Company Description:
Consistently Ranked Science’s Top Employer
A Certified Great Place to Work®
Summary: EMEA Regulatory Lead for Selected Projects • EMEA Regulatory strategy, tactical regulatory implementation and regulatory activities for selected projects, in alignment with the Head of EMEA Regulatory Affairs, GRLs, Global stakeholders and the EMEA business • Regulatory Lead for selected projects for clinical trials outside of North America and Japan, including but not limited to the EU CTR • Representation of EMEA RA for selected projects at GCTs, GRTs and assigned multifunctional teams Responsibilities:
For more information on U.S. benefits click here.
Additional Information:
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.
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.
Summary: EMEA Regulatory Lead for Selected Projects • EMEA Regulatory strategy, tactical regulatory implementation and regulatory activities for selected projects, in alignment with the Head of EMEA Regulatory Affairs, GRLs, Global stakeholders and the EMEA business • Regulatory Lead for selected projects for clinical trials outside of North America and Japan, including but not limited to the EU CTR • Representation of EMEA RA for selected projects at GCTs, GRTs and assigned multifunctional teams Responsibilities:
- Develop Regulatory Strategy for selected projects for EMEA Region, closely integrated with the Global Regulatory Strategy, Global Projects and the EMEA Business
- Representation EMEA Regulatory Affairs in Regional and Global Fora, interfacing with regulatory and multifunctional stakeholders, as to ensure overall product/project alignment for designated areas
- Development, management and implementation of Regulatory plans for selected projects for EMEA Region
- Communicate regulatory requirements to ensure optimal execution of the regulatory activities for selected projects in EMEA Region
- Lead development and submission of briefing packages to Regulatory Agencies in the EMEA Region for selected projects, e.g. but not limited to Requests for Scientific Advice, PIP Submissions, Meetings with the Agencies.
- Lead eventual development of MAAs and post approval Variations in EMEA region for selected projects
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EMEA Regulatory Lead for clinical trials on selected project outside of North America and Japan, including but not limited to the EU CTR
- 5+ years of experience and broad knowledge in the field of pharmaceutical Regulatory Affairs
- Track record of contributing to and implementation of Regulatory Strategy
- Experience with planning, preparing, and filing original applications, Variation submissions
- Good understanding of the EMEA and MHRA regulatory landscape, especially Health Authority regulations, guidance documents, processes, and timelines
- Bachelor’s degree in Life Sciences
- Team player with the ability to successfully collaborate and partner in a dynamic and culturally diverse workplace.
- Strategic mindset
- Excellent communication skills (verbal and written) .
- Proficient in English
- Highly organized with a strong attention to detail, clarity, accuracy and conciseness
- Critical Thinking
- Understand, identify, and act by the Insmed 5 values: Collaboration, Accountability, Passion, Respect, and Integrity
- Listen to and value others’ thoughts and ideas.
- Demonstrate self-awareness, humility, and curiosity in service of self-development.
- Embrace diversity and strive for inclusion and belonging
- Ability to work in a growing, fast-changing environment·
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.
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