We are seeking a Regulatory Affairs Specialist to support our regulatory activities and contribute to the success of our team.
This role is primarily focused on Regulatory Affairs, with additional exposure to Pharmacovigilance (PV) activities, offering a well-rounded opportunity across the product lifecycle.
As a Regulatory Affairs Specialist, you will play a crucial role in preparing, submitting, and managing regulatory documentation to ensure compliance with EU requirements. You will collaborate closely with cross-functional teams, including Pharmacovigilance, and maintain organized systems to drive efficiency and accuracy in regulatory and safety-related processes.
Key Responsibilities
- Regulatory Affairs (Primary Focus)
- Preparation, review, and submission of variations to Marketing Authorisations (MAs), including safety-related variations, in line with EU and national requirements.
- Oversee tracking and management of regulatory deadlines, ensuring proactive lifecycle management.
- Manage company licence variations in coordination with internal stakeholders and regulatory authorities.
- Contribute to and lead regulatory process design, optimisation, and documentation, including authoring and maintaining SOPs.
- Act as a point of contact for cross-functional projects impacting regulatory compliance, including audits, inspections, and quality management reviews.
- Maintain and improve internal tracking systems and regulatory processes.
- Pharmacovigilance (Supporting Role)
- Support assessment and implementation of safety-related regulatory changes (e.g. SmPC/PIL updates, RMP updates).
- Collaborate with PV teams to ensure alignment between regulatory submissions and safety data.
- Assist in tracking and implementation of commitments arising from PSURs, RMPs, and safety variations.
- Contribute to PV-related compliance activities.
- Support maintenance of PV agreements and regulatory-PV interfaces.
Job Requirements:
- Degree in Pharmacy, Life Sciences, or a related field.
- Minimum of 5 years’ experience in Regulatory Affairs within the pharmaceutical industry .
- Strong understanding of EU regulatory frameworks, including Variation Regulation, HMA/CMDh guidelines, and national requirements.
- Demonstrated experience in regulatory lifecycle management and safety variations.
- Exposure to Pharmacovigilance activities or willingness to develop PV knowledge.
- Ability to draft and implement procedures and internal workflows.
- Strong organisational and project management skills with attention to detail and a solutions-oriented mindset.
- Valid work permit.
What We Offer
- Competitive remuneration package
- Comprehensive health insurance
- Hybrid working arrangements
- Safe and conducive working environment
- On-the-job training and professional development in a state-of-the-art facility equipped with the latest technologies