Regulatory Affairs Director

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Introduction to role:
Are you ready to lead the charge in regulatory affairs and make a significant impact on global health? As a Regulatory Affairs Director (RAD), you will provide strategic and operational regulatory leadership for the development, commercialization, and lifecycle management of assigned products. You will serve as the global regulatory lead (GRL) on early-stage projects or specific indications of larger programs, or as a regional regulatory lead. Your role will be pivotal in influencing regulatory authorities through regular interactions to enhance regulatory outcomes. You will lead cross-functional teams in major regulatory submissions, health authority interactions, label discussions, and securing NDA/BLA approvals. As a GRL, you will guide the Global Regulatory Strategy Team (GRST) in formulating global regulatory strategies and delivering on NDA filings and approvals. Alternatively, as a regional regulatory lead, you will provide region-specific regulatory strategy and advice. You will be the face of the company with health authorities, driving innovation and excellence in regulatory affairs.

**Accountabilities**:

- Lead the development and implementation of regional or global regulatory strategies for products, ensuring rapid approval with competitive labeling.
- Drive cross-functional teams in major health authority interactions, from strategy formulation to meeting moderation.
- Lead the Global Regulatory Strategy Team (GRST) in planning and implementing regulatory strategies.
- Represent Regulatory Affairs on Global Product Teams (GPTs), providing strategic advice and overseeing all regulatory activities.
- Achieve regulatory achievements, evaluate regulatory success probabilities, and spearhead preparation of strategy documents and product labeling.
- Initiate and deliver key regulatory documents, negotiate with health authorities, and manage emerging data assessments.
- Ensure global dossier planning and product maintenance compliance.
- Collaborate with marketing companies and regional staff to influence developing views and guidance.

**Essential Skills/Experience**:

- At least 5-year experience of regulatory drug development or equivalent, and experience with major Health Authority interactions. Prior experience with phase 3 design including end of phase 2 health authority interactions is desired. Contribution to a regulatory approval including leading response team and labeling negotiations would be a plus.
- A solid knowledge of regulatory affairs within at least one therapeutic area in early and late development.
- Demonstrated proficiencies in critical thinking, critical influencing, innovation, initiative, leadership and excellent oral and written communication skills.
- The ability to think strategically and critically and evaluate risks to regulatory activities.

**Desirable Skills/Experience**:

- An advanced degree in a science related field and/or other appropriate knowledge/experience.
- A good understanding of guiding principles in drug development such as benefit/risk profile, dose selection or statistical design.
- Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs. Experience in relevant therapy area (small molecules & biologics) is preferred.
- Ability to work strategically within a complex, business critical and high-profile development program.
- Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical components.

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