Director, Regulatory Affairs - Biosimilars

11/19/21

Berkeley Heights, NJ

1459

This position will predominately have regulatory accountability across all biosimilar programs, will manage internal regulatory processes, and will develop regulatory capabilities/competencies within the business unit. Directs the regulatory activities required to support product development activities and to achieve marketing authorization for biosimilar programs. This position ensures timely communication, feedback and follows up with the FDA and is responsible for maintaining open communication with Senior Leadership as well as with employees within department.

Responsibilities:

  • Communication with the FDA either in person, by telephone or by letters. Notify upper management concerning FDA communications and application status.
  • Interpreting laws and guidance’s applicable to the development and operations and ensuring that these regulations are rolled out within the organization.
  • Advise internal customers with regulatory strategy and implementation plan for submissions and approved applications.
  • Oversees review and approval of documents {batch records, specifications, analytical methods, protocols, etc.) for regulatory compliance. Supervises the preparation of marketing applications and periodic reports.
  • Reviews and authorizes marketing applications and periodic reports to meet FDA’s current requirements.
  • Determine strategy to resolve deficiency questions from the Agency and path forward to complete additional activities to support responses. Develop path forward for submission of post approval changes which comply with regulations while meeting business needs. Review Deficiency response letters and post approval supplements for appropriate wording, terminology and presentation.
  • Advise customers how to prepare their marketing applications with particular emphasis on characterization information. This includes recommendations for regulatory strategies for submitting changes. Ensure continued growth by providing submission strategy improvements to meet the business needs.
  • Mainly responsible for pre-approval regulatory affairs activity. Will need to have strong knowledge of post-approval regulatory affairs.
  • Responsible for oversight of labelling program for products and contract as applicable.
  • Ensure that all of the PKPD & clinical studies necessary are conducted in a compliant and timely fashion to support approval of product. Review of clinical development plans, conduct and own/lead any necessary FDA meetings, and budgetary responsibility are also a requirement of this position.
  • Management of Compendia compliance program for timely notice and evaluation of changes as well as implementation
  • Hire, train, develop and discipline RA Staff. Train them with most current guidelines and laws so that each Associate can perform duties independently.
  • Management of workload and duties of the entire group - including close collaboration with project management on filing-to-approval timelines/cycles.

Qualifications:

  • Pharmaceutical, Chemistry or Regulatory degree required.
  • Minimum of 10 years in regulatory with progressive management
  • Expertise in Pharmaceutical Regulatory and FDA process and interface
  • Knowledge of FD & C Acts, other current related regulations, and FDA guidelines
  • Experience with submissions, BLAs and INDs. Working experience in clinical/bioequivalence studies and devices
  • Strong management skills
  • Effective problem-solving skills
  • Clear communication skills
  • Highly proactive
  • Decisive with strong interpersonal skills
  • Strategic thinking and commitment to timelines
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