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Regulatory Group Leader

5 months ago

Newtown, United States KVK Tech Full time
Job DescriptionJob Description

Department

Regulatory Affairs

Job Title

Group Leader

FLSA Status

Exempt

Reports To

Direct of Regulatory Affairs

 

1. Role Purpose:

Primary responsibilities are to manage, prepare and submit regulatory submissions by successfully coordinating with the Manager for priorities; while maintaining compliance with cGMP requirements, FDA, OSHA, EPA, and DEA.

 

2. Key Duties & Responsibilities:

  • Trains Regulatory Associates
  • Collaborates with R&D, QC and Production Managers
  • Handles all aspects of regulatory submissions (i.e. ANDA and NDA)
  • Assists associates, coordinators, analysts, auditors and specialists as needed
  • Handles and completes special projects as required
  • Comply with FDA guidelines/Company Policies of Data Integrity
  • Other duties as required or delegated

 

3. Typical Supervisory Responsibility:

Serves as an effective member of the Regulatory Affairs team and may serve as a mentor to other regulatory employees in the area of expertise.

 

4. Education & Experience:

Education Requirement

Specialization (If any)

Bachelor’s Degree in Pharmacy, Chemistry or Scientific Discipline preferred

 

Experience Requirement

5. Technical competencies/ Certifications/ Licenses:

Technical competencies

  • At least 2 - 3 years’ experience with technical writing preferred
  • Minimum 5 years Pharma experience preferred
  • Strong communication and problem-solving skills
  • Proficient with Adobe PDF, Microsoft Office, XML, eCTD tools and advanced computer skills
  • Continuous working knowledge of applicable FDA/ICH/DEA regulations
  • Continuous working knowledge of applicable cGMP guidelines

 

6. Physical demand and Work environment:

a. Physical demands:

While performing the duties of this job, the employee is required to walk, sit, and use hands to finger, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception.

b. Work environment:

N/A