Senior Regulatory Affairs Officer (Hybrid or Remote)

Laboratórios BASI – Industria Farmacêutica S.A., in Mortágua (Viseu-Coimbra), seeks to integrate a new employee into its Regulatory team:

SENIOR REGULATORY AFFAIRS OFFICER (m/f)

Main Responsibilities:

- Manage the preparation and submission of MA variations for medicinal products (National, DCP and MRP procedures).

- Assess manufacturing, analytical and API changes, defining the appropriate regulatory strategy and documentation requirements.

- Review MA dossier documentation against manufacturing and analytical documentation, ensuring regulatory compliance and consistency.

- Coordinate the preparation and implementation of regulatory changes, working closely with Quality, Production, Planning, Purchasing, Market Access and Artwork teams.

- Review and update Product Information (SmPC, PIL and labelling) and provide regulatory support for Artwork.

- Interact with Regulatory Authorities, partners and customers, including the preparation of responses to deficiency letters and regulatory requests.

Profile:

- Degree or Master's degree in Pharmaceutical Sciences or another relevant scientific area.

- 5–7 years of experience in Regulatory Affairs, preferably in post-authorisation activities.

- Good knowledge of EU regulatory requirements, GMP and CMC documentation.

- Strong analytical, organisational and communication skills.

- Ability to work autonomously, manage priorities and coordinate cross-functional projects.

- Good command of English.

What We Offer:

- The opportunity to join a fast-growing company and an expanding business group, with a young, dynamic and multidisciplinary team.

- A stimulating and collaborative working environment, offering opportunities to contribute to the company's growth and development.

- The opportunity to work within an organisation with in-house manufacturing capabilities, providing close interaction with manufacturing, quality and regulatory processes.

- An attractive and competitive salary package, commensurate with the candidate's experience, skills and demonstrated expertise.

Work Model:

- Hybrid or fully remote, depending on experience and level of autonomy.

Interested?

Send your CV to: recrutamento@groupfhc.pt