Director or Senior Director Regulatory Lead Immuno Oncology

Act as responsible for establishment of Global Regulatory strategy and pathway for one/several projects in Immunology/oncology.

Responsible for defining the annual regulatory roadmap, developing, owning and executing the global regulatory strategy.

The individual will interact cross-functionally to create high quality global regulatory submissions that support development strategies for products under the Oncology portfolio.

Specific Responsibilities:
• Understand key features of the product(s) and regulatory environment in oncology across major markets (disease and development guidelines, regulatory precedencies) and discuss accordingly the advantages and drawbacks of potential regulatory strategies throughout the development and lifecycle of the product(s), including approval pathways (g., accelerated pathways, orphan, legal basis,...) and regulatory requirements (e.g., PIP/PSP, CMC...) to support global development and regulatory strategy.
• Accountable for defining, updating, communicating and leading the global regulatory strategy for the product(s) in collaboration with internal stakeholders for input on specific market requirements, where needed (regulatory strategy to focus on agreed major markets) and for writing the Regulatory Strategy Document.
• Define the strategy for major Health Authorities interactions (EMA, FDA, PMDA, CDE) on the product(s) in coordination with/supporting region leads acting as primary point of contact of the HAs (GRL may act as the HA contact for US).
• Lead content creation cross-functionally for all regulatory documentation (g., core briefing book, slide set, Q&A, PIP/PSP...) and contribute to HAs interactions to support region heads/LRA acting as primary point of contact of the HAs (GRL may act as the HA contact for US).
• For clinical trials:
• Ensure alignment key documentation for clinical trials with the product strategy
• Ensure that the regulatory requirements necessary for the implementation of the study are available
• Ensure that the objectives set by the development plan are respected in the protocols/amendments
• Lead regulatory impact assessment in case of new findings (quality, efficacy or safety)
• Accountable for label development (e : Product information) and Company Core Data Sheet (CCDS)
• Participates as a core member of the product core team(s)
• Acts as the primary point of contact for all internal Company communication regarding the status of the project on issues related to regulatory process, regulatory strategy and delivery
• Lead the product(s) regulatory sub-team(s), bringing together all the key Reg Affairs members (Regional Reg, CMC Reg, submissions management, labelling, CTA/IND, as needed)
• Business partner regulatory counterpart (e.g. in-licensing partners...) as the case may be
• Interface with IVDD manufacturer(s), as the case may be

Qualifications:
• Strong regulatory strategic skills and ability to be successful in a multi-faceted environment -MUST have Immuno Oncology experience
• Knowledgeable in ICH, FDA and EMA guidelines and requirements
• Strong analytical skills
• Experience working collaboratively in multi-functional teams, network and alliance building
• Well organized, scientifically driven, pragmatic and open
• Excellent critical thinking and problem-solving skills
• Comfortable with and capable of prioritizing multiple tasks, projects and objectives
• Able to exercise discretion and confidentiality in a consistent and professional manner
• Strong verbal and written business communication skills
Skills and Education:
• Bachelors degree required with M/S, Pharm D, PhD/MD preferred
• Minimum of 5+ years' experience in managing regulatory process and registration aspects of the drug development process
• Previous experience in a regional/country regulatory manager role for several products in different therapeutic areas and in different stages of the product life cycle is highly desirable. Equivalent experience, either at a regulatory agency, or in another drug development role where the individual has experienced the regulatory process, will also be considered.

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