Associate Program Manager (Regulatory)

South San Francisco, California | Contract

Post Date: 11/20/2015 Job ID: 1174 Industry: Quality and Regulatory Affairs

Duties: 

 
  • Expected to develop and maintain his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics.  Briefs teams and management, as appropriate
  • Obtains and applies in-depth knowledge of regulatory guidelines, procedures and best practices
  • Stays abreast of therapeutic area product development and other related business strategies and plans 
  • Supports on one or more regional projects at any one point in time
  • Participates in the development and implementation of the cross-functional regulatory strategy for each project or related assignment
  • Supports Regulatory Program Directors in identifying and aligning cross-functional regulatory resources necessary to execute the regulatory strategy for each project or related assignment
  • Supports Regulatory Program Directors and others in scheduling and preparing for meetings, teleconferences and other interactions/communications with regulatory authorities. Establishes effective working relationships internally and externally with regulatory authorities
  • Documents meetings, teleconferences and other interactions/communications with regulatory authorities
  • Supports Regulatory Program Management Program Directors in providing internal teams with direction on regulatory authority interactions
  • Participates in and supports management of ongoing RAFT meetings. Including providing ongoing guidance on regulatory deliverables, compliance, timing and other relevant matters. Helps manage RAFT resources, including documenting meeting minutes and conducting follow-up to ensure action items are completed in a timely and thorough manner
  • Helps manage project plans and timelines for assigned projects
  • As assigned, performs literature searches, prepares special reports and assembles documentation to support project teams
  • Supports Regulatory Program Management Program Directors with a first-line of internal approvals for regulatory submissions and other relevant regulatory documentation. Helps ensure that all elements, quality, accuracy and format of regulatory submissions and other documentation comply with applicable laws, regulations and Roche standards
  • Supports effective, best-practice maintenance of various clinical and non-clinical regulatory documents
  • Helps Regulatory Program Management Program Directors manage all PDR deliverables associated with each project or other assignment to ensure these are completed within defined timelines and meet regulatory and other company guidelines
  • Participates in and supports development of regulatory risk management and contingency plans. Develops associated communication plans for Regulatory Program Management Program Directors and their internal distribution  
  • Supports management of relevant project budgets to ensure compliance with agreed parameters and provides routine and ad hoc budget reporting and other updates
  • As requested or otherwise appropriate, supports Regulatory Program Management Program Directors in providing regulatory due diligence assessments in cooperation with other internal groups

 

 

Skills:    

 

  • Bachelor’s Degree required (life sciences disciplines strongly preferred)
  • Advanced Degree in related field is preferred
  • Some relevant experience in regulatory affairs or related functions in drug/biologics development/manufacturing is strongly preferred
  • Knowledge of, or aptitude to learn, international regulations, processes and issues in drug/biologics development. Includes GxP (Good Practices for quality guidelines and practices in the pharmaceutical/biotechnology or related industry), GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines
  • Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat
  • Fluent English and other language skills as needed
  • As required, ability to travel

 

Education:      

    

  • Bachelor’s Degree required (life sciences disciplines strongly preferred)
  • Advanced Degree in related field is preferred
  • Some relevant experience in regulatory affairs or related functions in drug/biologics development/manufacturing is strongly preferred
  • Knowledge of, or aptitude to learn, international regulations, processes and issues in drug/biologics development. Includes GxP (Good Practices for quality guidelines and practices in the pharmaceutical/biotechnology or related industry), GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines
  • Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat
  • Fluent English and other language skills as needed
  • As required, ability to travel
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