Vice President/Senior Vice President Regulatory Affairs

Global Life Science Hub is partnered with an innovative biopharmaceutical company specializing in difficult-to-formulate biologics in the Oncology and Infectious Disease fields. Recently, the company has achieved 2 FDA approvals and is now transitioning from R&D to a full-scale commercial organization. With a highly robust pipeline of advanced assets and expected approvals lined up until 2030, the company is positioned for significant growth.

As the new SVP of Regulatory Affairs, the successful candidate will lead the regulatory team in developing and implementing global regulatory strategies for the company's pipeline products as they expand beyond the USA. The ideal applicant should have a successful record in registering biologics and biosimilars and be able to commute to New Jersey on a 25% basis.

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; and
• 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:

• A degree within a life science field is mandatory. Advanced degree preferred (PhD/PharmD) is desirable
• 15+ years of industry experience, with at least 10 years working in regulatory affairs
• Regulatory experience with Biologics and Biosimilars 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 (e.g. FDA, EMA)
• 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