Regulatory Relations Specialist jobs in Chula Vista, CA

Overview: We are seeking a highly motivated and detail-oriented Regulatory Specialist to join our team. As a Regulatory Specialist, you will play a crucial role in ensuring compliance with FDA regulations and maintaining quality assurance in our organization. This is an exciting opportunity for someone with a strong background in chemistry manufacturing controls, clinical trials, and compliance management. Duties: - Conduct research on FDA regulations and industry best practices to ensure compliance - Develop and implement strategies to maintain regulatory compliance throughout the organization - Collaborate with cross-functional teams to ensure that products meet regulatory requirements - Prepare and submit regulatory documents, such as INDs, NDAs, and annual reports - Assist in the coordination of clinical trials, including protocol development and study documentation - Monitor changes in regulations and communicate updates to relevant stakeholders - Support quality assurance activities, including internal audits and inspections - Provide guidance on regulatory matters to internal teams and external partners - Participate in project management activities related to regulatory submissions Qualifications: - Bachelor's degree in a scientific field, preferably in chemistry or related discipline - Strong knowledge of FDA regulations and guidelines related to pharmaceuticals or medical devices - Experience working with chemistry manufacturing controls (CMC) and clinical trial applications (CTA) - Proven track record of successfully managing regulatory projects and ensuring compliance - Excellent research skills with the ability to analyze complex information - Detail-oriented mindset with strong organizational skills - Effective communication skills, both written and verbal - Ability to work independently as well as collaboratively in a team environment We offer competitive compensation packages and opportunities for professional growth. If you are passionate about regulatory affairs and have a strong understanding of FDA regulations, we encourage you to apply for this position. Note: All positions at our company are paid, including internship positions.

Job Type: Full-time

Pay: $28.00 - $31.00 per hour

Expected hours: 40 per week

Benefits:

• Health insurance
• Paid time off

Experience level:

• 2 years

Schedule:

• 8 hour shift

Ability to Relocate:

• San Diego, CA 92114: Relocate before starting work (Required)

Work Location: In person