Manager, Regulatory Cmc Device Lead

vor 23 Stunden

Baar, Schweiz Biogen Vollzeit

Job Description**
Why Biogen?**

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
**About This Role**

This individual contributor role will be responsible for providing global Regulatory Affairs support for a variety of Biogen Medical Device and Combination Product programs as a part of the Regulatory CMC organization, with a focus on single-entity combination product development (pre-filled syringes and auto-injectors). Such support is critical to the clinical and commercial success of a variety of key Biogen assets and, as such, this will be a visible role within the organization and wider company.

Additionally, the individual will be responsible for:

- Developing and executing regulatory strategies for the medical device and combination product aspects of various programs.
- Coordinating and writing applicable regulatory documentation, submissions, and maintaining applicable regulatory compliance, specifically for NDAs and BLAs.
- Representing the Regulatory CMC Device team and working with others across the organization, company, and with external partners.
- Participating in regulatory intelligence and policy activities including interfacing with regulators, sitting on applicable industry working groups, as well as monitoring and communicating regulatory developments.
**What You’ll Do**
Monitor regulatory requirements and ensure compliance within scope of responsibility.
- Support Regulatory CMC Device team in the development of internal relationships with key functions.
- Support corporate objectives in establishing external relationships via industry organizations and with regulators.
- Provide regulatory input at the project team level.
- Identify, assess, and propose mitigations for regulatory risks associated with the execution of regulatory strategies in assigned regions.
- Develop and improve applicable Regulatory processes and procedures to support corporate goals and objectives.
- Monitor legislative and regulatory developments in the assigned area and inform pertinent cross-functional team members.
- Coordinate the preparation of the regulatory submissions, including engagements and responses to questions from Regulatory Authorities.
- Prepare and deliver effective presentations for internal audiences.
- Demonstrate strong organizational skills, including the ability to prioritize personal workload.
- Exhibit strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, drug safety, scientific, development, quality, and manufacturing staff.
**Who You Are**

Someone who has in-depth understanding of regulatory function within a business environment with appreciation of how Regulatory interfaces with multiple functional areas.

Qualifications**
Required Qualifications**:

- Bachelor’s degree.
- 3+ years of Medical Device and/or Combination Product Regulatory Affairs experience in a similar or more junior role.
**Preferred Qualifications**:

- Bachelor’s degree with a focus in Life/Health Sciences or Engineering.
- Experience with drug delivery systems (pre-filled syringes/auto-injectors.

Additional Information
All your information will be kept confidential according to EEO guidelines.

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