Title:
Senior Manager, Global Regulatory Affairs
Company:
Ipsen Bioscience, Inc.
Job Description:
Summary / purpose of the position
As a Senior Manager in Global Regulatory Affairs, you will develop and supervise the implementation 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 regions such as Europe and the USA, or even worldwide. You will be responsible for the strategy, tactics, and implementation of all regulatory aspects of the assigned projects and its major components, including PIP, scientific advice, and orphan drug designation submissions for a major region or worldwide.
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.
You will also ensure the flawless execution and implementation of regulatory strategies activities for your assigned projects (products in early development and/or life cycle management of mature products), working closely with R&D, Franchise, Operations, and the regulatory science community to bring innovative and compliant approaches to the development and maintenance of these products.
Main responsibilities / job expectations
Responsibilities will include, but are not limited to the following:
- 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 regulatory due diligence assessment on external opportunities as required.
- Contributes to process improvement initiatives on behalf of GRA.
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:
Key Technical Competencies Required
- Good written and oral communication skills and capable to deliver key communication with clarity and impact.
- Solid project management skills. Able to develop and implement short to mid-term plans or delivery of small to medium scale projects.
- Solid experience in matrix working environments, with a proven ability to facilitate collaboration among diverse groups to develop innovative regulatory solutions.
- Good interpersonal and negotiation skills with an ability to build networks within Ipsen and use them to secure appropriate support and outcome for a project.
- Capable of identifying issues in advance and seeking necessary input and support to resolve then. Ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions. Recognizes and highlights potential long-term issues for projects.
- Shows a constant focus on improving performance and excellence in all tasks. Challenges and questions ways of working to seek improved process.
The annual base salary range for this position is $112,500-$165,000.
This job is eligible to participate in our short-term incentives program as well as our long-term incentives program.
At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.
The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills.
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.