Vice President, US Regulatory Affairs – New Jersey ($350,000 – $400,000)
Global Life Science Hub is proud to partner with a forward-thinking biopharmaceutical powerhouse that is revolutionizing the life science industry by developing novel medicines that address the most challenging unmet medical needs. Their captivating breakthroughs in oncology open new doors of hope for patients fighting cancer, while their mesmerizing advancements in CNS disorders and infectious diseases bring relief to those facing challenging health conditions.
With an impressive track record, they have successfully discovered and commercialized over 15 drugs, firmly establishing themselves as a true industry leader. Each day, they take incredible strides in advancing both small molecule and biological drug candidates, pushing the boundaries of medical innovation.
The VP of Regulatory will be pivotal in leading, driving, and executing all regulatory activities in the United States. This encompasses developing, implementing, and managing US regulatory strategies, regulatory submissions, regulatory affairs support teams, interactions with regulatory agencies, and staying abreast of regulatory changes for their products.
- Collaborate with the senior leadership team to set and execute the company’s strategy, fostering collaboration, representing the company, and driving initiatives.
- Develop, drive, and execute US regulatory strategies aligned with business objectives. Create plans to meet regulatory requirements, anticipate regulatory changes, build relationships with regulatory agencies, manage regulatory submissions, and ensure compliance for all company products pre- and post-approval.
- Communicate regulatory strategy to stakeholders, including regulatory professionals, senior management, R&D, quality, commercial, and regulatory agencies, ensuring alignment across the organization.
- Monitor progress and adjust regulatory strategy based on business priorities.
- Prioritize regulatory activities based on company objectives, ensuring critical tasks receive primary focus.
- Stay updated on regulatory changes and developments that may impact the company’s products.
- Establish and maintain strong relationships with regulatory agencies, industry associations, and advocacy groups.
- Provide expert regulatory guidance and support to internal teams, including legal, quality, commercial, and R&D.
- Provide leadership and direction to the US Regulatory Affairs-Global Development Project (RA-GDP) function. Ensure adherence to regulatory standards and timely market introduction of products. Oversee the US RA-GDP team, ensuring proper resource allocation and role alignment.
- Perform other assigned duties as required.
- Lead and oversee the RA-GDP teams, holding decision-making authority for the US functions listed above.
- Master’s or Doctoral Degree in regulatory affairs, public health, or life sciences-related discipline. Regulatory affairs certification, such as RAPS, is desirable.
- Minimum of 12-15 years of experience in regulatory affairs in the pharmaceutical industry, with a proven track record of securing regulatory approval for pharmaceutical products.
- In-depth knowledge of regulatory requirements, including FDA regulations and guidelines, and experience managing complex regulatory projects.
- Commitment to staying current with regulatory changes and developments, ensuring compliance with all relevant regulations.
- Excellent communication, leadership, and interpersonal skills, enabling effective collaboration with cross-functional teams, regulatory agencies, stakeholders, and senior leaders.
- Strong analytical and problem-solving skills, with the ability to assess regulatory risks, make informed decisions, and develop effective strategies.
- Ability to lead and motivate a team of regulatory affairs professionals, fostering shared and individual goals.
- Excellent organizational and project management skills, capable of managing multiple projects and meeting deadlines.
- Ability to establish relationships with regulatory professionals, internal and external stakeholders, such as regulatory agencies, industry associations, and advocacy groups.
- Adaptability to changing circumstances and willingness to travel, as necessary, to engage with regulatory agencies and other stakeholders.
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