Principal Regulatory Strategist (CRO / Pharma Industry) - Europe Regulatory Affairs - Regulator[...]

MMS Holdings Inc; Madrid; Presencial; EUR 70.000 - 100.000; Jornada completa

Descripción de la vacante

MMS Holdings Inc, a leading clinical research organization, seeks a Principal Regulatory Strategist to provide consulting for complex regulatory issues. This full-time remote role requires extensive experience in Regulatory Affairs, encompassing project advisory, compliance, and regulatory intelligence. Ideal candidates will possess a strong educational background and proven leadership in the regulatory field, ready to contribute to a culture that values innovation and collaboration.

Formación

• Minimum 15 years' experience required in Regulatory Affairs or Strategy.
• Reputation as an emerging leader in the field with sustained performance is essential.
• Basic understanding of CROs and the drug development process.

Responsabilidades

• Provide consulting and advisory services for complex regulatory projects.
• Conduct regulatory intelligence gathering and maintain documentation for compliance.
• Participate on project teams, offering expertise on regulatory matters.

Conocimientos

Regulatory Affairs

Scientific Principles

Communication

Problem-Solving

Organizational Skills

Educación

College degree in Biological Science, Public Health, or Regulatory Science

Masters or PhD preferred

Herramientas

MS Office

Descripción del empleo

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 a 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 best 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 not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

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

This would be 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 as required to sustain 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 intelligence reports.
• Participate on project teams and provide expertise on related regulatory matters.
• Clearly and accurately conveys information to peers, supervisors, and other stakeholders.
• Participates in in implementation of new / updated operational strategies to comply with new / updated policies and recommendations.
• Identifies new / updated policies and recommendations and may provide professional opinions on impact of regulatory changes to MMS and Clients (from the desk of, blogs, webinars, etc.).

Requirements

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

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