Rocket Pharmaceuticals
Senior Director, Regulatory CMC (Chemistry, Manufacturing, and Controls)
Rocket Pharmaceuticals, Cranbury, New Jersey, United States,
Overview:
Work at ROCKET PHARMA and help cure rare diseases!
Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.
Position Summary:
Rocket Pharma is seeking an accomplished and strategic Senior Director of Regulatory CMC to lead our Chemistry, Manufacturing, and Controls (CMC) regulatory affairs. This role is vital for ensuring that our CMC submissions meet regulatory requirements and align with our overall business strategy. The ideal candidate will possess extensive experience in CMC regulatory affairs, particularly in writing CMC sections for INDs, NDAs, BLAs, and MAAs, as well as strong leadership skills.Responsibilities:
Regulatory Strategy and Leadership:
Develop and implement regulatory strategies for CMC submissions, ensuring alignment with FDA, EMA, and other global regulatory requirements.
Provide strategic guidance to cross-functional teams, including R&D, manufacturing, and quality, to ensure CMC compliance throughout the product lifecycle.
Lead, mentor, and develop a high-performing team of regulatory CMC professionals, fostering a culture of excellence and continuous improvement.
CMC Submissions and Compliance:
Oversee the preparation, review, and submission of CMC regulatory documentation, including detailed CMC sections for INDs (Investigational New Drug Applications), NDAs (New Drug Applications), BLAs (Biologics License Applications), and MAAs (Marketing Authorisation Applications).
Ensure that CMC submissions are complete, accurate, and meet all regulatory requirements, including data integrity, quality standards, and regulatory guidelines.
Manage interactions with regulatory agencies, addressing queries, providing responses, and ensuring timely resolution of any issues related to CMC.
Writing and Documentation:
Lead the development and writing of CMC sections for regulatory submissions, ensuring that all content is scientifically accurate, regulatory compliant, and clearly communicates product development, manufacturing processes, and quality control measures.
Ensure that CMC documentation supports the overall regulatory strategy and meets the expectations of regulatory authorities in major markets.
Review and edit CMC sections prepared by internal teams or external partners to ensure consistency, accuracy, and compliance.
Cross-Functional Collaboration:
Collaborate with internal teams, including R&D, manufacturing, quality assurance, and legal, to integrate regulatory requirements into product development and manufacturing processes.
Provide regulatory input on product development plans, manufacturing changes, and quality control processes to ensure compliance and mitigate regulatory risks.
Regulatory Strategy and Policy Development:
Monitor and interpret changes in global regulatory requirements related to CMC, and advise on their impact on ongoing and future projects.
Develop and implement internal policies and procedures to ensure compliance with regulatory requirements and industry best practices.
Risk Management and Problem Resolution:
Identify and assess potential regulatory risks related to CMC and develop strategies to mitigate these risks.
Lead investigations into regulatory compliance issues or deviations, providing actionable solutions and corrective actions as necessary.
External Engagement:
Represent the company in interactions with regulatory agencies, industry groups, and other external stakeholders on CMC-related matters.
Stay informed about industry trends and regulatory developments, applying this knowledge to enhance the company's regulatory strategies and practices
Qualifications:
B.S./B.A required; advanced degree preferred (M.S., Ph.D., PharmD or equivalent) in a relevant scientific discipline.
Minimum of 10 years of experience in regulatory affairs with a strong focus on Chemistry, Manufacturing, and Controls (CMC).
Proven track record of managing CMC regulatory submissions and interactions with regulatory agencies in a pharmaceutical, biotech, or medical device environment.
Extensive experience in writing and preparing CMC sections for INDs, NDAs, BLAs, and MAAs, demonstrating thorough understanding of regulatory expectations and requirements.
Demonstrated ability to manage complex regulatory projects and lead cross-functional teams.
Deep knowledge of FDA, EMA, and other international regulatory requirements and guidelines related to CMC.
Strong leadership and management skills, with a demonstrated ability to build and lead high-performing teams.
Excellent analytical and problem-solving abilities, with a strategic approach to addressing regulatory challenges.
Exceptional communication and interpersonal skills, with the capacity to influence and collaborate effectively with internal and external stakeholders.
