Associate Principal Scientist, Regulatory Affairs

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

We are currently looking for an experienced Associate Principal Scientist, Regulatory Chemistry, Manufacturing and Controls (CMC) to be based in our new office in Zürich.

Under direction from Director/Executive Director, the Associate Principal Scientist is responsible for implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance with domestic and international regulations and guidance. The Associate Principal Scientist is responsible for the preparation and submission of CMC sections for commercial or new biologics products. The Associate Principal Scientist will assist in or be part of team that is responsible for development and the implementation of internal regulatory strategies and provides mentoring and coaching to Senior Scientist or Scientist in support of their assigned projects.

**Responsibilities**:

- Participation in the authorization process to prioritize submissions.
- Completion of detailed, global regulatory assessments according to existing global guidelines and policies and defined timelines.
- Development and execution of detailed, global regulatory strategies for submission and approval of INDs, BLAs or post approval change documentation according to defined timelines.
- Careful planning, tracking and communicating regarding submissions and approvals to support continued product supply.
- Lead authoring of clear, concise and effective submissions according to defined timelines.
- Collaborate with partner groups in the authoring and reviewing process to ensure compliance, scientific excellence, accuracy and completeness of submissions.
- Resolve project issues through collaboration with the team and escalation to the CMC leadership team as appropriate.
- Participation in early and late development programs, as well as departmental and cross-functional efforts to improve CMC content or processes may also be required, as needed.

**Your Profile**:

- Bachelor in a science, engineering, or a related field such as Pharmacy, Chemical or Biological Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry.
- Advanced degree would be strongly preferred.
- A minimum five years of Industrial/regulatory experience in biologics research, development and/or manufacturing.
- Fluency in English (oral and written).
- Demonstrated sound understanding of related fields (e.g., manufacturing, process development, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
- Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly, and conclusions are adequately supported by data.
- Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner.
- Demonstrated effective leadership, project management, communication, interpersonal and negotiating skills.
- Experience with clinical submissions, or post approval changes in Biologics and experience in Device Development or Vaccines is a plus.

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

**THE COMPANY**

Our company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility,

Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations

(Tribschenstrasse, Citybay, Schachen and Kriens). A fifth location has been recently established in Zurich, aimed at

accelerating the development and commercialization of many of our company’s medicines and vaccines, which supports our

mission to save and improve lives around the world. The new location has a target date of 2021 for operational readiness.

We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s

commitment to our employees and the community around us.

The recently opened new location in Zurich focuses on accelerating research, data and commercialization of our medicines

and vaccines. The new office will be staffed by teams working in strategic and operational roles in medical affairs, clinical

de