Senior Manager, Regulatory Affairs CMC

Senior Manager, Regulatory Affairs CMC

Biologics / Cell and Gene Therapy

Location:

Any EU location, US or Canada - home based

SRS are a global team of regulatory strategists from pharma, CRO and agency backgrounds, with expertise in drug development, regulatory strategy and operational implementation, CMC and quality assurance. We deliver global strategic regulatory consulting, dossier management services and GMP Quality services.

As the Senior Manager, Regulatory Affairs , you will be responsible for the oversight of the Strategic Regulatory Services (SRS) CMC team offering strategic, technical and regulatory global consulting to clients during drug development, marketing authorization (BLA) and product maintenance.

In this role you will support strategy for some clients to support registration (new and maintenance) within Biologics / Cell and Gene Therapy and be responsible for the strategic approach, facilitating issue resolution, ensuring project/program timelines/budgets are met.

Responsibilities and accountabilities:

• Serve as a resource for SRS team members and ICON colleagues, providing advice on project and Regulatory strategies.
• Utilize your technical knowledge of biologics development/manufacturing to act as a technical expert in CMC, providing technical and regulatory consulting to clients
• Provide support to multidisciplinary teams on the content, authoring and submission of a Biologics Licensing
• Application (BLA) or MAA and its regulatory review process in the life cycle management.
• Assist with the scientific writing and review of an IND/CTA application, BLA and evaluate conformance with the regulatory requirements.
• Continually monitor newly published FDA/EMA/ICH guidelines and other international guidance documents in the context of new and ongoing development programs. Provide training on applicable requirements to the teams as required.
• Manage, preparation and review of IND/CTA amendments, annual reports and other regulatory documents and their correspondences.
• Act as liaison between company and EMA/FDA other health authorities for assigned projects.
• Formulate regulatory strategy for Biologic products drawing on extensive regulatory expertise with a focus on innovation to support accelerated approval with minimum regulatory risks and compliance.
• Actively anticipate and develop initial or alternative development strategies, consulting with other resources within the organization as required.

Knowledge/Skills/Attributes

• Thorough working knowledge of local and global Health Authority regulations, guidelines, policies, GCP and GxP, ICH Guidelines
• Early stage development experience on biologics/gene therapy drugs, dealing with clinical trial submissions (IND, CTAs)
• Preferably experience in participation of FDA technical meetings
• Advanced degree (MSc., PhD., M.D., Pharm.D, MBA) in the biological, medical, chemical or engineering field may be beneficial.
• Circa10 years related experience in Regulatory Affairs in Pharma or CRO
• Circa 3-5 years experience of Biologics or Cell and Gene Therapy

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.