Associate Director, Global Regulatory Affairs

Ipsen•Cambridge, MA

About The Position

The Associate Director, Global Regulatory Affairs develops, continuously adapts, and executes regulatory strategies for assigned portfolio programs, either directly or by supervising Regulatory Asset Team members. The role ensures effective implementation of strategies across development and marketed products in assigned regions or worldwide. It provides regulatory expertise to R&D, Franchise, and Commercial Operations and serves as the primary Global Regulatory Affairs interface for regulatory matters related to development and product maintenance. The position ensures compliant, high-quality execution of regulatory activities in collaboration with cross-functional teams and the regulatory science community. It monitors regulatory intelligence and disease-area trends, communicates potential business impacts, and may participate in external influencing activities with health authorities or trade associations. The role also leads or contributes to Global Regulatory Affairs operational excellence initiatives. The Associate Director shapes product and project strategy, including target product profiles, development plans, indication and geographic sequencing, labeling, regulatory consultations, risk mitigation, and post-authorization considerations such as pricing and reimbursement. The role builds relationships with regulators, communicates developments to stakeholders, contributes to budget planning, and ensures activities comply with Ipsen policies.

Requirements

Significant pharmaceutical industry experience, including at least 7 years in Regulatory Affairs.
Proven experience in drug development and management of complex worldwide products or projects within a relevant therapeutic area and key geographies.
Excellent written and oral communication skills, with the ability to communicate clearly and impactfully in a range of styles.
Ability to distill key information from complex and extensive sources and present it constructively.
Demonstrated project management capability in developing and implementing long-term plans and delivering large-scale projects.
Ability to foster effective matrix working and facilitate groups in developing innovative regulatory solutions.
Strong interpersonal and negotiation skills, with the ability to build and leverage networks inside and outside Ipsen.
Demonstrated ability to influence decision-makers internally and externally.
Strategic thinking and a record of developing creative regulatory solutions while balancing agency expectations and compliance across regions.
Focus on performance improvement and execution excellence, including the ability to challenge existing practices and improve processes.
Demonstrated ability to lead change and communicate difficult messages effectively.
Advanced degree or equivalent in a scientific discipline, such as Pharmacy, Medicine, Chemistry, or Biological Sciences.
Fluent in English.

Nice To Haves

Track record of building excellent relationships with the FDA.
Knowledge of the EU and Asia-Pacific regulatory environments, particularly China and Japan.
Knowledge of medical device and drug-device combination regulations.

Responsibilities

Provide regulatory input into target product profiles and Integrated Asset Strategic Plans.
Define, adapt, and execute regulatory strategies and plans for assigned products and programs across development and marketed products.
Work with cross-functional teams to establish plans that support target product profiles and account for the timing and requirements of key markets.
Continuously assess development objectives, new findings, regulatory requirements, timelines, and potential label impacts; propose adaptations and remediation where possible.
Define strategies for sequencing indications, dosage forms, and geographies, and establish an optimal product label balancing commercial expectations, regulatory requirements, and development outcomes.
Identify opportunities and constraints for achieving the optimal label and propose alternative solutions.
Incorporate commercialization challenges, including trademarks, licensing, product sourcing, legal status, and distribution channels, into regulatory strategy.
Extend regulatory strategy beyond marketing authorization to address pricing and reimbursement in collaboration with Health Outcomes and Pharmacoeconomics.
Work with relevant functions to establish the CCDS and required safety plans for assigned products.
Incorporate regional regulatory requirements into global plans in collaboration with local and intercontinental Regulatory Affairs teams.
Define and execute strategies for regulatory consultations, such as Scientific Advice, planned FDA meetings, and regulatory boards.
Advocate proposed strategies to, and seek support from, Ipsen senior leaders and health authorities.
Identify project risks proactively and propose mitigation options for project teams and senior management.
Ensure effective execution and implementation of Global Regulatory plans and activities using internal or external resources and Ipsen tools and processes.
Ensure outsourced activities are delivered on time and within budget, and alert management to service issues.
Review and provide input to key documentation related to Franchise plans.
Conduct regulatory due diligence assessments for external opportunities.
Lead or contribute to operational excellence initiatives within Global Regulatory Affairs.
Monitor scientific developments in assigned diseases for regulatory impact and incorporate external developments into plans.
Collect, record, and share competitive regulatory information for relevant competitor products and disease areas.
Monitor external trends, assess potential business impacts, and communicate findings to stakeholders in a timely and compelling way.
Promote activities and processes that reinforce good external influencing behaviors within Global Regulatory Affairs.
Build effective relationships with global regulators and communicate professionally about Ipsen strategy for assigned products and disease areas.
Ensure timely, accurate communication of regulatory developments to management, governance committees, development and commercialization teams, and other stakeholders.
Contribute to effective Global Regulatory Affairs budget planning.
Ensure activities are conducted in accordance with Ipsen ethics and compliance policies.