Principal Regulatory Strategist CROPharma Industry - Europe

MMS; Berlin; Remote; EUR 80.000 - 120.000; Vollzeit

Zusammenfassung

Join a forward-thinking organization that is shaping the future of clinical research. This full-time consultancy role offers the opportunity to work remotely while providing expert regulatory strategy and advisory services. With a strong focus on collaboration and innovation, you'll be part of a team dedicated to overcoming complex regulatory challenges in the pharmaceutical and medical device industries. If you have a passion for regulatory affairs and a proven track record in the field, this is your chance to make a significant impact in a supportive and dynamic environment.

Qualifikationen

• 15+ years in Regulatory Affairs or Strategy with expertise in Marketing Applications.
• Strong knowledge of scientific principles and proven leadership in the field.

Aufgaben

• Provide consulting services for complex regulatory issues and maintain compliance documentation.
• Conduct regulatory intelligence and participate in project teams to support regulatory matters.

Kenntnisse

Regulatory Affairs

Communication Skills

Problem-Solving Skills

Organizational Skills

Leadership

Ausbildung

Bachelor in Biological Science

Masters or PhD in Regulatory Science

Tools

MS Office

Jobbeschreibung

Are you looking to join a company where your contributions truly matter and where you'll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry-leading employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains an industry-leading customer satisfaction rating and fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.

This is a full-time consultancy role working remotely.

Principal Regulatory Strategist

Responsibilities

• Provide consulting and advisory services for complex regulatory issues or projects.
• Author and maintain documentation required for regulatory compliance.
• Provide senior technical review for complex regulatory projects.
• Conduct regulatory intelligence gathering to support development of regulatory roadmaps, complex feasibility assessments, and other regulatory reports.
• Participate in project teams and provide expertise on regulatory matters.
• Convey information clearly and accurately to peers, supervisors, and stakeholders.
• Implement new or updated operational strategies to comply with policies and recommendations.
• Identify new or updated policies and recommendations and provide professional opinions on their impact on MMS and clients (via blogs, webinars, etc.).

Requirements

• College graduate in Biological Science, Public Health, Regulatory Science, or a related field; Masters or PhD preferred.
• Minimum of 15 years of experience in Regulatory Affairs, Strategy, or a similar field, including experience with Marketing Applications (EMA).
• Expert knowledge of scientific principles and concepts.
• Reputation as an emerging leader in the field with sustained performance and accomplishments.
• Proficiency with MS Office applications.
• Hands-on experience with clinical trials and pharmaceutical development preferred.
• Good communication skills and willingness to collaborate to understand needs and solve problems.
• Excellent problem-solving skills.
• Good organizational and communication skills.
• Basic understanding of CROs, scientific and clinical data/terminology, and the drug development process.

Required Experience: Senior IC

Key Skills

Facilities Management, Attorney, Computing, Cardiovascular, Account Opening, Analytics