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Regulatory Operations Associate

Location: Cambridge Salary: competitive
Sector: Pharma & Biotech, Regulatory Affairs Type: Contract

Our client is seeking a Regulatory Operations Associate to join their team on a contract basis. This is a long term position looking to last over 12 months.

OBJECTIVES:

  • Plans/manage/executes all regulatory submission and assigned compliance activities of all levels of complexity for vaccine development and marketed products in VBD.
  • Furnish technical and subject matter expertise of all publishing software/tools and processes for the production and oversight of regulatory submissions.
  • Participates on planning teams to develop and manage timelines associated with regulatory submissions.
  • Ensures regulatory submissions maintain compliance and quality according to internal or external timelines.
  • Understands and interprets regulatory guidance documents related to submissions.
  • Obtains alignment with other divisions and vendors to provide optimal publishing solutions to support global vaccine submissions.
  • Participate and provide vaccine requirements for broader regulatory compliance and quality management system workstreams to ensure vaccine compliance with regulations and company QMS, as appropriate.

ACCOUNTABILITIES:

  • Accountable for some writing and all compiling, reviewing, editing, submissions and document approvals for vaccine project(s) of responsibility.
  • Accountable for ensuring all other regulatory submissions within the assigned region or product are submitted on schedule by local company affiliates within vaccine project(s) of responsibility by ensuring the regulatory deliverables are provided as outlined in the global regulatory strategy.
  • Identifies regulatory submission requirements and provides regulatory submission guidance and expertise to GPT team on the assigned vaccine project(s) of responsibility.
  • Executes day-to-day activities for vaccine projects.
  • Identifies and notifies management of resource gaps for assigned vaccine project(s), when necessary.
  • Maintains responsibility for the planning and production of large complex regulatory submissions.
  • Participates on Regulatory Working Groups, as appropriate, to provide requirements and timelines associated with submission publishing.
  • Oversees publishing activities for projects in accordance with regulatory requirements.
  • Ensures compliance with all internal processes and SOPs related to submission tracking, submission forecasting and document tracking
  • Conducts and/or participates in final review of published submissions to ensure compliance to requirements.
  • Participates in evaluation and acceptance of vendor software utilized in production of regulatory submissions
  • Identifies and escalates risks to quality of submissions or adherence to submission timelines and engages appropriate representatives to manage outcomes.
  • Works with vaccine development and marketed product teams to ensure compliance with standards and regulatory guidance for documents used in submissions.
  • Maintain and track global regulatory commitments.

REQUIREMENTS

  • BS Degree, preferred. BA accepted.
  • Minimum of 5 years of pharmaceutical industry experience (preferably in biologics). This is inclusive of 3 years of regulatory publishing and submissions management experience or combination of 5 years regulatory and/or related experience.
  • 2-3 years in Vaccines industry preferred
  • Preferred experience in reviewing, authoring, or managing components of regulatory submissions.
  • Knowledgeable of IND and BLA/MAA and other global submission requirements
  • Understands and interprets global submission requirements as it relates to regulatory requirements and electronic standards for assigned vaccine projects.
  • Demonstrates acceptable skills in oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
  • Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory submission issues; offers creative solutions and strategies, including risk mitigation strategies.
  • Must work well with others and within global teams.
  • Able to bring working teams together for common objectives.

Sthree US is acting as an Employment Business in relation to this vacancy.