Proclinical Staffing
Regulatory Affairs Specialist
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Are you ready to shape EU and global regulatory strategies that bring innovative analgesics and anaesthetics to market?
Proclinical is seeking a Regulatory Affairs Specialist to join a dynamic team in the UK. This role focuses on EU and global regulatory strategies within the pharmaceutical industry, particularly in analgesics and anaesthetics. You will play a key role in managing regulatory submissions, ensuring compliance with applicable regulations, and contributing to the development and lifecycle of pharmaceutical products.
Responsibilities:
- Collaborate with EU and Global Regulatory Leads to define and implement regulatory strategies for assigned projects.
- Oversee the preparation, submission, and management of regulatory filings, including CTAs, PIPs, scientific advice, MAAs, and variations.
- Identify and assess regulatory risks, developing strategies to mitigate them effectively.
- Support the development of EU product information and represent EU regulatory strategy in global labeling team meetings.
- Monitor and analyze EMA and national Health Authority activities, assessing their impact on projects.
- Foster positive interactions with the EMA and represent the department in EU project teams, committees, and external meetings.
- Ensure compliance with relevant regulatory requirements, company policies, and industry standards.
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Key Skills and Requirements:
- A degree in Life Sciences or a related discipline.
- Proven experience in the pharmaceutical or biotechnology industry, with a strong background in regulatory affairs strategy.
- Hands-on experience with major regulatory filings, including EU Marketing Authorisation Applications (MAAs) and direct interactions with EMA and Health Authorities.
- Strong leadership and communication skills, with the ability to collaborate effectively across functions and organizational levels.
- Strategic thinking and problem-solving abilities, with a proactive approach to identifying and mitigating regulatory risks.
- Expertise in the current regulatory landscape and evolving guidelines.
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If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@proclinical.com.
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If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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