Regulatory Affairs Specialist in Torrance, CA at Volt

Date Posted: 3/23/2021

Job Snapshot

  • Employee Type:
  • Location:
    Torrance, CA
  • Job Type:
  • Duration:
    0 weeks
  • Date Posted:
  • Job ID:
  • Contact Name
    Volt Branch
  • Phone

Job Description

Job Title: Regulatory Affairs Specialist – Torrance Location

The RA Specialist will support the RA staff to ensure regulatory compliance across our clients product brands, which includes pre/post approval for generic and commercials APIs. 

Essential Functions:

• Demonstrated experience in preparing FDA, EMA CMC submissions in CTD format

• Knowledge of FDA, EMA and other global agencies’ regulations related to CMC submissions for generics and NCEs

• Perform quality work within deadlines with or without direct supervision

• Interact professionally with other employees, customers and suppliers

• Work effectively as a team contributor on given assignments

• Work independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizations

• Represent RA in cross-functional group meetings as designated by the RA product lead

• Providing regulatory CMC support, submissions and coordinating regulatory projects for contract drug substance manufacturing (API, generic and NCE)

• Research regulatory issues (e.g. monograph status) global regulatory guidance

• Be responsible for maintaining assigned technical files and CMC packages for both clinical phase products and approved PPL products

• Provide regulatory support to current PPL customer products as necessary including: reviewing of change controls, BPRs, QC methods and all CMC related materials

• Provide support to regulatory compliance activities, including drug listings, global facilities registrations and maintaining local/state site registration

• Perform other related duties as required and assigned

Job Requirements:

• Minimum Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical or other related sciences

• 3-5 years of relevant experience in the Pharmaceutical API, or API Fine Chemical Industry, in areas of Regulatory, Manufacturing or Quality

• FDA, EMEA and bulk chemical API cGMP experience

• Proficient in Microsoft Office Suite • Knowledge and understanding of API chemical synthesis, Quality Control and Quality Assurance

• Ability to read, analyze, and interpret professional journals, technical procedures, and governmental regulations

• Ability to write regulatory documentation and justifications, reports, business correspondence, and procedure manuals

• Ability to effectively present information and respond to questions from groups, managers, customers and regulatory agencies

• Contract manufacturing, drug substance and pharmaceutical experience

• Excellent communication skills and detail-oriented

• Experience coordinating teams on special projects

VOLT is an Equal Opportunity Employer.