Regulatory Affairs Specialist

Salary Range for Regulatory Affairs Specialist in Biological Product (except Diagnostic) Manufacturing

The salary range for a Regulatory Affairs Specialist in the Biological Product (except Diagnostic) Manufacturing industry typically varies based on factors such as experience, education, location, and company size. However, the average salary range for this position is around $70,000 to $100,000 per year.

Sample Job Description for Regulatory Affairs Specialist in Biological Product (except Diagnostic) Manufacturing Industry

Job Description:

A Regulatory Affairs Specialist In The Biological Product (Except Diagnostic) Manufacturing Industry Plays A Crucial Role In Ensuring Compliance With Regulatory Requirements And Guidelines. Their Primary Objective Is To Facilitate The Smooth And Timely Approval Of Biological Products, While Also Ensuring Ongoing Compliance With Regulations.

Job Objective:

As A Regulatory Affairs Specialist, Your Objective Is To Oversee And Manage The Regulatory Affairs Activities Related To The Development, Registration, And Post-Approval Support Of Biological Products. You Will Collaborate With Cross-Functional Teams To Ensure Compliance With Applicable Regulations, Guidelines, And Standards Set By Regulatory Authorities. Your Role Is Pivotal In Ensuring The Successful Commercialization Of Safe And Effective Biological Products.

Job Requirements:

1. Bachelor'S Degree In A Scientific Discipline (E.G., Biology, Chemistry, Pharmacy, Or Related Field). 2. Strong Knowledge Of Regulatory Requirements And Guidelines, Particularly Related To Biological Products. 3. Experience Working In The Pharmaceutical Or Biotechnology Industry, Preferably In A Regulatory Affairs Or Related Role. 4. Familiarity With The Regulatory Landscape And Submission Processes For Biological Products. 5. Excellent Written And Verbal Communication Skills, Including The Ability To Prepare And Review Regulatory Documents. 6. Detail-Oriented And Capable Of Managing Multiple Projects Simultaneously. 7. Strong Analytical And Problem-Solving Skills. 8. Ability To Work Effectively In A Cross-Functional Team Environment. 9. Proficient In Using Regulatory Databases And Software Applications. 10. Knowledge Of Good Manufacturing Practices (Gmp) And Quality Systems Regulations (Qsr).

Job Responsibilities:

1. Develop And Implement Regulatory Strategies For The Approval And Post-Approval Support Of Biological Products. 2. Prepare And Review Regulatory Submissions, Including Investigational New Drug (Ind) Applications, Biologics License Applications (Bla), And Variations. 3. Liaise With Regulatory Authorities To Address Inquiries And Provide Necessary Documentation. 4. Ensure Compliance With Applicable Regulations And Guidelines Throughout The Product Lifecycle. 5. Collaborate With Cross-Functional Teams To Provide Regulatory Guidance And Support During Product Development And Registration. 6. Stay Updated With Changes In Regulatory Requirements And Assess Their Impact On Product Development And Registration Activities. 7. Participate In Regulatory Agency Meetings And Provide Expertise On Regulatory Matters. 8. Conduct Regulatory Assessments Of Proposed Changes To Products Or Processes. 9. Support The Preparation And Review Of Labeling, Promotional Materials, And Product Documentation. 10. Assist In The Development And Implementation Of Regulatory Training Programs For Internal Stakeholders.

Top 10 Employers for Regulatory Affairs Specialist in Biological Product (except Diagnostic) Manufacturing:

1. Company XYZ - HQ Location: City, Country - Website: www.xyzcompany.com 2. Company ABC - HQ Location: City, Country - Website: www.abccompany.com 3. Company DEF - HQ Location: City, Country - Website: www.defcompany.com 4. Company GHI - HQ Location: City, Country - Website: www.ghicompany.com 5. Company JKL - HQ Location: City, Country - Website: www.jklcompany.com 6. Company MNO - HQ Location: City, Country - Website: www.mnocompany.com 7. Company PQR - HQ Location: City, Country - Website: www.pqrcompany.com 8. Company STU - HQ Location: City, Country - Website: www.stucompany.com 9. Company VWX - HQ Location: City, Country - Website: www.vwxcompany.com 10. Company YZA - HQ Location: City, Country - Website: www.yzacompany.com

Career Path for Regulatory Affairs Specialist in Biological Product (except Diagnostic) Manufacturing:

To attain the position of a Regulatory Affairs Specialist in the Biological Product (except Diagnostic) Manufacturing industry, the following career path is recommended: 1. Entry-level Regulatory Affairs Associate: Bachelor's degree in a scientific discipline, 0-2 years of experience. 2. Regulatory Affairs Coordinator: Bachelor's degree in a scientific discipline, 2-4 years of experience. 3. Regulatory Affairs Specialist: Bachelor's degree in a scientific discipline, 4-6 years of experience. 4. Senior Regulatory Affairs Specialist: Bachelor's degree in a scientific discipline, 6-8 years of experience. 5. Regulatory Affairs Manager: Bachelor's degree in a scientific discipline, 8-10 years of experience, demonstrated leadership abilities. 6. Director of Regulatory Affairs: Bachelor's or Master's degree in a scientific discipline, 10+ years of experience, management experience. 7. Vice President of Regulatory Affairs: Bachelor's or Master's degree in a scientific discipline, 15+ years of experience, demonstrated strategic leadership. The recommended number of years in each position may vary based on individual circumstances and professional growth.

Top 5 Countries by Regulatory Affairs Specialist in Biological Product (except Diagnostic) Manufacturing:

1. United States 2. Germany 3. United Kingdom 4. France 5. Switzerland

Top 5 Countries with Established Biological Product (except Diagnostic) Manufacturing:

1. United States 2. Germany 3. Switzerland 4. Ireland 5. Japan