Regulatory Associate

2 months ago

Newtown, United States KVK Tech Full time
Job DescriptionJob Description

Department: Regulatory Affairs

Job Title: Regulatory Associate

 

1. Role Purpose:

Primary responsibility is writing 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:

  • Interacts effectively with cross functional teams to coordinate/facilitate procurement of documentation required for regulatory submissions, ensuring that departmental timelines are met.
  • Create documents in accordance with eCTD specifications.
  • Prepare and submit regulatory submissions using eCTD software, publishing tool to FDA.
  • Author, compile and review technical documents (CMC) for accuracy and acceptability in New Applications (i.e. ANDAs or NDAs], Amendments, Supplements, PADER, Annual Reports and other required FDA filings to ensure high-quality submissions and expeditious approvals from FDA.
  • Coordinate preparation of SPL for drug products and update labelling, annual drug listing.
  • Reviews and signs-off on change control documentation. Assesses changes and their impact on the business based on an understanding of product, regulatory guidelines and applicable federal laws.
  • Update and maintain the internal database as needed.
  • Comply with FDA guidelines/Company Policies of Data Integrity.
  • Effectively prioritizes competing tasks in a fast-paced and dynamic environment.
  • Other duties as required or delegated

 

3. Typical Supervisory Responsibility:

N/A

 

4. Education & Experience:

Education Requirement

Specialization (If any)

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

 

Experience Requirement

N/A

Number of Years

N/A

 

5. Technical competencies/ Certifications/ Licenses:

Technical competencies

  • At least 1 year experience with technical writing preferred
  • Minimum 3 years Pharma experience preferred
  • Proficient with Adobe PDF, Illustrator/In Design, Microsoft Office and advanced computer skills
  • Continuous working knowledge of applicable FDA/ICH/DEA regulations
  • Continuous working knowledge of applicable cGMP guidelines

Certifications

N/A

Licenses

N/A

Other

N/A

 

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

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