Associate Director, Global Regulatory Affairs

Title:

Associate Director, Global Regulatory Affairs

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.

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. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. 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:

WHAT - Summary & Purpose of the Position

The Associate Director, Global Regulatory Affairs is accountable for the development, continuous adaptation, and execution of regulatory strategies for assigned programs within the portfolio, either directly or through supervision of Regulatory Asset Team members. This role ensures the effective implementation of regulatory strategies across development and marketed products for assigned regions or worldwide.

The position provides regulatory expertise to R&D, Franchise, and Commercial Operations and serves as the primary interface between these functions and Global Regulatory Affairs on all regulatory matters related to development and product maintenance. The role is responsible for ensuring flawless execution of regulatory activities and for applying innovative and compliant approaches in collaboration with cross-functional teams and the regulatory science community.

The Associate Director is also responsible for regulatory intelligence within relevant disease areas, identifying and communicating emerging trends that may impact the business. The role requires maintaining a broad external perspective and may involve participating in external influencing activities with health authorities or trade associations, particularly where Ipsen’s regulatory policy may benefit from such engagement. In addition, the role leads or contributes to operational excellence initiatives within Global Regulatory Affairs.

WHAT - Main Responsibilities & Technical Competencies

Product/Project Leadership:

• 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; proposes remediation where possible.
• With Asset Team/Sub-teams, define appropriate strategy in terms of sequencing of 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.
• 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).
• Advocates to and seeks buy-in from senior leaders in Ipsen and Health Authorities to proposed strategies
• Responsible for ensuring potential risks have been identified and mitigation options proactively proposed for project team and senior management decision making.
• 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.
• Responsible for ensuring outsourced activities are delivered on time and on budget. Responsible for identifying and alerting management regarding any service issues.
• Review and input to all key documentation relevant to Franchise plans as required.
• Responsible for conducting regulatory due diligence assessment on external opportunities.
• Lead operational excellence initiatives within GRA.

Regulatory Intelligence:

• Accountable for continuously monitoring the scientific evolution of the assigned diseases within the therapeutic area for its regulatory impact; incorporates external environment into plans.
• Accountable for collecting, recording and sharing of competitive regulatory information for Ipsen competitor products for the assigned disease areas within the therapeutic area.
• Responsible for monitoring the external environment to identify trends and assess potential impact on business and communicates this information to stakeholders in a timely and compelling way
• Responsible for promoting activities and processes to reinforce "good external influencing behaviours" in the GRA organization

Building Relationships with Regulators:

• Build effective relationships with global regulators for professional communications on Ipsen strategy in relation to assigned products/disease areas.

Communication:

• Ensures timely and accurate information of regulatory developments to all stakeholders (Management, governance committees, development and commercialization teams, Public Affairs, Legal, Investor Relations, etc.).

Budget:

• Contribute towards effective planning of the GRA budget.

Ethics and Compliance:

• Accountable for ensuring all activities are conducted in line with Ipsen’s ethics and compliance policies

HOW - Knowledge & Experience

Knowledge & Experience (essential):

• Significant experience in the pharmaceutical industry, including 7+ in Regulatory Affairs.
• Proven experience of drug development and managing complex worldwide products/projects within a relevant therapeutic area, in key geographies.
• Excellent written and oral communication skills and delivers all communication with clarity and impact. Commands attention through a range of communication styles.
• Ability to distil key information from complex and extensive sources and present the information in a constructive way.
• Demonstrated project management capability in developing and implementing long-term plans and delivering large-scale projects.
• Consistent ability to foster strong matrix working and strong 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.
• Demonstrated capability to influence decision makers both internally and externally
• Strategic thinking with demonstrated success in deriving creative solutions to regulatory challenges, while balancing Agency expectations and ensuring compliance across all regions.
• Continuous focus on performance improvement and excellence in execution, with the ability to challenge ways of working and improve processes to reduce barriers for others.
• Demonstrated ability to lead change and communicate difficult messages effectively.

Knowledge & Experience (preferred):

• Track record of building excellent relationships with FDA. Knowledge of EU and Asia Pacific (mainly China and Japan) regulatory environment would be a plus.
• Knowledge of medical device / drug device combination regulations is strongly preferred.

Education / Certifications (essential):

• Advanced degree (or equivalent) in scientific discipline (not limited to Pharmacy, Medicine, Chemistry, Biological Sciences) is required.

Language(s) (essential):

• Fluent in English.

We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application. Ipsen is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.