Regulatory Affairs Specialist – Pharmaceutical – Brussels

Title: Regulatory Affairs Specialist

Reporting To: Quality and Regulatory Director

Industry: Life Sciences – Pharmaceutical

Salary: Negotiable – depends on experience

Location: Brussels

At Darwin Recruitment, we are proud to be partnered with a leading pharmaceutical company who are at the forefront of pharmaceutical innovation, dedicated to improving patient health worldwide. Their commitment to excellence and compliance with global regulatory standards ensures that our products meet the highest quality and safety requirements. As we continue to support their efforts to expand their global footprint, we are seeking a Senior Regulatory Affairs Specialist to join the RA team in Belgium.

Position Overview:

We are looking for a highly skilled and experienced Senior Regulatory Affairs Specialist to lead and manage regulatory activities for their pharmaceutical products. This role is essential in ensuring that the products meet all regulatory requirements and are successfully brought to market in a timely manner.

Your Responsibilities:

Your responsibilities include but not limited to the following:

• Regulatory Strategy: Develop and implement regulatory strategies for new product development and lifecycle management, ensuring alignment with global and regional regulatory requirements.
• Regulatory Submissions: Prepare, compile, and submit regulatory dossiers for new drug applications, variations, renewals, and other regulatory filings to health authorities such as EMA and national agencies.
• Regulatory Compliance: Ensure that all products comply with EU and international regulations, including ICH guidelines, GMP, and other relevant standards.
• Health Authority Interactions: Serve as the primary point of contact with regulatory agencies, coordinating meetings, and responding to inquiries in a timely and professional manner.
• Labeling and Documentation: Review and approve product labeling, packaging, and promotional materials to ensure compliance with regulatory requirements.
• Regulatory Intelligence: Monitor and interpret regulatory changes and trends in the pharmaceutical industry, providing strategic advice to internal teams on potential impact and necessary actions.

Your Qualifications:

• Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biochemistry, or a related field.
• 5 years of industry experience in a similar Regulatory Affairs role
• Knowledge of EU and International Regulations
• Experience with submissions to a range of global bodies
• Fluent in English with French or Dutch an advantage

Please apply or email james.allen@darwinrecruitment.com for more information.

Darwin Recruitment is acting as an Employment Agency in relation to this vacancy.

James Allen