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

MMS Holdings Inc; Madrid; Presencial; EUR 70.000 - 120.000; Jornada completa

Descripción de la vacante

A leading clinical research organization seeks a Principal Regulatory Strategist to consult on complex regulatory issues. The role requires significant experience in Regulatory Affairs and offers the chance to shape regulatory strategies for pharmaceutical and biotech projects, working in a supportive, innovative environment. Join a recognized company that values contributions and fosters career advancement.

Formación

• 15+ years experience in Regulatory Affairs or Strategy.
• Expert knowledge of scientific principles.
• Hands-on experience with clinical trial and pharmaceutical development preferred.

Responsabilidades

• Provide consulting and advisory services for regulatory issues.
• Author and maintain regulatory compliance documentation.
• Conduct regulatory intelligence gathering to support project development.

Conocimientos

Problem-solving

Communication

Organizational skills

Educación

Masters or PhD in Biological Science, Public Health, or Regulatory Science

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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