About This Role

As the Sr. Manager, CMC Regulatory Device Lead, you 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.

What You’ll Do

• Implement regulatory strategies for new registration submissions and post-approval applications.
• Monitor regulatory requirements and ensure compliance within scope of responsibility.
• Support the 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.

Who You Are

You are passionate about the regulation, design, and development of drug-device combination products. You have strong interpersonal and organizational skills, and the ability to prioritize workload and deal effectively with a variety of people and functions.

Required Skills

• Minimum of BS Degree and 5+ years of regulatory experience, ideally in the pharma/biotech industry
• In-depth understanding of regulatory function within a business environment with appreciation of how Regulatory interfaces with multiple functional areas.
• Awareness of applicable core legislation, regulations, guidance, and standards.
• Strong analytical abilities.

 Preferred Skills

• Life/Health Sciences or Engineering degree
• Experience in Medical Device and/or Combination Product Regulatory Affairs experience in a similar or more junior role.
• Understand application of cGMP for Medical Devices and Combination Products.

Additionally, you 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.

You will be 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.

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