Manager/ Senior Manager, Regulatory Affairs Emerging Markets

Our client, a Top 20 Pharma has exclusively engaged Junto HLS to recruit a Manager/ Senior Manager, Regulatory Affairs Emerging Markets to develop and lead the execution of Emerging Markets regulatory strategies.

Position Overview:  

    • Develops and leads the execution of Emerging Markets regulatory strategies for product lifecycle, including product development and pre-/post-marketing (all therapeutic areas, biologics and small molecules).
    • Plans and executes the regulatory submissions to support product development and approval efforts for all 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 Australia, S. Africa).
    • Interfaces cross-functionally within RA, as well as with commercial, clinical development, global marketing, etc. to identify what Emerging Markets regulatory requirements are necessary and how to best move forward to meet project plans.
    • Evaluates country-specific regulations and local environments to assess impact and provide guidance.Helps define strategic direction in the development of the Emerging Markets component of the Regulatory Development Plan for programs in development.
    • Develops in-depth knowledge of regulatory requirements and environment for development and registration of new products for all Emerging Markets region such as Asia Pacific, Latin America, etc.
    • Manages interactions with Emerging Markets Health Authorities as necessary, successfully negotiating international matters.
    • In liaison with Global Regulatory Lead (GRL), helps develop core labelling for products with considerations for Emerging Markets requirements.

Location(s):

  • Greater Boston, MA

If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to Michelle@juntoHLS.com.