Director, Regulatory Affairs - (Biologics)

Director, Regulatory Affairs

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

Due to a number of exciting new projects being awarded to ICON, we are seeking to expand our team and expertise, with the recruitment of a Director of Regulatory Affairs within our US team. We are looking for passionate, resilient, and inspiring individuals 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. We deliver global strategic regulatory consulting, dossier management services and GMP Quality services

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.

In this role, you will be responsible for regulatory strategy for a combination of current and prospective clients in the US for drugs and biologics. As a senior member of the SRS team, you will further be responsible for the strategic approach and client interactions necessary to securing new and repeat business, facilitating issue resolution and ensuring project/program timelines/budgets are met. You will also maintain client relationships in the support of future business as the position participates in business development activities.

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 e.g. DCT, COVID-19, GMO, ATMP development, Cell and Gene therapy etc.

• 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 for PIP, OD, SME, MAA and post-licensing activities as applicable.

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

• Conceptualize and draft complete proposals based on a client idea or (Request for Proposal (RFP) including Independent development of project plans and scientific content for clients. Achieve a good conversion rate of submitted to won proposals.

• Act as scientific thought partner with the client and the project team throughout the project.

• May lead a team

Knowledge/Skills/Attributes

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

• Experience with small molecules, biologics, gene therapy and cell therapies.

• Post market support experience

• 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

• Planning and organization: Plans work effectively to meet goals and ensure timely completion of assignments. Manages time effectively.

• Attention to detail: Identifies and resolves discrepancies across various source documents, including published and unpublished documents. Notes and resolves errors in written documentation

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

• Experience in regulatory writing, meeting packages, dossiers

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 12-15 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.