Global Regulatory Affairs Lead (GRL), Remote

We are recruiting for an experienced Regulatory Affairs professional to join a major CRO in a client dedicated role - as a GRL for a successful biotechnology company.

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As a Global Regulatory Lead, you will be responsible for the development and execution of regulatory strategies, supporting the development of rare disease biological treatments (early stage to BLA/MAA).

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This is an exciting opportunity for a regulatory expert to play a pivotal role in advancing therapies that make a real difference in patients’ lives. The role will appeal to a well-rounded Regulatory professional who is willing to roll up their sleeves and take the lead on projects, gaining a variety of experiences with biologics (mAbs) in the US and the EU along the way. 

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Level

The ideal level for this role will be a Senior Manager or an Associate Director. This is a non-managerial role.

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Location

This is a permanent role that can be based remotely (home based) in a number of locations across Europe. Travel within Europe may be required once every few months.

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Responsibilities​

• Take ownership, develop and execute regulatory strategies for projects in development of rare disease biologics, focusing on the EU and the US markets.

• Lead and provide advice for the preparation, submission and management of clinical trial applications and related documents – CTA/IND, PIP/PSP, ODD etc. Review Protocols and ICFs. 

• Collaborate cross-functionally to ensure high-quality, on-time submissions, compliance and alignment with regulatory requirements and company objectives.

• Serve as the primary regulatory point of contact for Health Authorities (FDA, EMA).

• Stay updated on FDA and EMA regulatory developments and advice on their implications for current and future projects.

• May collaborate with other departments on aiding business development at the CRO, project forecasting and budgeting, participate in project review meetings and presentations.

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Requirements

• BSc in life sciences or a related field. Advanced degree or relevant certifications are a plus.

• 8+ years of Regulatory Affairs experience. Experience with biologics.

• Experience with IND submissions and FDA regulatory processes.

• Experience with ODDs and PIPs.

• Initial MAA/BLA experience is a plus.

• Sound knowledge of global regulatory guidelines.

• Sound judgement, creative problem solving and ability to perform independently with a solid sense of accountability.

• Fluency in English, with exceptional written and verbal communication skills for drafting, reviewing, and negotiating regulatory documents.

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What’s On Offer

• Join an established company that values innovation and offers personal and professional opportunities for growth.

• Flexibility that works for you – enjoy remote arrangements and flexibility on start/finish times.

• Competitive salary and benefits package.  

• Gain visibility and recognition in a high-impact role.

• Enhance your experience in cutting-edge biologics and life-changing rare disease treatments.

• Develop unique skill set in regulatory strategies for orphan drugs.

• Expand your understanding of the FDA regulatory process.

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Candidates must be authorised to work in the UK or the EU.

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Ant Talent - Who We Are​

We are a boutique recruitment agency working closely with select clients in the pharmaceutical industry, with a strong focus on Medical & Regulatory Affairs. We pride ourselves on identifying and recruiting the best professionals for our clients. Are you ready to take the next step in your career? We are looking for pioneers like you to help shape a healthier world for everyone. Rest assured, we’ll support you every step of the way.