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Director, Regulatory Affairs Cmc
4 maanden geleden
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.- 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/Af
