Manager Regulatory Cmc

Vor 3 Tagen

Zug, Schweiz Seagen Vollzeit

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us

Summary:
The Manager, Regulatory CMC supports a senior regulatory professional by executing against the global regulatory plan for one or more products. This position represents Regulatory CMC on cross-functional teams and manages the development and preparation of regulatory documentation to regulatory authorities.

**Responsibilities**:

- Provide regulatory representation at cross-functional and partner team meetings, including tactical support and timelines
- Communicate regulatory policy to product development teams and provide clarity on regulatory expectations and timelines
Assist in preparation for regulatory authority interactions and participate in regulatory authority meetings
- May function as primary liaison with regulatory authorities for routine communications in support of submissions for commercial products
- Work with partners and contract research organizations for ex-US regulatory submissions

Qualifications:

- Biotechnology experience preferred
- Solid knowledge and understanding of the drug development process and regional regulatory requirements
- Experience in the preparation/submission of regulatory documentation to support regulatory submissions
- Excellent oral and written communication skills
- Strong technical/analytical skills to identify and solve problems independently
- Proven ability to manage multiple projects, identify and resolve regulatory issues
- Willingness to work collaboratively
- Self-motivated, assertive, and self-confident
- Strong organizational skills to maintain a high level of productivity, prioritize work and coordinate work done by matrixed teams
- Ability to work under pressure, meeting time sensitive deadlines, while maintaining a high level of quality
- Proactively seeks out innovations for regulatory submissions and recommends process improvements
- Enjoys working in a fast-paced environment
- thorough understanding of local compliance, as well as a sound ethical approach to business

**Education**:

- BSc and +5 years regulatory experience; advanced degree (MSc, PhD, PharmD) and +2 years desirable-
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