Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist

Department: Regulatory Affairs

Reports To: VP of Quality / Regulatory Affairs

PRIMARY PURPOSE or JOB SUMMARY

The Regulatory Affairs Specialist is responsible for developing, implementing and enforcing programs, policies and procedures to maintain compliance. The Regulatory Affairs Specialist shall fully comply with all regulatory I cGMP guidelines and Legacy Pharmaceutical Packaging standards and policies.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

1. Promote and enforce GMP and SOP compliance in a FDA regulated pharmaceutical manufacturing environment, ensuring product integrity, safety and compliance with standards.
2. Possess a working knowledge of cGMPs, FDA and DEA regulations and Legacy Pharmaceutical Packaging policies and procedures.
3. Timely Reviews and Submissions of regulatory applications, notices, filings to include but not limited to the following:
4. Annual Product Reviews (APRs)

• Product Drug Listings
• FDA Registration/ GDUFA
• State Registrations / DEA/ BNDD
• Field Alerts/ Recalls
• Customer/ Bulk Supplier Authentication
• ARCOS Reporting
• Quota Applications

1. Regulatory Audits / DEA
2. Maintain archives of regulatory documentation as specified in applicable procedures.
3. Perform and document investigations and implement corrective action and revise SOPs as needed.
4. Create Prescription Drug Pedigrees
5. Perform other duties and provide supplemental departmental support as required.

ACCOUNTABILITY

The Regulatory Affairs Specialist shall be held accountable for the compliance, accuracy and timeliness of responsibilities and work assigned.

SUPERVISORY RESPONSIBILITIES

None

QUALIFICATIONS

• • Bachelor's degree preferred or 5 years equivalent experience in a Quality Assurance / Regulatory Affairs role within the Pharmaceutical Industry.
  • Strong written and verbal communication skills
  • Strong leadership skills.
  • Familiarity with Microsoft Office (Word, Excel, PowerPoint).
  • Excellent technical writing skills.
  • Excellent problem solving skills with strong attention to detail.
  • Highly organized, with the ability to manage priorities and coordinate multiple projects simultaneously.

WORKING CONDITIONS

Office environment.

ADDITIONAL COMMENTS

Experience in a cGMP regulated environment required