Planet Pharma
EU Regulatory Affairs Specialist
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EU Regulatory Affairs Specialist
Take the lead at a pivotal moment in European pharmaceutical development! We are seeking a highly skilled and motivated EU Regulatory Affairs Specialist to join an innovative team during a critical phase of a groundbreaking medicinal product in a rare paediatric disease. This is a fantastic opportunity to influence the regulatory strategy of a late-stage product, working remotely with flexibility, while engaging in impactful projects from the outset. If you have a proven track record in MAA filings, orphan drug experience, and strong EMA interactions, this role is perfect for you.
Key Responsibilities
- Collaborate with the EU and global regulatory teams to define strategic pathways, ensuring an above-market approach.
- Oversee the preparation, submission, and management of regulatory filings such as CTAs, PIPs, scientific advice, MAAs, and variations.
- Lead the EU regulatory strategy during key development milestones, contributing to health authority interactions.
- Monitor EMA and national authority activities, assessing their impact on project timelines and strategies.
- Develop and review EU product information, representing regulatory perspectives at global meetings.
- Proactively identify and mitigate regulatory risks, ensuring compliance with all relevant guidelines and regulations.
- Support post-approval activities, maintaining regulatory submissions and variations as necessary.
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Required Skills
- Bachelor's degree in Life Sciences or related discipline.
- Minimum of 6 years’ experience in pharmaceutical or biotech regulatory affairs, with significant hands-on involvement in EMA filings.
- Proven success in preparing and submitting EU Marketing Authorization Applications and managing direct interactions with EMA.
- Extensive knowledge of the European regulatory landscape, especially within rare diseases, orphan drugs, and paediatric development.
- Exceptional leadership, strategic thinking, and innovative problem-solving abilities.
- Strong verbal and written communication skills, capable of working effectively within global, cross-functional teams.
- Ability to interpret complex data collaboratively with subject matter experts.
- Experience working extensively with EMA, including scientific advice meetings and post-approval activities.
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Nice To Have Skills
- Prior experience in paediatric or rare disease drug development.
- Knowledge of additional global regulatory agencies.
- Fluency in other European languages.
- Experience with early-phase clinical development or lifecycle management strategies.
Preferred Education And Experience
- Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
- At least 6 years of regulatory affairs experience within the pharmaceutical or biotech industry.
- Specific experience preparing MAA submissions for rare or orphan products.
- Prior involvement in late-stage or conditional marketing authorizations.
Other Requirements
- Fully remote working flexibility; occasional office visits are advantageous.
- Ready to start ASAP, ideally in August.
- Please note, this is a 12-month contract with an initial focus on maternity cover and increased workload due to upcoming submissions.
Ready to make a tangible impact in a dynamic environment? Apply now to contribute your expertise to a life-changing project and advance your career in regulatory affairs!
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