Job Description

We are looking for a highly motivated, strategic and collaborative regulatory CMC professional with experience of working   on biological products in various phases of development, who is experienced in, and enjoys the challenges of team leadership and people management.

Our client is a Blue-chip global Biotech company with a strong portfolio of development and marketed biologicals across multiple modalities, therapy areas and formulations.  They have a strong pipeline, so projects are varied, and your input will be broad and in-depth.  The role is based at the Global HQ in New Jersey.

As Global Regulatory Affairs (Bio), Director of CMC you will lead and oversee a team of Regulatory CMC professionals at Snr Manager and Associate Director grade, ensuring the appropriate submission strategies are developed and followed, whilst mentoring and showing leadership to your team

You will be required to show your proven ability to effectively manage people, time and    multiple projects and have hands-on experience in biologics from early phases through commercialization. You will also have a clear and concise communication style with experience(s) in people leadership and direct people management.

Responsibilities:

• Lead, manage, mentor organize a team (up to 6) Regulatory CMC Snr Managers and Associate Directors
• Lead content development, compilation and review of the Quality Module for IND, CTA and BLA/MAA submissions
• Provide leadership within cross functional teams on regulatory issues as they arise throughout the entire life cycle of the product.
• Lead matrix teams and manage all authoring and responses to agency questions for complex post approval submissions worldwide based on FDA, EMA, ICH guidelines and other Health Authority guidelines
• Lead Agency meeting package preparation and submission and prepare teams for meetings with agencies.

Requirements:

• BA/BS degree in life sciences in chemistry, molecular biology, or similar is required, an advanced degree is preferred. RAC certification desirable but not mandatory.
• At least 10 years of experience in Regulatory Affairs CMC in the pharmaceutical and/or biotechnology industry.
• Prior success filing clinical trial applications, marketing applications, amendments, supplements, and variations for drugs (biologics) within timelines is required; global submission experience and/or knowledge of global regulations/requirements, e.g., APAC/LatAm, is a desired plus.
• Thorough understanding of relevant drug development regulations and guidelines is essential to support programs during development and commercial lifecycle. Proven ability to successfully interact with regulatory authorities.

On offer is a very competitive package including a high-end basic salary, bonus of 20-30% and a generous LTi package worth potentially an additional 30-40% of your yearly basic salary. Healthcare and insurances are all fully comprehensive.  My client offers a flexible hybrid system of home and office working, to help build and develop innovation working solutions and strategies, and to also enable and encourage information sharing within the teams and project groups.

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact me, Theo Moore, for this role by email to theo@advtalent.com or if you would like more information on the role, on US 908-348-6714. I will support you throughout the interview and on-boarding experience.

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