Regulatory Affairs Specialist

Tecnimede Group is a Portuguese multinational company, with more than 40 years of history in the life cycle of the drug product for human use - development, production, promotion and marketing - with the mission to improve and preserve the human life and the human health.

Exporting to more than 100 countries worldwide, it is present in 6 countries (Portugal, Spain, Italy, Marocco, Columbia and Brazil) with strong focus in expanding internationally and building strategic partnerships.

We are looking to reinforce our team with a Regulatory Affairs Specialist (M/F) .

Responsibilities

- Ensure the coordination of all activities related to the regulatory area, ensuring compliance with applicable regulations and guidelines;

- Prepare and submit pharmaceutical product registration dossiers for approval by authorities;

- Keep up to date with changes in regulations and guidelines and ensure the company is compliant;

- Collaborate with internal teams in the pre-authorization phase (pharmaceutical, analytical and clinical development, and quality) and in the post-authorization phase (industrial production, pharmacovigilance, logistics, price and reimbursement and quality);

- Participate in audits and inspections, providing support and necessary information;

- Develop and update locally controlled regulatory documentation (SOP’s, training materials), ensuring they are updated and proactively identify procedural gaps to implement solutions in collaboration with all relevant stakeholders.

Requirements

- Academic training in Pharmacy, Chemistry or a related field;

- Proven experience in the pharmaceutical regulatory area;

- In-depth knowledge of pharmaceutical legislation and regulations;

- Analytical and problem-solving skills;

- Excellent verbal and written communication skills;

- Ability to work independently and in a team;

- Fluency in English.

In accordance with the provisions of the GDPR and other legislation in force on personal data protection, the contracting company guarantees that the processing of your personal data is lawful, fair, transparent, and limited to the purposes for which your data was collected.

Regulatory Affairs Manager

We're currently partnering with a leading global consumer health business to find an experienced Global Regulatory Operations Medicine Manager to join their dynamic Regulatory Affairs team.

This is an exciting opportunity to lead end‑to‑end regulatory operations across a diverse portfolio of over‑the‑counter (OTC) and consumer health products. You’ll be working at the heart of a fast‑paced, innovation‑driven environment, driving dossier strategy, managing global submissions, and collaborating closely with cross‑functional teams across markets.

Responsibilities

- Lead Regulatory Submissions: Oversee the planning, preparation, and timely submission of regulatory documentation (e.g., eCTD Modules 1–5) for product registrations, variations, renewals, and withdrawals, ensuring accuracy and compliance.

- Coordinate Stakeholder Engagement: Serve as the primary regulatory contact for designated product categories (e.g., analgesics), fostering effective communication with internal teams and external partners.

- Maintain Dossier Integrity: Manage the creation and upkeep of core product dossiers, ensuring alignment with current regulatory requirements and submission timelines.

- Ensure Documentation Readiness: Supervise the organisation and electronic archiving of regulatory records to support accessibility and inspection readiness.

- Collaborate Across Functions: Work cross‑functionally with Regulatory Strategy, R&D, Pharmacovigilance, Quality, and Marketing to ensure regulatory alignment throughout the product lifecycle.

Requirements

- Degree in Pharmacy, Life Sciences, or a closely related field (Bachelor’s or Master’s level).

- At least 5 years of hands‑on experience in regulatory affairs within the pharmaceutical or healthcare sector.

- Strong command of international regulatory guidelines (e.g., EMA, ICH, and national health authorities).

- Solid track record in preparing and submitting eCTD dossiers, including CMC M3 content development.

- Highly organised with excellent attention to detail and ability to manage multiple regulatory projects simultaneously.

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