Senior Regulatory Affairs Manager
Novo Nordisk
full-time
Posted on:
Location Type: Office
Location: Panama City • 🇵🇦 Panama
Visit company websiteJob Level
Senior
About the role
- Lead the region’s approach to regulatory advocacy, intelligence, and Loss of Exclusivity (LoE)
- Act as the main link to Global Regulatory and engage with authorities and trade associations
- Shape regional policy positions and guide affiliates
- Ensure BASAC is prepared for upcoming LoE milestones through coordinated planning and clear regulatory frameworks
- Monitor regulatory trends and translate them into risks, opportunities, and action plans
- Develop tools and standards to harmonize regulatory processes across markets
- Ensure consistent regulatory positioning in meetings with agencies and policy groups
Requirements
- 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
Benefits
- Opportunities to learn and develop
- Tailored benefits designed for your career and life stage
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory advocacyregulatory intelligenceLoss of Exclusivity (LoE)pharmaceutical regulatory experiencebiosimilarsgenericsbiologicsGLP-1slifecycle changespost-approval changes
Soft skills
communicationnegotiationanalytical skillsstakeholder influenceautonomystrategic planningpolicy shaping
Certifications
Bachelor’s degreeadvanced degree in Pharmacyadvanced degree in Life Sciencesadvanced degree in Regulatory Affairs