Vice President of Regulatory Affairs - Jacobs Management Group

Are you ready to make a meaningful impact in the world of biotech? My client is a pioneering company at the forefront of developing autologous stem cell therapies for neurodegenerative disorders such as ALS, MS, and Parkinson’s disease. These life-altering diseases represent unmet medical needs, and they are committed to advancing innovative therapies to address these challenges. Make a tangible impact on the lives of patients by leading the regulatory efforts for cutting-edge therapies.

Why You Should Apply:

• Lead regulatory affairs for groundbreaking stem cell therapies in neurodegenerative diseases.
• Shape the regulatory strategy for a pioneering biotech company.
• Collaborate with cross-functional teams on global regulatory submissions.

What You’ll Be Doing:

• Regulatory Strategy Development: Develop and implement regulatory strategies that support the company's clinical development programs, with a focus on ALS, MS, and Parkinson's therapies.
• Regulatory Submissions: Oversee and manage the preparation, submission, and approval process of regulatory filings, including BLAs, INDs, and other necessary submissions.
• Compliance Management: Ensure that all company activities comply with relevant regulatory requirements and guidelines, including FDA, EMA, and other global regulatory bodies.
• Cross-functional Collaboration: Work closely with clinical, quality, and manufacturing teams to ensure alignment on regulatory strategies and compliance requirements.
• Regulatory Intelligence: Stay abreast of the evolving regulatory landscape, particularly related to neurodegenerative diseases, and provide insights to the executive team.
• Leadership and Mentorship: Build and lead a high-performing regulatory affairs team, providing mentorship and fostering a culture of compliance and continuous improvement.
• Stakeholder Communication: Serve as the primary liaison with regulatory authorities and represent the company in meetings with agencies and external partners.

About You:

• Be able to do the job as described.
• Expert in global regulatory requirements for neurodegenerative therapies.
• Proven leader with strong project management and collaboration skills.
• Excellent communicator, capable of effective interaction with regulatory bodies.
• Thrive in a fast-paced, dynamic environment with multiple priorities.

How To Apply:

We’d love to see your resume, but we don’t need it to have a conversation. Send an email to ccupo@jacobsmgt.com and tell me why you’re interested. Or, if you do have a resume ready, apply here.