Associate Director, Regulatory Cmc

Vor 7 Tagen

Zug, Schweiz Seagen Vollzeit

Position Summary:
Principal Responsibilities:

- Provide effective strategic and tactical leadership to support global regulatory plans including:

- Conducting regulatory review of documents for health authority submissions
- Representing the regulatory function on cross-functional teams and communicate regulatory requirements to ensure optimal execution of the regulatory strategy
- Providing regulatory guidance and strategy including identifying and assessing regulatory risks
- Serving as point of contact with regulatory authorities, as applicable
- Monitoring and researching regulatory intelligence, to bring innovative approaches to the cross‑functional team and maintain knowledge of the regulatory landscape to pro-actively assess impact of changes on development plans
- Collaborating with global development partners

Qualifications:

- Minimum of 8 years Regulatory CMC experience; advanced degree desirable
- Biologic product experience highly desirable
- Ability to oversee regulatory activities and manage process from research/discovery, clinical development through to commercialization and post-marketing maintenance
- Knowledge and understanding of global regulations and guidelines
- Familiarity with FDA IND/NDA/BLA, National European (Swiss, UK, others) regulatory processes
- EU Centralized Procedure expertise required (preferably an MAA, or as a minimum, major Type II Variations for new indications)
- Knowledge of EU procedures (fast to market procedures would be an advantage)
- Experienced with CTA submissions and maintenance, as well Scientific Advice
- Experience leading a team to prepare for and carry out major health authority interactions
- Line management experience advantageous
- thorough understanding of local compliance, as well as a sound ethical approach to business

**Education**:

- PhD, PharmD, Masters or Bachelors degree in life sciences
- #LI-LO1_

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