Senior Manager Regulatory

Title:

Senior Manager Regulatory

Company:

Ipsen Innovation (SAS)

 

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:

As a Senior Manager in Global Regulatory Affairs, you will develop and be responsible for the flawless execution of regulatory strategies for all assigned projects, including products in early development and/or the life cycle management of mature products and all of its components, across major global regions.  You will be responsible for the strategy, tactics, and implementation of all regulatory aspects of the assigned projects and its major components.

Additionally, you will provide regulatory expertise to R&D, Franchise, and Commercial Operations for your assigned projects. Acting as the interface between R&D, Franchise, Operations, and GRA, you will address all regulatory issues relevant to development and product maintenance activities within your assigned projects. Furthermore, you will be responsible for Regulatory Intelligence in relevant disease areas, identifying and communicating the implications of upcoming trends that may impact the business.

Main responsibilities / job expectations

Responsibilities

• 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.
• Contributes to process improvement initiatives on behalf of GRA as required.

Product/Project Leadership

• Provide regulatory input into target product profile (target indications, therapeutic positioning, and key differentiating characteristics).
• Provide regulatory input into the Integrated Development Plan. In collaboration with other Research & Development 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 match between development objectives and current plan versus new key findings and regulatory requirements. In collaboration with R&D, Franchise, Operations and Project Teams, ensure plan adaptation when needed. Assess impact on timelines and/or label; proposes remediation where possible.
• Lead the preparation of PIPs, scientific advice/FDA meetings, orphan drug designation submissions.
• With R&D, Franchise, Operations and Asset 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.
• With Franchise, contribute to the definition of the appropriate strategy for the assigned product/project.
• 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.
• In collaboration with local Regulatory Affairs, define and execute strategy for regulatory consultation and means (e.g., Scientific Advice, FDA planned meetings, regulatory boards).
• Responsible for ensuring potential risks have been identified and mitigation options proactively proposed for project team and senior management decision making.

Regulatory Intelligence

• Responsible for continuously monitoring the scientific evolution in the assigned disease areas for its regulatory impact; incorporates external environment into plans.
• Contributes to collecting, recording, and sharing of competitive regulatory information for Ipsen competitor products.
• Contributes to monitoring the external environment to identify trends, assess potential impact on the business, and communicates this information to stakeholders in a timely and compelling way.

Building Relationships with Regulators

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

Communication

• Responsible for ensuring 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.

Knowledge, abilities & experience

Education / Certifications:

• Master's degree (or equivalent) in a scientific discipline, such as Pharmacy, Medicine, Chemistry, or Biological Sciences is preferred.

Experience:

• Minimum of 8 years of related experience with a bachelor’s degree; or 6 years and a master’s degree; or a PhD with 3 years’ experience; or equivalent experience.
• Experience of drug development and managing complex products/projects within a relevant therapeutic area, in key geographies.

Languages:

•  Fluent in English

#LIHybrid

Dans le cadre de ses recrutements IPSEN s’engage au respect de l’égalité de traitement des candidats, indépendamment du sexe, de l’âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat.