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.

• Evaluates materials to ensure compliance with EU regulations, guidance, corporate policies and business objectives.
• Works with Commercial, Medical and Legal colleagues to review and evaluate of the level clinical evidence provided to support proposed claims that are consistent with product labeling and in line with local country regulations for promotion.
• Provides consistent, well-supported, and clear guidance to key stakeholders.
• Serves as the chair of EU review meetings and coordinates meetings.
• Works with Commercial with the planning and prioritization of proposed promotional and disease state materials.
• Provides expert guidance/training related to Regulatory strategy to commercial and key stakeholders during early development of projects.
• Will also serve as the EU reviewer for Medical materials including MSL materials, Disease state presentations and clinical trial materials.
• Participates in review meetings to resolve potential issues and participates in escalation meetings, as needed.
• Supports metrics to measure and track effectiveness and efficiency of the review process.
• Understands broad concepts within regulatory affairs and potential implications across organization.
• Proactively identifies regulatory issues and risk mitigation strategies.
• Will be the contact point and expert matter for the core promotional review process in the EU and will manage the coordination down to country level affiliates.
• Collaborates with the US review teams for materials that are intended for global audiences.
• Independently manages local country review vendors.
• Serves as EU chair of the CRC process.
• Provides strong regulatory commercialization strategy from a Commercial Regulatory Affairs perspective.
• May be required to act as a final signatory if applicable in local countries.

• Minimum of 7 years’ experience in international review and approval process of pharmaceutical/biologics promotion.
• Ability to understand the basics in pharmaceutical promotion development and review process.
• Strong knowledge in EU promotional regulations and standards.
• Need interpersonal skills with ability to clearly and concisely communicate.
• Effective written and verbal communication skills Proven skills in negotiation, influencing without authority and working through potential conflict.
• Ability to work independently, take initiative and complete tasks to deadlines.
• Ability to manage vendor relationships/processes.

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
• Competitive compensation package, including bonus 
• Equity Awards (Long-Term Incentives)
• Employee Stock Purchase Plan (ESPP)

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 TotalRewards@insmed.com 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.