Pacific-Link Consulting, a San Diego based Regulatory Affairs consulting company, is seeking a full-time Regulatory Affairs professional with an expertise in CMC who will be responsible for planning and authoring high-quality CMC-related, as well as general regulatory submissions to the FDA in accordance with regulatory guidelines and applicable federal laws. If hired, the position will work remotely and report directly to the Sr. Director, Regulatory Affairs and Pharmacovigilance.
ESSENTIAL DUTIES AND PRIMARY RESPONSIBILITIES
- Preparing and writing a variety of high-quality submissions (i.e., Module 3 summaries, CMC-related Amendments and Supplements, Annual Reports, Meeting Requests, Briefing Packages, etc.).
- Critically reviewing documentation intended for submission to the FDA for internal consistency, for consistency to relevant FDA guidelines and to promote regulatory excellence.
- Participates in the establishment of submission timelines and ensure that the due dates for submissions are met.
- Communication regulatory CMC requirements for INDs/NDAs/NDSs/Amendments to team members, as well as clients.
- Minimum of 5 years experience in regulatory affairs.
- Minimum of a Bachelor’s Degree in a life or physical science.
- Preferred – Regulatory Affairs certification or Master of Science (M.S.) in Regulatory Affairs.
Required Knowledge, Skills, and Abilities
- Knowledge of 21 CFR, FDA, ICH guidelines, as well as GLP, GCP, and GMP environments.
- Proficient with Microsoft Office
- Excellent written and oral communication and technical writing skills.
- Excellent QC, editing, and formatting skills.
- Ability to write a variety of high-quality CMC submissions.
- Ability to manage and prioritize multiple projects.
- Ability to follow written and verbal direction with a high level of accuracy.
- Be self-motivating with the ability to work remotely, as well as in a team setting.
- Exceptional time-management abilities and strong follow-through skills required.
As an employee, you’ll enjoy our competitive compensation and benefits packages. We invite you to consider a career with Pacific-Link Consulting by submitting your resume. Please reference job code RA and your name in the subject line in the email (Example: RA – Smith, John).
Pacific-Link Consulting is an Equal Opportunity Employer.
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