Director, Global Regulatory Affairs, Oncology

Summary / purpose of the position

To be accountable for the strategy, tactics and implementation of all regulatory aspects of the assigned programs and all of its components for assigned region or worldwide.

To provide regulatory expertise to RD, Franchise and Commercial Operations for assigned products/projects.

Act as the interface between the RD/Franchise/Operations and GRA on all regulatory issues relevant to Development

and Product Maintenance activities within the assigned product/project.

To ensure the development and flawless execution of regulatory strategies for the assigned products/projects and all of its components (both development and marketed products) for assigned region or worldwide.

Responsible for Regulatory Intelligence for relevant disease area and to identify and then communicate the implication of upcoming trends that may impact the business.

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.

Lead operational excellence initiatives within GRA

Main responsibilities / job expectations

Overall Accountability

Accountable for the development, flawless execution and implementation of regulatory strategies activities for the assigned programs for assigned region or worldwide, working with RD, Franchise, Operations and within the regulatory science community to bring innovative and compliant approaches to the development and maintenance of 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 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; proposes remediation where possible.
• With RD, Franchise, Operations and 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 Ipsens ethics and compliance policies

Knowledge, abilities experience:

Ideal

• Proven experience of drug development and managing complex worldwide products/projects within a relevant therapeutic area, in key geographies.
• Track record of building excellent relationships with regulatory authorities FDA.

Minimum

• Advanced degree (or equivalent) in scientific discipline (not limited to Pharmacy, Medicine, Chemistry, Biological Sciences).
• Significant experience in the pharmaceutical industry, including minimum 10 years in Regulatory Affairs.

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