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: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.
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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: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.
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