Program Director
il y a 4 jours
The Program Director of Regulatory Affairs will spearhead the development, planning, and execution of regulatory programs for our diverse portfolio. This role will involve close collaboration with cross-functional teams, including clinical, quality, and product development, as well as external regulatory agencies. The successful candidate will play a pivotal role in aligning our regulatory strategy with our overall business objectives, supporting product lifecycle management, and facilitating market access.
Key Responsibilities
- Strategic Leadership: Develop and execute regulatory strategies to ensure compliance across all products and markets, anticipating and addressing regulatory challenges.
- Programme Management: Lead and manage a portfolio of regulatory projects from inception to completion, ensuring timely submission of documentation and securing approvals.
- Stakeholder Collaboration: Work closely with internal teams and external regulatory bodies to communicate regulatory requirements and align on submission strategies.
- Policy & Compliance: Keep updated with global regulatory requirements and trends, interpreting regulatory guidance to implement best practices and ensure compliant processes.
- Risk Management: Identify potential regulatory risks and develop mitigation strategies, advising senior leadership on regulatory impact.
- Team Development: Mentor and develop a high-performing team, providing guidance and support for individual growth and team cohesion.
Qualifications and Experience
- Education: Bachelor’s degree in Life Sciences, Regulatory Affairs, or a related field; advanced degree preferred (MSc, PhD, or equivalent).
- Experience: 15+ years in Regulatory Affairs within [industry, e.g., pharma, biotech, medtech], with a proven track record of regulatory submissions and approvals. At least 5 years in a leadership role, preferably with Global exposure.
- Regulatory Knowledge: Strong understanding of FDA, EMA, and other relevant regulatory bodies; deep familiarity with industry standards and guidance documents.
- Project Management: Exceptional organizational skills with experience in managing multiple large-scale projects simultaneously.
- Interpersonal Skills: Excellent communication and negotiation skills, with an ability to work effectively across levels and departments.
- Analytical Mindset: Strong problem-solving skills, capable of making strategic decisions and influencing organizational direction.
- Professional Certification: RAC or similar Regulatory Affairs certification is highly desirable.
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