Vice President, Regulatory Affairs

Global Life Science Hub is partnered with an innovative biopharmaceutical company dedicated to developing novel medicines to address unmet medical needs. With multiple FDA approvals and a focus on various therapeutic areas, including oncology, and infectious diseases, this company has made significant strides in developing both small molecule and biological drug candidates.

As the company transitions into a full commercial organization, they seek a Vice President of Regulatory Affairs to take the reins from its retiring predecessor. The ideal candidate for this critical leadership position will have a strong background in regulatory affairs and a proven track record of success in developing and registering biologics and biosimilars, with experience in both small and large molecules.

As the new SVP of Regulatory Affairs, the successful candidate will be able to lead the regulatory team in developing and implementing global regulatory strategies for the company's pipeline products as they gear up for multiple approvals in the coming years.

Responsibilities

• Develop global regulatory strategies to gain earliest possible regulatory approval in US and other international markets with product labelling that sets a high hurdle for any competitors in the field
• Develop effective working relationships with FDA, EMEA, and other regulatory authorities, such as coordinating activities for meetings and leading approval negotiations
• Manage the compilation, submission and maintenance of INDs, BLA's and amendments
• Build and effectively lead high-performing Regulatory team
• Identify gaps in product development plans that may pose regulatory issues and come up with novel endpoint development strategies
• Develop and plan innovative regulatory strategies for label enhancements and life cycle product management.
• Act as the independent subject matter expert in giving guidance to project teams, departments, and management, while considering companywide implications Provide regulatory input to the business development group in the assessment of new product acquisition and product out-licensing candidates
• Manage post-market surveillance requirements for commercial products by assessing regulatory categorization of adverse events reported during use in the population and prepare/file expedited safety and periodic safety reports to FDA.
• Performs other functions as required or assigned
• Complies with all company policies and standards

Experience/Qualifications:

• 15+ years of industry experience, with at least 10 years working in regulatory affairs (regionally and/or globally)
• Substantial experience in all aspects of regulatory affairs, including Commercial support, CMC and Clinical and a track record of successful submissions and license approvals
• Regulatory experience with biologics and a successful track record leading major applications (such as BLA/MAA) and securing approval
• Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions
• Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance pertaining to drug development and commercialization.
• Substantial experience in representing the sponsor and interfacing and negotiating with regulatory authorities
• Demonstrated leadership ability as well as ability to be a team player and work well within cross-functional teams
• Unquestionable ethics, professional integrity and the ability to motivate and lead others
• Excellent oral communication and writing skills,
• Generates innovative solutions in work situations, trying different and novel ways to address work challenges and opportunities
• Proven ability to work in a small company environment where there is a need to play a both strategic and very hands on role

Apply:

The Global Life Science Hub are a niche Life Science headhunting firm. We place professionals across Europe and the US for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.

If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.glshub.com