PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, employing a global team of skilled professional and experts that span across strategically located offices in the United States, Europe, Asia, and the Middle East. PSC operates in 52 countries globally and has served thousands of clients to date.
We focus on providing quality consulting services to ensure our client’s success. PSC provides cost-effective solutions, while providing exceptional technical capabilities and customer service to our clients for all projects ranging from supplier quality audits to greenfield projects. We understand that the world of life science is evolving rapidly, and we must continue to offer new products and services to meet our customer’s expectations.
We are looking for a Regulatory Specialist to join our team.
- Explaining regulations, policies, or procedures.
- Ensuring adequate compliance with regulations.
- Advising others on matters that are related to regulatory processes and compliance.
- Providing correct and accurate technical review of data or reports.
- Overseeing the planning, coordination, and management of regulatory documentation activities.
- Examining, identifying, and interpreting relevant regulatory guidelines.
- Analyzing and evaluating laws and regulations that apply to the process of determining the impact on company activities.
- Developing and maintaining healthy communication with regulatory agencies regarding pre-submission strategies, compliance test requirements, potential regulatory pathways, or clarification, and follow-up on submissions still under review.
- Bachelor’s Degree from a 4-year university.
- Minimum of 3 years of experience in a Regulatory Function at a pharmaceutical company.
- Must have Regulatory Affairs knowledge.
- Ability to organize and submit new drug or generic drug applications into various countries regulatory bodies
- Knowledge of ICH, FDA, MHRA, EU, JP, etc.. regulations
- Ability to organize and submit medical device (510k) applications into multiple countries
- Strong Analytical Skills.
- Strong communication skills, both verbal and written.
- Must understand data.
- Must be highly motivated.
- Must be detail-orientated and collaborate well with others across the organization.