Regulatory Affairs Specialist/Manager

Job Summary:
The Regulatory Affairs Specialist in a certified pharmaceutical laboratory is responsible for ensuring compliance with all regulatory requirements set by local, national, and international health authorities. This role involves preparing, submitting, and managing regulatory documents, maintaining communication with regulatory agencies, and ensuring that the lab’s products and processes meet all legal and quality standards. The ideal candidate will have a strong understanding of pharmaceutical regulations, excellent attention to detail, and the ability to work in a fast-paced, highly regulated environment.

Key Responsibilities:

• Regulatory Compliance:
• Ensure compliance with regulations set by agencies such as the FDA, EMA, WHO, and other relevant authorities.
• Stay updated on changes in regulatory requirements and communicate these changes to relevant departments.
• Document Preparation and Submission:
• Prepare, review, and submit regulatory documents, including INDs, NDAs, ANDAs, DMFs, and other filings.
• Ensure all documentation is accurate, complete, and submitted within deadlines.
• Product Registration:
• Manage the registration of pharmaceutical products in domestic and international markets.
• Coordinate with cross-functional teams to gather necessary data for product registration.
• Quality Assurance Collaboration:
• Work closely with the Quality Assurance (QA) team to ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other quality standards.
• Support audits and inspections by regulatory agencies.
• Labeling and Packaging Compliance:
• Review and approve product labeling and packaging to ensure compliance with regulatory requirements.
• Regulatory Strategy:
• Develop and implement regulatory strategies for new and existing products.
• Provide regulatory guidance to R&D, manufacturing, and marketing teams.
• Communication with Regulatory Agencies:
• Act as the primary point of contact for regulatory agencies.
• Respond to queries and requests for additional information from regulatory bodies.
• Training and Development:
• Train staff on regulatory requirements and updates.
• Ensure all employees are aware of compliance obligations.

Qualifications:

• Education:
• Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related field. Advanced degree (e.g., Master’s or PhD) is a plus.
• Experience:
• Minimum of 3-5 years of experience in regulatory affairs within the pharmaceutical industry.
• Experience working in a certified pharmaceutical lab or GMP environment is preferred.
• Certifications:
• Certification in Regulatory Affairs (e.g., RAC) is a plus.
• Skills:
• Strong knowledge of FDA, EMA, ICH, and other regulatory guidelines.
• Excellent written and verbal communication skills.
• Proficiency in regulatory submission software and tools.
• Strong analytical and problem-solving skills.
• Ability to manage multiple projects and meet deadlines.

Job Type: Full-time

Pay: $80,000.00 - $120,000.00 per year

Benefits:

• 401(k)
• Health insurance
• Paid time off

Schedule:

• 8 hour shift

Ability to Commute:

• Hauppauge, NY 11788 (Required)

Ability to Relocate:

• Hauppauge, NY 11788: Relocate before starting work (Required)

Work Location: In person

Salary : $80,000 - $120,000