Executive Director, Regulatory Affairs CMC

Company Description

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

Recognitions

 

Consistently Ranked Science’s Top Employer

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we’ve been named the No. 1 company to work for in the biopharma industry in Science’s Top Employers survey for four years in a row.

 

  

 

 

A Certified Great Place to Work®

We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.

  

 

Overview

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.

#LI-MM1#LI-Remote

Salary Range

247000-345467

Compensation & Benefits

At Insmed, we’re committed to investing in every team member’s total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:

• 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)

 

For more information on U.S. benefits click here.

 

 

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.

 

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

 

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 [email protected] 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. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

 

Applications are accepted for 5 calendar days from the date posted or until the position is filled.