Manager, Regulatory CMC Device Lead

Job Description

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.

WhatYou’llDo
  • Implement regulatory strategies for new registration submissions and post-approval applications.
  • 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.


Qualifications

Required Skills
  • 3+ years of Medical Device and/or Combination Product Regulatory Affairs experience in a similar or more junior role. Experience with drug delivery systems (pre-filled syringes/auto-injectors) preferred.
  • BS University degree required, Life/Health Sciences or Engineering preferred.
  • 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
  • Understand application of cGMP for Medical Devices and Combination Products.
  • Very strong technical and influential writing ability.
  • Strong analytical abilities.




Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.

861639356