Jacobs Management Group
Vice President of Regulatory Affairs
Jacobs Management Group, Boston, Massachusetts, us, 02298
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.
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.