Regulatory Affairs Specialist (M/F)

Tecnimede Group; Sintra; Presencial; EUR 35 000 - 55 000; Tempo integral

Resumo da oferta

A multinational pharmaceutical company is seeking a Regulatory Affairs Specialist to ensure compliance with regulations and prepare product registration dossiers. The ideal candidate should have a background in Pharmacy or Chemistry and proven experience in the pharmaceutical regulatory field. Strong communication skills and fluency in English are essential. This role offers a unique opportunity to make a significant impact within a dynamic team in Lisbon.

Qualificações

• Proven experience in the pharmaceutical regulatory area.
• In-depth knowledge of pharmaceutical legislation and regulations.

Responsabilidades

• Ensure compliance with applicable regulations and guidelines.
• Prepare and submit pharmaceutical product registration dossiers.
• Keep regulations updated and ensure company compliance.
• Collaborate with internal teams during pre-authorization and post-authorization.

Conhecimentos

Analytical skills

Problem-solving skills

Excellent verbal communication

Excellent written communication

Ability to work independently

Ability to work in a team

Fluency in English

Formação académica

Academic training in Pharmacy, Chemistry or related field

Descrição da oferta de emprego

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.

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