Regulatory Affairs Specialist – Peru

About the role

We are seeking an experienced Regulatory Affairs Specialist based in Peru to lead pharmaceutical product registration and shape regulatory strategy for our portfolio. As the local RA representative, you will be the primary liaison with DIGEMID and a key bridge between our international team and the Peruvian market.

Key responsibilities

• Manage end‑to‑end pharmaceutical product registration in Peru, from dossier review to final approval.
• Act as the main contact with DIGEMID, handling queries, deficiency letters, renewals and variations.
• Provide regulatory guidance to the international RA team based on Peruvian requirements.
• Coordinate documentation preparation with Manufacturing, QA, RA and other internal functions.
• Ensure timely completion of all submissions and maintain post‑registration lifecycle activities.
• Deliver market intelligence on competitors, distributors and regulatory developments.
• Support Business Development in evaluating new product opportunities for Peru.
• Monitor legislative changes and flag potential impacts on the portfolio.

Required profile

• Degree in Pharmacy, Pharmaceutical Sciences, Life Sciences or related field.
• Minimum 5 years of regulatory affairs experience within the Peruvian pharmaceutical market.
• Proven success registering products with DIGEMID.
• Strong knowledge of Peruvian pharmaceutical regulations and submission framework.
• Fluent Spanish (native/near‑native) and good English communication skills.
• Ability to work independently while collaborating across time zones.

Required skills