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Senior Regulatory Affairs Specialist

2 months ago

Thousand Oaks, California, United States Aditi Consulting Full time
Overview:
The Senior Regulatory Affairs Specialist (CMC) plays a crucial role in providing comprehensive support to the regulatory Chemistry, Manufacturing, and Controls (CMC) division, across various regions and stages of product development. Responsibilities may encompass the organization, management, and execution of regulatory CMC initiatives to facilitate regulatory submissions. Duties include document formatting according to established guidelines, data retrieval and organization from regulatory databases, drafting of meeting agendas and minutes, overseeing document reviews, and other related tasks as assigned.

Key Responsibilities:
  • Focus on delivering submission execution assistance for products across different modalities, regions, and development phases.
  • Collaborate closely with project teams to support submission execution efforts.
  • Contribute to projects that positively influence essential company processes, ultimately benefiting the development of human therapeutics and the patients who rely on them.
Qualifications:
  • Exceptional organizational abilities with a keen eye for detail.
  • Strong time management skills with the capacity to prioritize tasks effectively.
  • Able to work independently as well as collaboratively within a team environment.
  • Proficient in Microsoft Office suite, particularly Word, Excel, PowerPoint, and Project.
  • Eligible to work in the U.S. without the need for employer sponsorship.
Experience Requirements:
  • Master's degree with 2 years of experience in Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical, or related scientific fields; OR Bachelor's degree with 4 years of relevant experience; OR Associate degree with 6 years of relevant experience; OR High school diploma/GED with 8 years of relevant experience.
Preferred Skills:
  • Degree in life sciences, biochemistry, or chemistry.
  • Experience within the biopharmaceutical or pharmaceutical sectors.
  • Familiarity with eCTD structure.
  • Self-motivated with a strong desire to learn rapidly.
  • Experience in CMC, including the preparation of submissions to regulatory agencies.
  • Proficient in Microsoft Office suite, especially Word, Excel, PowerPoint, and Project.
Essential Skills:
  • Experience in Manufacturing and/or Quality Assurance.
  • Highly organized.
  • Adaptable and flexible.
Compensation:
The compensation range provided is the base hourly pay range that Aditi Consulting anticipates for this position. Actual compensation may vary based on several factors, including the candidate's qualifications, skills, experience, location, and client requirements.

Benefits:
Eligible employees may have access to medical, dental, vision, PTO benefits, and other ancillary benefits, which may vary based on the selected plan options.