Senior Manager, Regulatory Affairs

United Kingdom- Remote or Hybrid (Reading, Swansea)

At ICON, it’s our people that set us apart.

As a global provider of drug development solutions, our work is serious business. But that doesn’t mean you can’t have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?

The Role:

We are looking for passionate, resilient, and inspiring individuals to join our team. As the Sr Regulatory Affairs Manager, you will represent the Regulatory Affairs function on project teams and client meetings to provide regulatory guidance and strategy.

Job Description Summary:

• Participate in provision of Regulatory expertise in strategic drug development across multiple areas.

• Take part in preparation of strategic development and submission plans.

• Be involved in the regulatory affairs activities across the ICON portfolio and be an expert and advisor to ICON clients (externally and Internally)

• Be a trusted partner - represent the Regulatory Affairs Department in business development activities and generate new business opportunities

• Contribute to at least two of the following areas: Interactions with Regulatory agencies, early phase consulting, Development Planning (PDP/RDP/CDP), Scientific/Agency advise, orphan drugs/pediatric development, medical devices, Reg Intelligence, due diligence, strategic CT support/GCP compliance, biologlcal/blotech/biosimilars, small company support (incl. SOPs development etc.)

• As Regulatory Expert, build effective teams and Involve junior members of the team into more complex regulatory issues. Mentor and train across function to support the wider Regulatory Department.

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• Attention to detail: Identifies and resolves discrepancies across various source documents, including published and unpublished documents.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

What you need

• Minimum of a Bachelor’s degree in Regulatory/Life Sciences

• Strong background and Regulatory experience in Pharma, Biotech, or related industry with emphasis on US Regulatory Affairs

• Knowledge of IND/NDA/BLA requirements

• Experience liaising with the FDA and conducting meetings to resolve any issues/concerns

• Comfortable being in an advisory based position to present, meet client requirements and a precise, professional and personable approach.

• Experience supporting client development activities and people management.

• Experience in Gene Therapy preferred

• Sound knowledge of the life cycle of a drug development program

Why join us?

Ongoing development is vital to us, and as the Sr Regulatory Affairs Manager, you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. Our benefits package is competitive, our scope is international and we genuinely care about our people and their success.

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