Insmed
Executive Director, Regulatory Affairs CMC
Insmed, Bound Brook, New Jersey, United States, 08805
Regulatory Cmc Leadership And Strategy
This position is a key role that will provide regulatory CMC (RA CMC) leadership and strategy to achieve regulatory approvals in various countries. As a strategic function, RA CMC is required to collaborate closely with multiple functions within Insmed and with external CROs/CMOs. A successful candidate will provide knowledge, understanding, interpretation, and utilization of regulatory guidance and regulations from various health authorities, as well as industry and government agency best practices and trends. Responsibilities: Plan, implement, and manage regulatory submissions for compounds in various phases of clinical development, marketing applications, and post-approval lifecycle activities by working with various teams. Provide regulatory strategies and identify the gaps and challenges of CMC development to ensure the approvability of the drug products worldwide with the flexibility for post-approval maintenance and lifecycle management of the marketed products. Develop plans for the preparation of CMC meetings with the regulatory agencies, and draft and review regulatory documents for agency meetings. Provide interpretation of applicable FDA/EMA/ICH/WHO global regulations to ensure CMC compliance within regulatory filings. Keep abreast of all pertinent regulations and guidance documents for pre- and post-approval submissions. As needed, communicate regulatory CMC requirements to team members and advise of implications of the regulatory CMC strategies to CMC development plan and activities. Contribute to scientific discussions and collaborations with scientists to resolve technical and regulatory issues in drug substance synthesis, management of impurities and degradation products, formulation, manufacturing process, and device combination product development at various development stages and product lifecycle management. Stay current with regulatory guidelines and industry standard methodologies to ensure the company's RA CMC activities are aligned with regulatory expectations. Lead and mentor a team of CMC professionals, encouraging a collaborative and high-performance culture. Requirements: Advanced degree (Ph.D. preferred) in a relevant scientific field (e.g., Chemistry, Chemical Engineering etc.). 12+ years of experience in pharmaceutical development and regulatory CMC within multinational pharmaceutical and biopharmaceutical companies, and 8+ years in a leadership position. Deep understanding of US, EU, and Japan regulations for drugs/biologics with the ability to identify the differences in regulations across the regions. Proven track record of close collaboration with Regulatory Agencies as the lead in agency interactions and product development meetings. Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market lifecycle support. Extensive understanding of relevant FDA, EU, ICH, PMDA guidelines, initiatives and regulations governing CMC drug product development. Ability to deal with issues of critical importance, provide regulatory strategy/advice, and make reasoned decisions on CMC regulatory issues for which there may not be clear or specific regulatory guidance. Past experience conducting end-to-end project management tasks within CMC RA. Active participation in Agency/Industry groups/forums expected. Ability to read and collate scientific and medical literature. Experience in drug substance and drug product development. Strong communication skills with demonstrated ability to optimally present ideas and influence others to achieve desired results. Ability to lead others without authority to move internal and external teams towards achieving goals that support Insmed's key strategic objectives. Flexible, diplomatic and able to nimbly deal with ambiguity. Must have a high degree of problem-solving proficiency and be adept at working across functions as a collaborative partner. Highly organized with strong attention to detail, clarity, accuracy, and conciseness. Salary Range: 247000-345467 Compensation & Benefits: Flexible approach to how we work Health benefits and time-off plans Competitive compensation package, including bonus Equity Awards (Long-Term Incentives) Employee Stock Purchase Plan (ESPP) Additional Information: Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Applications are accepted for 5 calendar days from the date posted or until the position is filled.
This position is a key role that will provide regulatory CMC (RA CMC) leadership and strategy to achieve regulatory approvals in various countries. As a strategic function, RA CMC is required to collaborate closely with multiple functions within Insmed and with external CROs/CMOs. A successful candidate will provide knowledge, understanding, interpretation, and utilization of regulatory guidance and regulations from various health authorities, as well as industry and government agency best practices and trends. Responsibilities: Plan, implement, and manage regulatory submissions for compounds in various phases of clinical development, marketing applications, and post-approval lifecycle activities by working with various teams. Provide regulatory strategies and identify the gaps and challenges of CMC development to ensure the approvability of the drug products worldwide with the flexibility for post-approval maintenance and lifecycle management of the marketed products. Develop plans for the preparation of CMC meetings with the regulatory agencies, and draft and review regulatory documents for agency meetings. Provide interpretation of applicable FDA/EMA/ICH/WHO global regulations to ensure CMC compliance within regulatory filings. Keep abreast of all pertinent regulations and guidance documents for pre- and post-approval submissions. As needed, communicate regulatory CMC requirements to team members and advise of implications of the regulatory CMC strategies to CMC development plan and activities. Contribute to scientific discussions and collaborations with scientists to resolve technical and regulatory issues in drug substance synthesis, management of impurities and degradation products, formulation, manufacturing process, and device combination product development at various development stages and product lifecycle management. Stay current with regulatory guidelines and industry standard methodologies to ensure the company's RA CMC activities are aligned with regulatory expectations. Lead and mentor a team of CMC professionals, encouraging a collaborative and high-performance culture. Requirements: Advanced degree (Ph.D. preferred) in a relevant scientific field (e.g., Chemistry, Chemical Engineering etc.). 12+ years of experience in pharmaceutical development and regulatory CMC within multinational pharmaceutical and biopharmaceutical companies, and 8+ years in a leadership position. Deep understanding of US, EU, and Japan regulations for drugs/biologics with the ability to identify the differences in regulations across the regions. Proven track record of close collaboration with Regulatory Agencies as the lead in agency interactions and product development meetings. Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market lifecycle support. Extensive understanding of relevant FDA, EU, ICH, PMDA guidelines, initiatives and regulations governing CMC drug product development. Ability to deal with issues of critical importance, provide regulatory strategy/advice, and make reasoned decisions on CMC regulatory issues for which there may not be clear or specific regulatory guidance. Past experience conducting end-to-end project management tasks within CMC RA. Active participation in Agency/Industry groups/forums expected. Ability to read and collate scientific and medical literature. Experience in drug substance and drug product development. Strong communication skills with demonstrated ability to optimally present ideas and influence others to achieve desired results. Ability to lead others without authority to move internal and external teams towards achieving goals that support Insmed's key strategic objectives. Flexible, diplomatic and able to nimbly deal with ambiguity. Must have a high degree of problem-solving proficiency and be adept at working across functions as a collaborative partner. Highly organized with strong attention to detail, clarity, accuracy, and conciseness. Salary Range: 247000-345467 Compensation & Benefits: Flexible approach to how we work Health benefits and time-off plans Competitive compensation package, including bonus Equity Awards (Long-Term Incentives) Employee Stock Purchase Plan (ESPP) Additional Information: Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Applications are accepted for 5 calendar days from the date posted or until the position is filled.