Regulatory Affairs Senior Manager

Regulatory Affairs Senior Manager- **Category**:Reg Affairs & Safety Pharmacovigilance- **Location**:Panama city, Panama, PA-
- Step into a role where you can truly influence regulatory environments, shape policy direction, and guide strategic decisions across the region. This position offers a rare opportunity to build a regulatory advocacy framework from the ground up, strengthen Novo Nordisk’s position throughout the BASAC region (Argentina, Chile, Colombia, SAM, CAC), and play a central role in preparing our portfolio for Loss of Exclusivity (LoE).
Based on-site in Panama, this role is ideal for someone who thrives in autonomy, enjoys engaging directly with authorities, and wants to leave a tangible impact on patient access and business strategy.-
- **Your new role**- As the Senior Regulatory Affairs Manager for BASAC, you will lead the region’s approach to regulatory advocacy, intelligence, and Loss of Exclusivity (LoE). This role acts as the main link to Global Regulatory and requires strong autonomy, strategic thinking, and solid engagement with authorities and trade associations. You will shape regional policy positions, guide affiliates, and ensure BASAC is well prepared for upcoming LoE milestones through coordinated planning and clear regulatory frameworks. Key responsibilities include:

- Leading regional advocacy and LoE strategies and aligning them with global guidance.
- Representing Novo Nordisk with regulatory agencies and trade associations to support science-based pathways.
- Building the BASAC LoE roadmap and coordinating cross-functional readiness with affiliates.
- Monitoring regulatory trends and translating them into risks, opportunities, and action plans.
- Developing tools and standards to harmonize regulatory processes across markets.
- Ensuring consistent regulatory positioning in meetings with agencies and policy groups.
- This role offers the opportunity to design new approaches, influence policy environments, and elevate regulatory excellence across BASAC.

** Your Skills and Qualifications**- Bachelor’s degree required; advanced degree in Pharmacy, Life Sciences, or Regulatory Affairs preferred.
- At least 5 years of pharmaceutical regulatory experience; regional LATAM experience is an advantage.
- Strong background engaging regulatory agencies (e.g., ANVISA, ISP) and trade associations.
- Demonstrated experience in advocacy, policy shaping, and stakeholder influence.
- Knowledge of LoE, biosimilars, generics, biologics, GLP-1s, and lifecycle/post-approval changes is highly valued.
- Ability to work with strong autonomy and propose strategic frameworks in a newly created role.
- Excellent communication, negotiation, and analytical skills.
- English and Spanish required.
- Must be willing to work 100% on-site in Panama with up to 20-30% regional travel.

** About the Department**- As part of International Operations, you will join our largest operational unit. Covering 194 countries and 95% of the world's population, more than 18,000 of us work passionately to serve 35 million patients each day. With a promise to outperform the competition, we continue to be the growth driver for Novo Nordisk, and to improve health at scale across the globe.-
- **Working at Novo Nordisk**- Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with an unconventional spirit, a rare determination and a constant curiosity. For over 100 years this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose, mutual respect and a willingness to go beyond what we know delivers extraordinary results.-
- **What we offer**- There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, wwhile ourbenefits are designed with your career and life stage in mind.-
- **More information**- ** Deadline***- We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.- We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.