Associate, Regulatory Affairs (Contract)
Department: Regulatory CMO/ Clinical
Employment Type: Contractor
Reference Number: 2576309
Job Description Summary
The Regulatory Affairs Associate provides key support to the Regulatory Affairs department. This position has primary responsibility for coordination and assembly of regulatory documents for review and submission to health authorities (primarily the FDA, other regulatory agencies as needed). The Regulatory Affairs Associate will ideally have some working knowledge of regulatory requirements specific to key regions such as the US, Canada, and EU, and have a general awareness of current global trends in Regulatory Affairs. In addition, excellent verbal and written communications skills are required.
- Under the direction of a senior Regulatory staff member, prepare, compile review, and submit documents for the company, including but not limited to initial INDs/CTAs/NDAs and amendments or supplements.
- Assist regulatory management and project teams in the implementation of regulatory plans and timely delivery of regulatory documentation.
- Develop, maintain, and communicate timelines for regulatory submissions.
- Participate in the review of critical documents such as: protocols, ICFs, IBs, CSRs, DSURs, etc. to ensure they are compliant with relevant regulations and guidance (e.g., ICH, FDA, EMA, etc.) prior to submission.
- Coordinate with other departments (i.e., Clinical, Nonclinical, CMC) and Regulatory Operations to gather and assemble information necessary for submissions to health authorities in accordance with regulations and guidelines.
- Maintain databases of regulatory information, submissions and correspondence.
- Follow general instructions to complete projects while independently planning daily work to complete time sensitive assignments.
- Review documents required as part of the Regulatory Site Documentation for the shipment of drug product to the clinical sites.
- Review ClinicalTrials.Gov Postings and serve as a system administrator.
- Maintain current knowledge of applicable US and global regulations, guidance, and standards for drug development and product registration.
What is Required
- A minimum of a BS in life sciences
- Understanding of the drug development process and knowledge of global guidance and regulations.
- Excellent oral and written communication skills.
- Time management skills are essential.
- Ability to work on multiple tasks to meet company objectives.
- Strong attention to detail.
- 1 year of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries (an equivalent combination of education and experience in pharmaceutical drug development, biotech or related field may be considered).
- Has successfully supported health authority submissions or similar deliverables and critical projects while maintaining agreed timelines.
- Previous experience with IND filings and/or experience with eCTD formatted submissions desirable.
- Demonstrated ability to work effectively with cross-functional teams e.g., research, clinical, and CMC teams.
- Ability to implement regulatory plans and strategies and proactively identify risks.
- Knowledge of 21 CFR and FDA, ICH, GCP, GMP, eCTD, and global guidelines.
- Excellent Computer Skills MS Word, Excel, Power Point, and document management software/system.
- Previous experience with building electronic submissions in compliance with Health Authority requirements is a plus.
- Previous experience with maintaining in house repository for archiving regulatory submissions and Health Authority correspondence in 21 CFR Part 11 compliant system (e.g., Veeva) is a plus.