Regulatory Affairs Assistant

The Regulatory Affairs Assistant shall be familiar with the requirements of the job description, the McGuff organizational chart, and McGuff policies and procedure related to Regulatory Affairs and Operations.

Job Description:

The Regulatory Affairs Assistant will be responsible for ensuring the Regulatory Affairs activities to which they are assigned are completed in a comprehensive and timely manner to meet all applicable requirements.

In addition, and as appropriate, assist in Regulatory Affairs activities for McGuff Company, Inc., McGuff Outsourcing Solutions, McGuff Pharmaceuticals Inc., McGuff Medical Canada Inc., and McGuff Pharmaceutical Europe GmbH along with other RA functions within the company.

Overall responsibilities will include assisting the Regulatory Affairs department to ensure that McGuff operations remain compliant with all local, state, federal, and international regulations, and licensing requirements.

The Regulatory Affairs Assistant will work closely with other department colleagues and company management to ensure that all applicable policies and procedures, state and federal laws, and regulations are met.

Duties shall include:

1. Answer incoming phone calls and greet visitors at the main facility reception desk.

2. Assist and support Regulatory Affairs activities, e.g., support of the product development process, submissions, and regulatory compliance.

3. Assist in the assembly and compilation of content for regulatory submissions (e.g., NDA, ANDA, foreign registrations, licensing, etc.) intended for domestic and international regulatory bodies.

4. Assist in maintaining site registrations and licenses.

5. Assist in the development, revision, and implementation of safety training.

6. Assist in the review of product labeling and advertising materials for compliance with global submissions and applicable regulations; analyze and recommend appropriate changes as necessary.

7. Assist in the development, revision, and implementation of departmental procedures affecting regulatory affairs and compliance.

8. Assist in creating and maintaining departmental filing systems, both hard copy and electronic.

9. Participate in corrective and preventative actions as necessary.

10. Other duties as assigned.

Physical Requirements:

The position requires bending, squatting, climbing, and reaching above shoulder level. In addition, the job will require sitting, standing, walking, handling, and manipulating objects (manual dexterity and fine finger movement). The position may require lifting or carrying up to 50 pounds in an office setting.

Qualifications include:

11. Education: bachelor’s degree in a related field, preferably in a scientific or technical discipline, or comparable additional experience.

12. Relevant industry experience with regulatory affairs, quality assurance, or quality control of pharmaceuticals or related or similar industries or roles.

13. Familiarity with the FDA and international regulations

14. Familiarity with FDA cGMP requirements

15. Familiarity with NDA and ANDA product development and approval of drugs

16. Computer literate and familiar with computerized documentation and database methods, tracking, and control systems.

17. Ability to manage multiple projects.

18. Effective research and analytical skills.

19. Excellent written and oral communication, technical writing, and editing skills.

20. The preferred candidate will have direct experience with the successful filing of domestic and/or international marketing applications for injectable pharmaceuticals.

21. Working knowledge of FDA Ectd Module structure, XML, HTML and FDA submission coding or the willingness to be trained.

Expectations:

1. Comply with all McGuff policies and procedures.

2. Well organized and detail oriented.

3. Appropriate professional demeanor.

4. Knowledge, understanding, and compliance of the dress code.

5. Ability to work with others.

6. Work with all McGuff employees to foster and promote Regulatory Compliance in all assignments.

Job Type: Full-time

Pay: $25.00 - $35.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: In person

Salary : $25 - $35