Otc & Regulatory Affairs Manager Setúbal

Otc & Regulatory Affairs Manager
Setúbal
Setúbal, Setubal, Portugal

Join to apply for the OTC & Regulatory Affairs Manager role at Ecuphar Portugal.

Animalcare Group is a sustainable and passionate organization committed to leading in animal health through innovative and trusted products and services to support the veterinary profession.

We care about the
- being of animals and the positive impact that healthy animals have on their owners and society. We have a direct commercial presence in seven European countries, with product sales in 40 markets.

As OTC & Regulatory Affairs Manager, you will ensure that our veterinary products—particularly
- medicinals—comply with all regulatory requirements and are successfully brought to market. Your responsibilities include regulatory submissions, lifecycle documentation, and collaboration with internal teams and external partners.

Key responsibilities:

• Prepare and maintain dossiers and applications for veterinary products (medicinal and
  - medicinal).
• Write and review sections of registration files according to project timelines.
• Respond to regulatory authority queries during and after registration.
• Collaborate with CDMOs and stakeholders to ensure data quality, safety, and efficacy.
• Manage documentation and coordinate lifecycle changes, including translations and artwork.
• Maintain knowledge of EU legislation and procedures.

Your qualifications:

• A degree in Pharmacy, Chemistry, Veterinary Sciences, or related scientific discipline.
• Experience with veterinary hygiene products, biocides, or complementary feed.
• Familiarity with veterinary medicinal product regulatory procedures (preferred).
• Strong communication and coordination skills across multiple regions.
• Proficiency in English; additional European languages are advantageous.

Join Animalcare and be part of a team dedicated to making a difference in animal health. To apply, send your CV and motivation letter in English via Linked
In or contact Maartje Kuijper by email.

Note: Due to high application volume, responses may be limited. Animalcare Group is an equal opportunity employer and values diversity.

Additional details:

• Seniority level: Entry level
• Employment type: Full-time
• Job function: Legal
• Industries: Pharmaceutical Manufacturing