Director, Regulatory Affairs CMC - EMEA

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

Named Science’s Top Employer in 2021, 2022, and 2023

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 were named the No. 1 company to work for in the biopharma industry in Science’s Top Employers Survey for two years in a row.

A Certified Great Place to Work

We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.

Summary

This position is a key role that will provide regulatory CMC (RA CMC) leadership and strategy to achieve regulatory approvals in EMEA region. As a strategic function, RA-CMC EMEA 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 authority, as well as industry and government agency best practices and trends.

Responsibilities

• Plan, execute and manage regulatory submissions 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 in Europe regions with the flexibility for post-approval maintenance and lifecycle management of the marketed products.
• Develop plans for the preparation of CMC meetings with the EMA and other regulatory agencies, and draft and review regulatory documents for CMC meetings.
• Provide interpretation of applicable EMA/ICH/WHO, and other country specific regulations to ensure the compliance of CMC content within regulatory filings. Keep abreast of all pertinent regulations and guidance documents for pre & post-approval submissions. As needed, communicate regulatory CMC requirements to CMC development 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.
  
  

Experience/Knowledge:

• Minimum ten (10) years pharmaceutical development and regulatory CMC experience in multinational companies, including experience as a RA CMC product lead, or equivalent industry experience.
• A solid understanding of EU, ICH, country specific regulations for drugs/biologics registration with the ability to identify the differences in regulations across the regions. Proven ability to liaise with regulatory agencies as 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.
• Working knowledge of relevant EU, ICH, WHO, other country specific guidelines, initiatives and regulations governing CMC drug product development.
• Able 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 with specific regulatory guidance.
• Active participation in Agency/Industry groups/forums expected.
• Ability to read and collate scientific and medical literature is also required.
  
  

Skills/Capabilities:

• Experienced in the drug substance and drug product development in terms of manufacturing process development and impurity controls, etc.
• Strong communication skills with the ability to effectively present ideas and influence others that 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 effectively deal with ambiguity, problem solving, and works effectively across functions as a team player.
• Highly organized with strong attention to detail, clarity, accuracy and conciseness
  
  

Travel Requirements

Domestic and/or International travel required (10%)

Compensation & Benefits

We’re committed to investing in every team member’s total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world.

Additional Information

Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. 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.

Applications are accepted until the position is filled.