Early Development Regulatory Manager

vor 2 Wochen

Basel, Schweiz Manpower Vollzeit

Mandated by one of our client companies, we are currenlty looking for a Regulatory Affairs Manager. The person in this role works with some independence under limited supervision to provide operational and strategic regulatory leadership for early development (ED) programs.

**General information**:

- Workload: 100%
- Duration: 12 months
- Remote work: No, ideally on-site position in Basel, occasional HO according to company policy

**Your mission** Responsibilities**:
**Regulatory Strategy**:

- Responsible for managing operational activities of assigned early development projects.
- Responsible for organizing and planning submission team meetings, driving regulatory timelines and with input from the EDRDs and franchise DRA may lead key messaging for ED submissions and HA responses.
- Provides input into global regulatory strategy and contributes to the Integrated Development
- Plans (IDP) and early Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions.
- Partners with regions and franchise DRA to align on regulatory strategy for ED programs, assuring full awareness of franchise and regional experts in plans and timing for programs to move to PoC and full development.
- Works with the ED DRA Head and EDRDs to plan and facilitate presentations to regulatory boards on regulatory strategy.
- Works with DRA ED Head, EDRDs and/or GTAL in the relevant therapeutic area to obtain needed external input from consultants and advisors for specific program challenges.
- Represents DRA on or leads sub-teams as required.HA Interactions:

- Works with EDRDs to determine requirements and set objectives for Health Authority (HA) interactions.
- Interacts directly with HAs as appropriate in meetings with input and support from DRA EDRDs or franchise leadership.
- Coordinates and plans rehearsals for HA meetings.
- Develops and implements plans for timely response to HA requests and coordinates responses.
- May serve as local HA liaison depending on location (e.g., FDA or EMA).

**Submissions and Approvals**:

- Responsible for managing timely submission and approval of dossiers with HAs under the guidance of the DRA ED Head, keeping franchise head/GTAL in the disease area in the loop.
- Responsible for submission of Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs), and CTA/ IND related maintenance activities such as amendments, annual safety reporting, end of trial notifications, submission of CSR etc.
- Contributes to identification of issues, gaps, and tradeoffs affecting optimal and timely submission and approval.
- Review and comment on key messaging and integration of early submissions, IBs and other summary documents.
- Participates in negotiations with HA to address queries on INDs and CTAs.
- Regional Excellence and Compliance:

- Responsible for collaboration with Region and Country DRA to provide regional input into IND / CTA filing strategy.
- Responsible for appropriate entering and quality of product specific attributes in compliance database.
- Ensures regulatory compliance for assigned project and keeps records of all major HA interactions in the validated document management system.
- Ensures quality and compliance with global regulatory requirements and adherence to regulatory internal policies and processes.
- Provide support as needed for non-project related regional excellence activities.

**Your profile**
- Swiss and/or EU nationality or an already existing and valid work permit for Switzerland
- **Ideal Background**:

- Education(minimum/desirable): Science based BS or MS with requisite experience and demonstrated
- capability. Advanced degree (MD, Ph D, PharmD) is a plus. Background in basis science or toxicology is preferred.
- Languages: Fluency in English as a business language. Additional language is an asset.
- **Experience**:

- Experience with regulatory submission and approval processes in 1 or more major regions.
- Experience in a global/matrix environment or cross-functional teams in the pharmaceutical industry.
- Experience in HA negotiations.
- minimum of 2-4 years involvement in regulatory and drug/biologic development spanning activities in Early Development and Phases I-IV.
- Strong interpersonal, communication, negotiation and problem solving skills.
- Experience in the following areas will be helpful.
- Innovation in regulatory strategy.
- Research experience in biology, pharmacology, toxicology, DMPK or Chemistry.
- Experience with biologics is a plus.
- Analysis and interpretation efficacy and safety data.
- Regulatory operational expertise.
- Basic organizational awareness (e.g., interrelationship of departments, business priorities).

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