations/guidance for impact on product development plans in order to propose and implement appropriate changes.
- Works closely with functional areas throughout the company. Advises functional areas regarding content requirements for international regulatory submissions; review documents from functional contributors for consistency and completeness.
- Greater Boston Area, MA
If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to DanFarina@JuntoHLS.com.