Regulatory Affairs Specialist II (CMC)
Responsible for supporting the Regulatory Affairs Department across a number of company-sponsored projects. Primarily responsible for manufacturing and analytical areas of product development activities. This job contributes to and supports the company’s research and development efforts to create high value therapeutics to address unmet medical needs.
Essential Duties and Responsibilities:
Works on problems of diverse scope within the manufacturing and analytical areas of product development in which analysis of data require an evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Under the direction of senior regulatory affairs staff, assists in the strategic development, authoring, editing and processing of regulatory submissions for Company and partner sponsored global regulatory Chemistry, Manufacturing and Controls (CMC) submissions.
- Locates and obtains supportive information necessary for CMC product development in accordance with regulations and relevant guidelines.
- Through formal and one-one training, becomes familiar with the laws, regulations and guidelines governing drug development and approval.
- Under the direction of senior regulatory affairs staff, maintains regulatory submissions, correspondence, and commitments for Company sponsored projects, and all Company related Module 2.3 and 3 eCTD sections for Company and partner sponsored projects.
- Under the direction of senior regulatory affairs staff, provides input on timelines for submissions.
- Follows general instructions to complete projects. Organizes workday to complete mid-term assignments. Supports other projects as needed, which will include but not be limited to performing research and compiling materials to develop regulatory strategies.
Minimum Qualification Requirements:
A minimum of a Bachelors degree in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 2 years related industry experience is required. A minimum of 1 year hands-on Regulatory Affairs experience in CMC is preferred. Organizational, planning and follow-up skills, as well as word processing skills are required. Must be able to demonstrate a good attention to details and be goal-oriented, and quality conscientious. Strong computer skills in Word, Excel and Adobe Acrobat. Ability to use the Internet for research applications is required. Expected to gain understanding of current US regulatory requirements, guidelines and regulations. Strong oral and written communication skills are required. Must be able to adapt to changing priorities and manage multiple tasks.