Director, Regulatory Affairs - CMC/Biologics

Director, Regulatory Affairs CMC

Location

The position may be remote based across the US, or East Coast preferred

The Role

As a Director in CMC Regulatory Affairs, you will provide expert knowledge on exciting area of small and large molecules within the Global Regulatory Affairs, CMC team which forms part of our Regulatory Consulting Services Group.

The department is growing and there are excellent prospects for professional development and enhancing your skills. With a variety of new projects, we are looking to enhance the knowledge within our team with the addition of this hire. Activities encompass early and late stage drug development, marketing application and approval, and product maintenance.

We are seeking individuals with experience in technical development, testing, and manufacturing of small and large molecules (Biologics [mAb, bSAb & Recombinant Protein, RNA, mRNA, SiRNA], Biosimilars, CGT, ADC & Vaccines), Peptides and Radiopharmaceuticals in particular with CMC experience.

Responsibilities

• Serve as a technical expert in development, testing and manufacturing of Biologics and resource to ICON colleagues, and clients providing advice

• Effectively manage the preparation of regulatory CMC submission documents for INDs/NDAs/BLAs/NDSs/ANDAs and Post approval supplements

• Facilitate submission approvals and amendments through leading communications and negotiations with client, government agencies, and project teams.

• Actively anticipate and develop initial or alternative regulatory strategies, consulting with other resources within the organization as required.

• Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise.

• Enthusiastically monitors for new regulatory requirements and shares key findings.

• Lead and/or participate in the preparation of quotations for projects that may cross multiple service areas within the company and manage projects within budget, preparing change orders as needed.

• Experience in US FDA Drug listing (NDC) process, Drug establishment Registrations, Lot Distribution Reports

• Serve as US Agent for client submissions and act as interface with local agency and sponsor

• Support right from preclinical to post approval activities for client submissions.

Education/Experience

• Bachelors degree in a relevant discipline, preferably in a 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.

• Relevant experience i.e. pharmaceutical, biologics with regulatory experience in the global environment (e.g. US, EU, Canada).

• Technical development, testing and manufacturing of wide range of dosage forms

• Demonstrable experience in a regulatory CMC role or in the delivery of regulatory CMC strategy and documentation during drug development and/or product maintenance.

• Experience supporting business development activities and people management an asset.

• Certification in regulatory affairs (RAC) or post-secondary institution beneficial.

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