Head Of Regulatory Affairs

Job Title: Head of Regulatory Affairs

Job Description

POSITION SUMMARY: We are seeking a Head of Regulatory Affairs to be based in Bridgewater, NJ. Reporting to the Chief Scientific Officer, this position will lead our regulatory submissions as well as preside over the company’s regulatory strategy. The position will lead the regulatory affairs and operations team, and partner closely with the R&D, Technical Operations, clinical development teams, and external consultants to advance the company’s portfolio and ensure commercial success.

The Head of Regulatory Affairs will be a key member of management and product development leadership teams. The successful candidate will help guide the strategic direction of the development programs and assure they are designed to meet regulatory approval standards on a US and global basis.

The Head of Regulatory Affairs will be a strategic, dynamic, highly collaborative, and successful senior executive who brings significant regulatory leadership experience, from product concept, through development programs, and marketed products.

The requirements for the position include a minimum of 10-15 years of regulatory affairs experience as a proven leader within the pharmaceutical/bio-pharmaceutical industry or as a seasoned regulator. The successful candidate will have a notable track record of regulatory leadership. They will not only have the ability to identify existing regulatory pathways but also help create, define, and implement new regulatory paths that will benefit all stakeholders.

Prior experience in successful filing of regulatory submissions is required, ideally including the use of 505(b)(1), 505(b)(2), and 505(j) regulatory pathways. Candidates should have experience negotiating, filing, and getting to approved registration with the FDA and Ex-US Regulatory Authorities. The successful candidate must have strong regulatory knowledge of drug development of sterile dosage products, including R&D, CMC/manufacturing upscaling, preclinical, and clinical requirements, post-marketing surveillance, quality, marketing, and sales. Pre-established relationships with the FDA and other regulatory agencies would also be ideal.

Hard Skills

Experience with 505(2)(b) registration pathway

Regulatory Strategy for product development

Correspond with global regulatory agencies – FDA, EU, China

Soft Skills

Strategic leadership

Dynamic and collaborative

Strong negotiation skills

About Actalent

Actalent 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 & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded 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

Ensuring growth opportunities for our people

The company is 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.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.