Senior Regulatory Officer
The Senior Regulatory Officer (RO) is a member of the Regulatory Team. The RO assists with and/or is responsible for writing regulatory submissions and routine regulatory reports for all registered products. The position involves managing regulatory files and verbal and written communications with numerous regulatory agencies.
- Successful completion of regulatory submission documents within the project timelines.
- Successful completion and on-time submission of regulatory reports.
- Effective document tracking for all regulatory documents.
- Approval of new submissions by regulators.
- Acceptance of regulatory reports by regulators.
- Translates science-based information into regulatory reports and documents.
- Completes quality documents for regulatory reports and submissions in a timely manner.
- Communicates within and between the company’s departments on regulatory matters, most often but not limited to Quality Assurance/Quality Control (QA/QC).
- Communicates with regulators as appropriate.
- Meticulous attention to detail
- Good organizational skills
- Good time management skills
- Takes pride in quality of work
- Takes initiative
- Good problem-solving skills
- Good team player
Personality and communication (soft skills):
- Positive attitude
- Engages well with co-workers and external contacts for the company
- Efficient, expedient, and innovative
- Strong communication skills – good listener and communicator
- Keen learner, who continually strives to improve skills and knowledge
- Strong scientific/regulatory process and submission skills
- Experienced project planning
- Familiarity with aquatic animal health
- Familiarity with basic pharmacology
- Bachelor’s or more advanced degree in regulatory sciences or other associated discipline.
- Practical experience in preparing, submitting, and attaining drug approvals.
- Experience with regulatory programs and third-party certification programs.
- Experience with regulatory programs in pharmaceutical, food safety or aquatic animal health.
- Experience in pharmaceutical industry, pharmacy, and/or chemical or pharmaceutical manufacturing.
- Working knowledge of the US and Canadian regulatory process and requirements for drug submissions and approvals.
- Familiarity with aquatic animal health aspects of aquaculture and aquatic ecosystems/conservation.
- Familiarity with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP) and/or Good Laboratory Practices (GLP).