About the Role:
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 authority, as well as industry and government agency best practices and trends.
Responsibilities will include, but are not limited to, the following:
- Plan, execute and manage regulatory submissions for compounds in various phases of clinical development, marketing applications, and post-approval lifecycle activities by working with various team.
- 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 CMC meetings with the agencies.
- 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 actvities.
- 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.
- Bachelor's, Master’s or Doctorate level degree in chemistry, enginerring, pharmacy, or other healthcare-related professions or life sciences required.
- Minimum ten (10) years pharmaceutical Regulatory CMC experience in multinational companies, including experience as a RA CMC product lead, or equivalent industry experience.
- A solid understanding of US, EU, and Japan regulations for drugs/biologics 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 FDA, EU, ICH, PMDA 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.
- Practical examples of end-to-end project management within CMC RA or relevant experience.
- Active participation in Agency/Industry groups/forums expected.
- Ability to read and collate scientific and medical literature is also required.
- Experienced in the drug substance 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.