Regulatory Affairs Associate - II in US-Remote

  • Title: Regulatory Affairs Associate - II
  • Code: RCI-12647
  • RequirementID: 105325
  • Location: US-Remote
  • Posted Date: 01/25/2023
  • Duration: 12 Months
  • Salary ($): 33.91 - 36.07 per Hourly
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  Job Description

Job Title: RA CMC Associate Level II - Regulatory Affairs CMC

Full-time role that requires the candidate to be local in the Pacific Time Zone, on-site and hybrid role preferred.

Remote is acceptable only to West Coast time-zone applicants.

Candidate must meet current client COVID Vaccination requirements before the start date

Specific Job Responsibilities:

Participates in preparing moderately complex CMC regulatory submissions under direction of a senior Regulatory Affairs professional which require some interactions with other members in the Regulatory CMC department and technical teams as well as senior stakeholders for investigational and commercial products in line with US and ICH requirements, regional requirements and scientific and company policies and procedures.

  • Works to develop and acquire required regulatory skills and basic CMC knowledge, with guidance from immediate supervisor.
  • Assist with miscellaneous US RA CMC team-related administrative documentation/tracking and product maintenance activities. Performs workflows and procedures regarding document tracking, indexing, and retrieving, and disseminating information to the Regulatory Affairs CMC department.
  • Participates in group meetings and provides tactical approaches to addressing issues of moderate complexity and seeks assistance from appropriate internal and external resources.
  • Work cross-functionally within a matrixed organization.
  • Must work well under deadlines and have excellent attention to detail in alignment with project goals and regulatory submission timelines.
  • Strong computer and organizational skills required.
  • Excellent verbal and written communication skills and interpersonal skills are required.

Education & Experience:

  • A Bachelor’s Degree with a minimum of 2+ years of relevant training or industry experience preferably in a GMP environment, OR 1+ years relevant training and industry experience preferably in GMP environment with advanced degree.

About Rangam:

Rangam Consultants is a minority, women-owned, disability workforce solutions global organization. Specialized in attracting and retaining talents globally for a rewarding career in IT, Engineering, Scientific, Clinical, Healthcare, Administrative, Finance, Business Management, and many more, while integrating veterans and individuals with disabilities into the workforce. Indeed, we connect career aspirants to relevant job opportunities, be it jobs in USA, UK, India, or Ireland. Also remote jobs, work-from-home jobs, or contract jobs in different verticals and industries.
Rangam strives to put job seekers first, giving them free access to search for jobs, post resumes, and research companies.Every day, we connect millions of people to new opportunities.