Ipsen
Senior Director, Global Regulatory Affairs, Oncology
Cambridge (US) · Director
Sponsorship not specified$270k-$330kDetected 32 days ago
Project ManagementNegotiationIntellectual PropertyFDA RegulatoryMedical DevicesResearchLeadershipCommunicationCollaborationRegulatory Affairs
About the role
- Title: Senior Director, Global Regulatory Affairs, Oncology Company: Ipsen Biopharmaceuticals Inc.
- About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience.
- Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.
Responsibilities
- We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact.
- Support recruitment, train, develop and retain regulatory professionals within GRA;
- Oversee regulatory activities assigned to his/her direct reports where applicable and manage performance and all applicable processes
- Lead the preparation of submissions incl PIP, scientific advice, orphan drug designation submissions.
Requirements
- Significant experience in the pharmaceutical industry, including minimum 15 years in Regulatory Affairs.
- Proven experience of drug development/registration and managing complex worldwide products/projects within a relevant therapeutic area, in key geographies.
- Ability to distill key information from complex and extensive sources and to present the information in a constructive way.
- Consistent ability to foster strong matrix working.
- Proven track record of facilitating groups of individuals to work together on innovative regulatory solutions.
- Proven capability to influence decision makers both internally and externally.
- Strategic thinking with a proven ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions.
- Advanced degree (or equivalent) in scientific discipline (not limited to Pharmacy, Medicine, Chemistry, Biological Sciences).
- In collaboration with other functions, ensure the establishment of CCDS and required safety plans for the assigned product.
Compensation
- The annual base salary range for this position is $270,000 to $330,000
Benefits
- Carry strategy beyond Marketing Authorization, to incorporate Pricing & Reimbursement considerations, in collaboration with Health Outcomes and Pharmacoeconomics.
- Advocate to and seek buy-in from senior leaders in Ipsen and Health Authorities to proposed strategies
Company info
- Ipsen Biopharmaceuticals Inc.
- About Ipsen:
- Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience.
- Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries.
- At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company's success.
- Join us on our journey towards sustainable growth, creating real impact on patients and society!
- For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.
- Job Description:
- The Senior Director, Global Regulatory Affairs, Oncology is accountable for providing regulatory strategic leadership to assigned program(s) and implementing regulatory tactics to support the execution of regulatory activities across assigned region(s) or globally, while providing regulatory expertise to R&D, Franchise, and Commercial Operations for assigned products and projects and serving as the primary interface between these functions and Global Regulatory Affairs on all regulatory matters related to Development and Product Maintenance activities.
- The role ensures the development and flawless execution of regulatory strategies for assigned products and projects, including all components across both development and marketed products within assigned region(s) or globally, and performs Regulatory Intelligence for relevant disease areas, identifying and communicating implications of emerging trends that may impact the business.
- Additionally, the Senior Director maintains a broad perspective on external influencing issues, participates in external engagement activities with health authorities or trade associations where appropriate, and leads operational excellence initiatives within Global Regulatory Affairs.
- WHAT - Summary & Purpose of the Position
This listing is sourced directly from Ipsen's careers page and normalized into a canonical job model.