Director, Global Regulatory Affairs - Neurology

Title:
Director, Global Regulatory Affairs - Neurology

Company:
Ipsen Bioscience, Inc.

Job Description:

Position Summary

The purpose of this position is to build a strong relationship with the FDA and act as the primary FDA regulatory liaison for the neurology franchise in development and registration matters. The Director of Global Regulatory Affairs will be accountable for the strategy, tactics and implementation of all regulatory aspects of the assigned programs and all of its components worldwide. He/She will provide regulatory expertise to R&D, Franchise and Commercial Operations for assigned products/projects and act as the interface between the R&D/Franchise/Operations and GRA on all regulatory issues relevant to Development and Product Maintenance activities within the assigned product/project. In this position, the Director will ensure the development and flawless execution of regulatory strategies for the assigned products/projects and all of its components (both development and marketed products) worldwide. They will be responsible for Regulatory Intelligence for relevant disease area and to identify and then communicate the implication of upcoming trends that may impact the business. He or She will be responsible for having a broad perspective on external influencing issues as he/she may participate in external influencing activities with health authorities or trade associations, particularly those that would benefit from a broad perspective on Ipsen regulatory policy. Lastly, they will lead operational excellence initiatives within GRA.

Essential Functions

Responsibilities

Responsibilities will include, but are not limited to, the following:

Overall Accountability:

• Accountable for the development, flawless execution and implementation of regulatory strategies activities for the assigned programs worldwide, working with R&D, Franchise, Operations and within the regulatory science community to bring innovative and compliant approaches to thedevelopment and maintenanceof those products.

Product/Project Leadership:

• Accountable for the development and continuous adaptation of the regulatory strategies for all assigned programs within the assigned portfolio, either directly or through the supervision of the Regulatory Team:

• 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 global 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.
• With R&D, Franchise, Operations and Project 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.
• Consider regulatory avenues to maximize intellectual property protection and data exclusivity.
• In collaboration with other GMRS 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.
• In collaboration with local Regulatory Affairs, define strategy around regulatory consultation and means (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 behaviors" 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

• Complies with all laws, regulations and policies that govern the conduct of Ipsen U.S. staff

Qualifications

Education

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

Experience

• Ideal: Proven experience in managing complex worldwide products/projects.
• At least 12 years professional experience in the pharmaceutical industry, including minimum 10 years in Regulatory Affairs.

Core Competencies (Specific knowledge, skills and abilities that enable an individual to effectively perform the job)

• 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.
• 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 improve process. Capable of seeing opportunities and revising process or approach to reduce barriers for others to be able to deliver more. Proven ability to lead change and communicante
• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
• Regularly required to operate standard office equipment (personal computer, photocopy machine, fax machine, etc.)
• Ability to work on a computer up to 7 hours a day. Close vision required for computer usage
• Regularly required to sit for long periods of time, and occasionally stand and walk.
• Regularly required to use hands to operate computer and other office equipment.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

Ipsen Bioscience, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law.

Ipsen Bioscience, Inc. conducts background screening, reference checks, and drug testing as part of its pre-employment screening process. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned.

All Employees are expected to adhere to all company policies and act as a role model for company values.

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.