Head of Regulatory Affairs
16 hours ago
We are seeking a seasoned regulatory affairs professional to lead our regulatory submissions and develop our company's regulatory strategy.
This role will oversee the regulatory affairs and operations team, partnering closely with R&D, Technical Operations, and clinical development teams to advance our portfolio and ensure commercial success.
The successful candidate will have a strong track record of regulatory leadership, with experience in negotiating, filing, and obtaining approved registration with the FDA and Ex-US Regulatory Authorities.
Key responsibilities include:
- Developing and implementing regulatory strategies for product development
- Corresponding with global regulatory agencies, including the FDA, EU, and China
- Leading the regulatory affairs and operations team
- Partnering with R&D, Technical Operations, and clinical development teams
The ideal candidate will have a minimum of 10-15 years of regulatory affairs experience, with a strong understanding of drug development, including R&D, CMC/manufacturing upscaling, preclinical, and clinical requirements.
Pre-established relationships with the FDA and other regulatory agencies are a plus.
About ActalentActalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation, and speed to market.
With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people.
We embed DE&I into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
We are an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information, or any characteristic protected by law.
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