Role Overview

We are looking for an experienced, locally based Regulatory Affairs Specialist to lead pharmaceutical product registration and regulatory strategy in Peru. This role is central to ensuring our products reach the Peru market efficiently and remain compliant throughout their lifecycle. As the local RA representative, you will act as the primary point of contact with Peru health authorities and as a critical link between our international team and the local market.

Key Responsibilities

- Manage the complete pharmaceutical product registration process in Peru — from dossier review and submission through to final approval.
- Serve as the primary local liaison with Peru regulatory authorities (DIGEMID), handling queries, deficiency letters, renewals, and variations.
- Review registration requirements and provide expert regulatory guidance to the international RA team.
- Coordinate the preparation and compilation of required documentation with Manufacturing, QA, RA, and other internal teams.
- Ensure all registrations and submissions are completed within agreed timelines.
- Maintain existing product registrations and manage all post-registration lifecycle activities.
- Provide local Peru market intelligence, including insights on competitors, regulatory developments, distributors, and market opportunities.
- Support the Business Development team in identifying and evaluating products suitable for the Peru market.
- Monitor changes in Peru pharmaceutical legislation and proactively flag impacts on the product portfolio.

Requirements

- Degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related field.




- Minimum 5 years of pharmaceutical Regulatory Affairs experience in Peru — this is a local-market role and candidates must currently reside in Peru.
- Proven track record of successfully registering pharmaceutical products with Peru health authorities.
- Strong working knowledge of Peru pharmaceutical regulations, registration procedures, and the DIGEMID submission framework.
- Solid understanding of the local pharmaceutical market landscape, including key distributors and competitors.
- Fluent Spanish (native/near-native) with good English communication skills, written and spoken.
- Strong follow-up, cross-functional communication, and problem-solving skills.
- Ability to work independently while collaborating closely with an international team across time zones.

Preferred Qualifications

- Existing relationships or established rapport with Peru regulatory authorities.
- Experience supporting due-diligence or product-licensing evaluations for market entry.
- Familiarity with international regulatory frameworks (e.g., WHO / MHRA/ EU / PIC/S, ICH) as they apply to Peru requirements.

Key Objective Successfully secure pharmaceutical product registrations in Peru while providing strong, on-the-ground regulatory and market support that enables the company's continued growth in the local market.

Why Join Us

- Play a pivotal role as the trusted local regulatory expert for a growing international portfolio.
- Work at the intersection of regulatory strategy, market access, and business development.
- Direct collaboration with a integral RA team and exposure to cross-border pharmaceutical operations.

📌 Regulatory Affairs Specialist (Lima)
🏢 Orbit Pharmaceuticals
📍 Lima