Regulatory Affairs Manager

Pay 65-70/h depending on experience

OVERVIEW: Regulatory Affairs

The Global Regulatory Affairs (GRA) is responsible for obtaining approval for new products and ensuring that approval is maintained throughout the product lifecycle. GRA serves as the interface between the regulatory authorities and the program teams aiming to ensure that the project plan correctly anticipates what the regulatory authority will require before approving the product. It is the responsibility of GRA to keep abreast of current legislation, policies, guidelines and other regulatory intelligence. The RA department plays an important role in giving advice to the program teams on how best to interpret the regulatory legislation and guidelines.

The Regulatory Affairs Nonclinical / Clinical team plays a key role in defining the regulatory strategy and pathway for a product by leading the development and execution of the nonclinical / clinical regulatory strategy and plan in alignment the overall clinical development plan. This team will take a lead role in planning and developing relevant sections of regulatory filings required for product approvals. In addition, this team will lead planning, coordinating and engaging directly with Health Authorities before, during and after regulatory approval milestones.

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