Regulatory Affairs Manager, Remote

SUMMARY DESCRIPTION

The Manager supports Global Reg Teams in the development and execution of global nonclinical / clinical regulatory strategies through a program’s lifecycle. The Manager leads the execution of delegated activities, including preparation for HA interactions and the preparation of regulatory submissions in support of the strategy.

KEY RESPONSIBILITIES:

The RNC Manager responsibilities may vary depending upon product regulatory lifecycle and may include the leadership of selected activities which will be delegated by the Regulatory Nonclinical/ Clinical Lead and may include the following:

Development Stage Product

• Support the development of the nonclinical / clinical regulatory strategy and plan.

• Assist with selected planning, document development and meeting execution activities in preparation for HA meetings / interactions.

• Participate in Study Execution Teams for assigned products and identify relevant regulatory considerations for discussion with RNC Lead.

• Collaborate with CROs that are contracted to perform regulatory submissions/HA interactions for global clinical trials.

• With oversight by RNC lead, develop and coordinate the core nonclinical / clinical content of regulatory submissions.

• Responsible for ensuring high quality nonclinical/clinical content that adheres to regulations and guidances.

• Lead the maintenance of IND/CTAs throughout the life of the studies (e.g., annual reports)

• Assist with the preparation of HA submission packages including but not limited to compiling relevant materials (Protocols, Annual Reports, Briefing Books, etc.) and completing regulatory documents/forms for internal review.

• Collaborate with Reg PM to create and align submission timelines,

• Collaborate with Reg Ops to provide final documents and QC published outputs for submissions to HA.

• Oversee the collaboration of Nonclin/clin with Reg Ops to provide final documents and QC published outputs for submissions to HA.

• Organize and maintain the administrative, nonclinical, and clinical portions of IND’s, NDA’s and BLA’s.

• Oversee the archiving of HA submissions and correspondence

Commercial Stage Product

• Lead the development of updates to the clinical and nonclinical sections of the core dossier used for INTL marketing applications.

• Provide support to RNC lead on development of nonclinical / clinical portions of required product lifecycle maintenance regulatory submissions, examples are: clinical or nonclinical supplements to approved US product dossiers and any required annual reports, license renewals, supplemental filings.

• Coordinate necessary interactions with INTL in support of INTL MA filings. Examples include: meetings to provide RNC guidance/input on agency interaction, submissions, RTQs.

General

• Attend relevant functional area and project team meetings.

• Review, understand and stay up to date on regulations, guidelines relevant to responsibilities

• Review documents (SOPs, protocols and reports) related to Clinical or Nonclinical studies as necessary

• Ensure that the PM timelines and tracker accurately reflect submission plans

EDUCATION AND EXPERIENCE

• Degree in health or life sciences, including chemistry, molecular biology, or similar. PhD preferred, Masters/Bachelors acceptable with relevant experience

• 4 + year experience

• Nonclinical / Clinical Regulatory Affairs experience preferred