Ability to manage multiple projects and priorities simultaneously in a fast-paced, dynamic environment.
EEO Statement:
A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.
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Work at ROCKET PHARMA and help cure rare diseases!
Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.
Position Summary:
Rocket Pharma is seeking an accomplished and strategic Senior Director of Regulatory CMC to lead our Chemistry, Manufacturing, and Controls (CMC) regulatory affairs. This role is vital for ensuring that our CMC submissions meet regulatory requirements and align with our overall business strategy. The ideal candidate will possess extensive experience in CMC regulatory affairs, particularly in writing CMC sections for INDs, NDAs, BLAs, and MAAs, as well as strong leadership skills.Responsibilities:
Regulatory Strategy and Leadership:
Develop and implement regulatory strategies for CMC submissions, ensuring alignment with FDA, EMA, and other global regulatory requirements.
Provide strategic guidance to cross-functional teams, including R&D, manufacturing, and quality, to ensure CMC compliance throughout the product lifecycle.
Lead, mentor, and develop a high-performing team of regulatory CMC professionals, fostering a culture of excellence and continuous improvement.
CMC Submissions and Compliance:
Oversee the preparation, review, and submission of CMC regulatory documentation, including detailed CMC sections for INDs (Investigational New Drug Applications), NDAs (New Drug Applications), BLAs (Biologics License Applications), and MAAs (Marketing Authorisation Applications).
Ensure that CMC submissions are complete, accurate, and meet all regulatory requirements, including data integrity, quality standards, and regulatory guidelines.
Manage interactions with regulatory agencies, addressing queries, providing responses, and ensuring timely resolution of any issues related to CMC.
Writing and Documentation:
Lead the development and writing of CMC sections for regulatory submissions, ensuring that all content is scientifically accurate, regulatory compliant, and clearly communicates product development, manufacturing processes, and quality control measures.
Ensure that CMC documentation supports the overall regulatory strategy and meets the expectations of regulatory authorities in major markets.
Review and edit CMC sections prepared by internal teams or external partners to ensure consistency, accuracy, and compliance.
Cross-Functional Collaboration:
Collaborate with internal teams, including R&D, manufacturing, quality assurance, and legal, to integrate regulatory requirements into product development and manufacturing processes.
Provide regulatory input on product development plans, manufacturing changes, and quality control processes to ensure compliance and mitigate regulatory risks.
Regulatory Strategy and Policy Development:
Monitor and interpret changes in global regulatory requirements related to CMC, and advise on their impact on ongoing and future projects.
Develop and implement internal policies and procedures to ensure compliance with regulatory requirements and industry best practices.
Risk Management and Problem Resolution:
Identify and assess potential regulatory risks related to CMC and develop strategies to mitigate these risks.
Lead investigations into regulatory compliance issues or deviations, providing actionable solutions and corrective actions as necessary.
External Engagement:
Represent the company in interactions with regulatory agencies, industry groups, and other external stakeholders on CMC-related matters.
Stay informed about industry trends and regulatory developments, applying this knowledge to enhance the company's regulatory strategies and practices
Qualifications:
B.S./B.A required; advanced degree preferred (M.S., Ph.D., PharmD or equivalent) in a relevant scientific discipline.
Minimum of 10 years of experience in regulatory affairs with a strong focus on Chemistry, Manufacturing, and Controls (CMC).
Proven track record of managing CMC regulatory submissions and interactions with regulatory agencies in a pharmaceutical, biotech, or medical device environment.
Extensive experience in writing and preparing CMC sections for INDs, NDAs, BLAs, and MAAs, demonstrating thorough understanding of regulatory expectations and requirements.
Demonstrated ability to manage complex regulatory projects and lead cross-functional teams.
Deep knowledge of FDA, EMA, and other international regulatory requirements and guidelines related to CMC.
Strong leadership and management skills, with a demonstrated ability to build and lead high-performing teams.
Excellent analytical and problem-solving abilities, with a strategic approach to addressing regulatory challenges.
Exceptional communication and interpersonal skills, with the capacity to influence and collaborate effectively with internal and external stakeholders.
Ability to manage multiple projects and priorities simultaneously in a fast-paced, dynamic environment.
EEO Statement:
A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.
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