Job Description

Our Client

Our client is a Global Biotechnology company, with a strong reputation for developing new products and treatments that improve people's lives. They have a strong and varied pipeline across several modalities (small molecule, biologicals, vaccines, C&G Therapy) and a rich and diverse group of commercialized products, sold and distributed globally. The Therapy areas include Oncology and Neurology, and the Regulatory function is led by the Global HQ in New Jersey.

The Role

We are recruiting for a senior Regulatory Affairs professional with strong Regulatory Affairs CMC experience in the pharmaceutical industry across a broad range of therapeutic areas and formulations to take the lead as a Regulatory Affairs CMC Director for a variety of Combination Products in a Global strategic role.

You will be someone who enjoys being in a leadership position, who has been responsible for developing and implementing the CMC & Device regulatory strategy and submission plans for assigned projects/products to deliver timely approvals to meet business needs in regions assigned. You will have led IND/IMPD submissions for phase 3 clinical trials and led/supported NDA/MAA submissions and global registrations.

The Culture

The culture here is focused on collaborative innovation and positive engagement, in a role that is pivotal to the growth of the combination products portfolio. You will have support from an engaged VP of Regulatory Affairs who will offer advice, guidance, and mentoring when needed or requested, in a role that is well-resourced where you will be expected to push the boundaries of innovation and involvement of autoinjector and other combination products. Promotions and career advancement are the norm here, as is the expectation that you continue to grow and develop your knowledge, expertise, and leadership abilities.

Responsibilities

• Serve as regulatory affairs CMC Director, Combination Products supporting cross-functional teams for assigned device and combination products in development (US and EU) and/or commercialized globally
• Offer and show leadership around the review of Regulatory Strategies and the delivery of complex IND/CTA/BLA/NDA/MAAs, while also providing responses to health authority questions and requests for information
• Collaborate with the team and cross-functional partners to tackle complex project issues, and offer recommendations to the Regulatory leadership team when necessary.

Experience needed:

• Regulatory CMC experience in medical device and combination product research, development and/or manufacturing
• Regulatory CMC experience in (IND, CTA, BLA, MAA) with a drug-device product
• Demonstrated sound understanding of related fields (e.g., manufacturing, process development, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem-solving
• Adapt to shifting priorities and handling unforeseen circumstances
• Strong abilities in leadership, project management, communication, interpersonal relations, and negotiation
• Capability to come up with creative resolutions for intricate regulatory issues and adeptly collaborate and convey information to significant stakeholders
• You will be a motivated Pharmaceutical Regulatory Affairs professional with a proven track record of defining robust strategies and delivering dossiers of the highest standards with extensive knowledge of regulatory procedures ensuring successful registration and maintenance within the US, EU, and RoW.

The Package

On offer is a very competitive package that includes a high basic salary, insurance benefits, extensive healthcare, a lucrative bonus based on company and personal performance, retirement benefits, paid holiday, and a comprehensive LTi plan.

If you are interested in applying for this position or hearing/receiving more information, in the first instance please contact me, Theo Moore, via Theo@Advtalent.com or call me directly at +1  587.216 9302 – You can also email my colleague, Ivan Nash, at Ivan.Nash@advtalent.com and we will support you with your application or request for more information.