Regulatory Affairs Senior Associate #JN -052021-63822

Thousand Oaks, California
Industry: Regulatory
Job Number: JN -052021-63822

Any archival system experience would be great

regulatory related experience or degree, communication, prioritization

Entry Level

 

Description:

  • Clients are seeking a Regulatory Affairs Senior Associate supporting products in the Oncology Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all molecules.
  • In this role you will assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization. The purpose of Regulatory Affairs Senior Associate is:
  • To coordinate and execution of US regulatory submissions with the US Regulatory Lead in compliance with corporate standards and local regulatory requirements.
  • To manage and execute of the preparation, delivery and electronic archiving of documentation for inclusion in US regulatory submissions
  • To assist the Global Regulatory Lead to manage GRT interactions

 The responsibilities of the Regulatory Affairs Senior Associate position are:

  • Assist US Regulatory Lead to support regional regulatory activities (e.g. IND submissions and agency meetings)
  • Provide and maintain CTA/MA documentation support (e.g. initial filings, amendments, and periodic reports) in collaboration with Regional Regulatory Lead
  • Create and maintain product regulatory history documents through systems and appropriately archive all regulatory documents and agency communications
  • Review regional component of the Global Regulatory Plan and provide input to operational deliverables
  • Collaborate with CRO’s / partners to support site initiation
  • Coordinate collection of functional documents in support of regulatory filings
  • Participate in GRT to support execution of regulatory strategy
  • Coordinate QC of regulatory documentation (e.g. briefing materials)
  • Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
  • Prepare regulatory packages and cross-reference letters to support investigator initiated studies
  • Complete regulatory forms to support agency communications
  • Provide regulatory support through cross-functional interactions in work package teams (eg, commercial and evidence generation teams)
  • Support process improvement initiatives, standards development, and metrics
  • Assist in template development and maintenance
  • Respond to specific requests from and communicate relevant issues to GRT
  • Develop Regulatory Position with GRT
  • Actively support regulatory compliance
  • Support the development and execution of GRT goals

 Basic Qualifications:

  • Doctorate degree Or
  • Master’s degree in a biology, life science, health science curriculum, or regulatory science with biology curriculum Or
  • Bachelor’s degree and 2 years of Regulatory experience

 Preferred Skills:

  • Strong communication skills - both oral and written
  • Ability to understand and communicate scientific/clinical information
  • Ability to resolve conflicts and develop a course of action
  • Cultural awareness and sensitivity to achieve global results
  • Planning and organizing abilities
  • Able to prioritize and manage multiple activities
  • Ability to deal with ambiguity
  • Organizational savvy
  • Negotiation skills

 


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