Location: European Union – Homebased
Schedule: Permanent

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Regulatory Affairs Principal Strategist - Clinical Operations on a permanent basis with REMOTE option in EU. You will will be responsible for developing and implementing regulatory submission strategies for the European Union region, while working on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device and consumer health companies.

Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!

Main Job Tasks and Responsibilities:

The EU Regulatory Strategy Lead will be responsible for developing and implementing regulatory submission strategies for the European Union region. This role involves leading regulatory activities, ensuring compliance with EU regulations, and collaborating with global teams to support regulatory submission management and study start up activities.

Key Responsibilities:

• Lead and manage all EU regulatory submission activities, including planning, authoring, reviewing, and coordinating submissions.
• Ensure compliance with EU regulatory requirements and guidelines.
• Represent the EU region in global regulatory strategy discussions and provide regional strategic expertise.
• Manage interactions with EU regulatory authorities in support of clinical trials.
• Provide strategic input into EU clinical trial submissions, including protocol and Investigator’s Brochure (IB) review and Request for Information (RFI) management.
• Collaborate with cross-functional teams, to ensure regulatory alignment and support product clinical trial development.
• Monitor and interpret EU regulatory environment changes and communicate their impact on regulatory strategies.
• Ensures regulatory contributions, achieve the objectives in the strategy, achieve agreed standards, maximizing overall project delivery time and probability of success and facilitating EU submission activities.

Education and Experience:

• Bachelor’s degree in a scientific discipline (e.g., Life Sciences, Pharmacy, Biotechnology) or equivalent; advanced degree preferred.
• Minimum of 8 years of regulatory experience in the pharmaceutical or biotechnology industry, with a focus on the EU region.
• Extensive knowledge of EU regulatory submission and approval processes.
• Significant experience with the EU CTIS portal.
• Proven ability to manage regulatory submissions.
• Strong communication and leadership skills.

Specific Role Requirements and Skills:

• Experience with global regulatory submissions and health authority interactions.
• Ability to manage multiple projects in a fast-paced environment.
• Strong problem-solving and decision-making abilities.
• Previous experience as a national and/or regional regulatory liaison for a product in the clinical development phase.
• Knowledge of drug development practice rules, regulations and guidelines - Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines.
• Ability to communicate complex information and analyses to a variety of stakeholders in both verbal and written format.

Our Benefits:

• Excellent work-life balance
• Dedicated Line Manager
• Monthly meetings with line manager
• Full performance and development process with end of year reviews
• Team events and end of year party
• Career opportunities within in ClinChoice, locally and globally
• Employee satisfaction survey - your feedback is important for continuous improvement

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!

Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Regulatory affairs, Clinical operations, CTIS, Pharma, Biotech, Regulatory submissions.

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