Manager, Regulatory Affairs

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.

Summary: Providing regulatory management and coordination support for EMEA regulatory operations, processes, filing, best practices across EMEA Regulatory projects and product portfolio Responsibilities: - Execution of regulatory tactical operational plans and activities
- Communicate regulatory requirements to ensure optimal execution of the regulatory activities.
- Ensure timely preparation, review, and submission of documents/information to regulatory authorities and ensure compliance with applicable regulatory requirements for EMEA
- Coordinate, implement and track EMEA regulatory activities and submissions associated with Insmed’s product development, and post-approval activities.
- Maintain knowledge of changing regulatory requirements and advise Quality as appropriate (Regulatory Intelligence)
- Interface with regulatory and multifunctional stakeholders, as to ensure overall product/project alignment for designated areas
- Operates in accordance with Insmed’ s SOPs and systems
- Support the EU regulatory function in connection with any mock/potential or actual product recalls for products across the region.
- EMEA Regulatory Quality contact for designated product Change Controls
- EMEA regulatory contact for designated products /projects in connection PV/Drug Safety for the EMEA region.
- Coordination of PSURs. EMEA regulatory contact for Insmed PV/Drug Safety doe marketed products.

Experience and Education:

- 3+ years of experience and broad knowledge in the field of pharmaceutical Regulatory Affairs
- Good understanding of the EMEA and MHRA regulatory landscape, especially Health Authority regulations, guidance documents, processes, and timelines
- Bachelor’s degree in Life Sciences

**Skills**:

- Team player with the ability to successfully collaborate and partner in a dynamic and culturally diverse workplace.
- Excellent communication skills (verbal and written).
- Proficient in English
- Highly organized with a strong attention to detail, clarity, accuracy and conciseness
- Critical Thinking

Ability to:

- 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
- 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 informaion on U.S. benefits click here.

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.

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