Senior Regulatory Affairs Manager

Senior Regulatory Affairs Manager focuses on ensure company’s regulatory affairs activities are conducted according to relevant regulations,laws, and standards.

What the role involves

• Ensure company’s regulatory affairs activities are conducted according to relevant regulations,laws, and standards.
• Overseeing the company’s regulatory application process to obtain all necessary permits, licenses, certificates, authorizations, etc.
• Maintain good relationship with regulatory authorities, trade associations and internal stakeholders.
• Ensure appropriate basis to marketing strategies are identified and/or implemented.
• Provide advisory to company’s management on emerging regulations and developments in industry, particularly in the field of medicinal products and medical devices.
• Managing a team of regulatory affairs professionals.

Skills and requirements

• A scientific degree in a pharmaceutical, chemical or biological discipline.
• 8 years Regulatory Affairs, ideally within UK OTC including Post Marketing Licence Maintenance activities, renewals and safety updates.
• Must have leadership experience, and strong experience in medicinal products.
• Experience from launching new products and interactions with PAGB and ClearCast.

Confirmed role details

• We believe our people are our greatest asset.
• Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supporte.
• Hybrid Working Approach.
• We love our offices and the setting they provide for in-person collaboration and celebration.

Additional role context

• Assists in identification of advanced regulatory strategies for all regulatory classifications, with focus on medicinal products and medical devices.