Regulatory Affairs Specialist (M/F) Sintra

Regulatory Affairs Specialist (M/F)
Sintra
Sintra, Lisboa, Portugal

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
- authorization phase (pharmaceutical, analytical and clinical development, and quality) and in the
- 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
- solving skills.

- Excellent verbal and written communication skills.

- Ability to work independently and in a team

- Fluency in English.

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