Director Regulatory Affairs (Biologics/Cell Therapy)

Director, Regulatory Affairs

Location: Any location in the US. Remote or Office based.

We are seeking to expand our team and expertise, with the recruitment of a Director of Regulatory Affairs to join our Strategic Regulatory Affairs (SRS) team. SRS are a global team of regulatory strategists from pharma, CRO and agency backgrounds, with expertise in drug development, regulatory strategy and operational implementation.

As a Director, Regulatory Affairs, you will create a culture of, process improvement with a focus on streamlining our processes, adding value to our business and meeting client needs. Representing ICON as a Subject Matter Expert for Regulatory Affairs in the US market you will proactively communicate objectives and results with clients offering strategic regulatory advice.

Responsibilities and accountabilities:

• Actively anticipate, develop and implement initial or alternative regulatory strategies for contracted clients.

• Act as scientific thought leader for ICON. Support initiatives to ensure ICON is at the leading edge of new regulatory developments.

• Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise, consulting with other resources within the organization as required.

• Manage workflow including prioritizing project objectives, and establishing timeframes for projects with clients and managing client contracts.

• Effectively prioritize and complete multiple projects within established timeframes and within budget

• Train, coach, and develop assigned individuals to build overall team expertise

• Develop and implement strategies and regulatory submissions.

• Leading FDA pre -IND, End of Phase 2 and Pre NDA/BLA meetings with FDA.

• Supporting post marketing activites

• Function as primary liaison with FDA for designated projects and designated clients

• May lead a team

Knowledge/Skills/Attributes

• Experience with in one of the following; small molecules, biologics, gene therapy and cell therapies.

• Excellent verbal and written communication: Conveys thoughts in a clear, concise, and accurate manner. Uses appropriate regulatory, medical, and scientific nomenclature. Listens carefully and asks questions when necessary to ensure understanding

• Experience in client interaction and/or in a consulting environment is advantageous

• Experience of leading FDA submissions

Education/ Experience:

• Bachelor's degree in a relevant discipline, preferably in life sciences, or other healthcare field.

• Advanced degree (MSc., PhD., M.D., Pharm.D, MBA) in the biological, medical, chemical or engineering field may be beneficial.

• Minimum of 10 years related experience in Regulatory Affairs setting, in Pharma or CRO, with emphasis on US Regulatory Affairs

• Experience supporting client development activities and people management.

Benefits of Working in ICON:
Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.