Senior Director, Global Regulatory Affairs, Oncology

Ipsen•Cambridge, MA

1d•$270,000 - $330,000•Onsite

About The Position

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.

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.
Track record of building excellent relationships with FDA and/or EU and Asia Pacific (mainly China and Japan) regulatory environment.
Excellent written and oral communication skills.
Ability to deliver all communication with clarity and impact.
Command attention through a range of communication styles.
Ability to distill key information from complex and extensive sources and to present the information in a constructive way.
Solid project management skills with proven ability to develop and implement longer term plans or delivery of large-scale projects.
Consistent ability to foster strong matrix working.
Proven track record of facilitating groups of individuals to work together on innovative regulatory solutions.
Strong interpersonal and negotiation skills with a proven ability to build strong personal networks, both within and outside Ipsen and use them to secure appropriate support and outcome for a project.
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.
Shows a constant focus on improving performance and excellence in all tasks.
Challenges and questions ways of working to seek improved process.
Capable of seeing opportunities and revising processes or approaches to reduce barriers for others to be able to deliver more.
Proven ability to lead change and communicate difficult messages effectively.
Advanced degree (or equivalent) in scientific discipline (not limited to Pharmacy, Medicine, Chemistry, Biological Sciences).
Fluent in English Required.

Nice To Haves

Knowledge of medical device / drug device combination regulations would be a plus.

Responsibilities

Provide regulatory strategic leadership for the assigned program(s).
Be accountable for the development, flawless execution and implementation of regulatory strategic activities for the assigned programs for assigned region(s) or worldwide, working with R&D, Franchise, Operations and within the regulatory science community to bring innovative and compliant approaches to the development and maintenance of those products.
Be accountable for the development and continuous adaptation of the regulatory strategies for all assigned programs, either directly or through the supervision of the Regulatory Asset Team Member.
Provide regulatory input into target product profile (target indications, therapeutic positioning, and key differentiating characteristics).
Provide regulatory input into the Integrated Asset Strategic Plan.
In collaboration with other departments, define the optimal plan to reach the target product profile, taking into consideration the most favorable timing for all key markets.
Continuously evaluate the global match between development objectives and current plan versus new key findings and regulatory requirements.
In collaboration with relevant functions and Asset Team/Sub-teams, ensure plan adaptation when needed.
Assess impact on timelines and/or label; propose remediation where possible.
With Asset Team/Sub-teams, define appropriate strategy in terms of sequencing indications, dosage forms and geographies.
Establish optimal label with appropriate balance between commercial expectations, regulatory requirements, and development outcomes.
Identify opportunities and limiting factors for optimal label and propose alternative solutions.
Incorporate commercialization challenges into regulatory strategy (not limited to trademarks, licensing agreements, product sourcing, legal status, distribution channels).
Carry strategy beyond Marketing Authorization, to incorporate Pricing & Reimbursement considerations, in collaboration with Health Outcomes and Pharmacoeconomics.
Be responsible for Regulatory Intelligence for relevant disease area(s), and identify and communicate the implications of upcoming trends that may impact the business.
Consider regulatory avenues to maximize intellectual property protection and data exclusivity.
In collaboration with other functions, ensure the establishment of CCDS and required safety plans for the assigned product.
Ensure regional regulatory specificities and needs are incorporated into the global plans though collaboration with local and intercontinental RA where available.
Define and execute strategy for regulatory consultation (e.g. Scientific Advice, FDA planned meetings, regulatory boards).
Lead the preparation of submissions incl PIP, scientific advice, orphan drug designation submissions.
Advocate to and seek buy-in from senior leaders in Ipsen and Health Authorities to proposed strategies.
Be responsible for ensuring potential risks have been identified and mitigation options are proactively proposed for project team and senior management decision making.
Be accountable for the flawless execution and implementation of the related Global Regulatory plans and activities with internal or external resources as appropriate and by using Ipsen tools and processes.
Build effective relationships with global regulators for professional communications on Ipsen strategy in relation to assigned products/disease areas.
Be responsible for ensuring outsourced activities are delivered on time and on budget.
Be responsible for identifying and alerting management regarding any service issues.
Review and provide input into all key documentation relevant to Franchise plans as required.
Be responsible for conducting regulatory due diligence assessment on external opportunities.
Lead operational excellence initiatives within GRA.
Contribute towards effective planning of the GRA budget.
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.
Be accountable for ensuring all activities are conducted in line with Ipsen’s ethics and compliance policies.