Director of Regulatory Affairs (US Based)
Intrinsik Health Sciences Inc., is a privately owned North American consulting firm focusing on the regulatory and toxicology challenges associated with the development of new products (pharmaceuticals, biologics, medical devices, consumer products, natural health products and cosmetics). We are continuing to grow, and will always welcome candidates with strong scientific skills, creativity and enthusiasm to join our team.
Intrinsik has an immediate opening for a Director of Regulatory Affairs at a US location which is still to be determined (we are willing to be flexible depending on the successful candidate’s preference). We aim to offer our employees an environment that encourages professionalism, creativity, independence and continuous learning. The assets of any knowledge-based company are its people, and we believe strongly in investing in those assets by offering training and mentoring of our staff. Like all successful organizations, we are committed to growing and advancing our employees’ careers by providing them with new responsibilities and opportunities within the company.
The position involves strategic oversight of regulatory projects related to Investigational New Drug applications and New Drug Applications to the US Food and Drug Administration. The position will report to the Vice President of Regulatory Affairs, and will initially have one direct report with the potential for significant geographical expansion. Additional operational resources to support US regulatory activities are available at our Canadian head office. The Director of Regulatory Affairs will be responsible for providing strategic advice on drug development to Intrinsik’s clients, as well as handling direct contact with FDA on their behalf. The successful candidate must be able to provide leadership, mentor staff, develop and execute strategy, and be able to generate submission content i.e., review and, if necessary, author scientific documents for use in regulatory submissions. Opportunities for growth include expansion of of the US regulatory business, and/or expansion into new business areas.
- Leadership role in the development of regulatory strategies to support conduct of clinical trials and applications to market new drugs in the US.
- US representative for Intrinsik and its clients in interactions with FDA including, but not limited to, Pre-IND, EOP2, Pre-NDA meetings, and IND and NDA applications.
- Critical assessment of data and documents to support the above activities, and where necessary authoring of content for regulatory submissions, regulatory strategy documents and other reports for Intrinsik’s clients.
- Management of a portfolio of Intrinsik’s clients; this involves direct contact with the client, and management of not only scientific and regulatory aspects, but also business aspects such as contracts and budgets.
The successful applicant(s) would ideally have the following qualifications:
- Minimum BSc in Life Sciences. Advanced degree a distinct advantage.
- 10 - 15 years of hands on experience in US regulatory affairs, with personal responsibility for direct interaction and negotiation with FDA.
- At least 5 years must have been spent at management level, preferably senior management.
- Clinical background (rather than CMC) an advantage
- Candidates MUST have experience in the preparation and maintenance of INDs from Preclinical to Phase 3.
- Experience with the filing and maintenance of NDAs.
- Solid understanding of regulatory processes and the overall drug development process.
- Excellent working knowledge of US regulations, guidance and policy.
Intrinsik is also seeking excellence in the following attributes:
- Ability to develop creative solutions to issues and problems
- Ability to multi-task and coordinate project activities to achieve goals on time
- Negotiation skills
- Interpersonal skills, with the ability to work well in a team, whether internal to Intrinsik or with clients.
- Attention to detail
- Written and spoken communication.
- Computer skills, particularly MS Word and Adobe Acrobat and eCTD software
Interested candidates may submit their resumes via email to Andrea Kalentizis , Human Resources Manager, at