Regulatory Affairs Associates
SOC 13-3099-99
Regulatory Affairs Associates handle the regulatory affairs for biotechnology, defense, bio-medical device manufacturing, and other companies. They are responsible for preparing company product for registration or license renewal submissions and filing them with various government regulatory bodies. They stay current with regulatory procedures and changes. They monitor and improve tracking and control systems and recommend strategies for gaining early approvals of the company's submissions.
Wages and Benefits
| Hourly Wages | Range | Median |
|---|---|---|
| New Hires, No Experience | $17.25 - $23.75 | $17.78 |
| New Hires, with Experience | $18.00 - $41.00 | $28.00 |
| After Three Years with the Firm | $19.25 - $52.75 | $31.98 |
Average Weekly Hours:
All (100%) Regulatory Affairs Associates work full time, 46 hours per week.
Shifts:
Almost all Regulatory Affairs Associates work regular day shifts.
Percent of Employers Offering Fringe Benefits:
| Full-Time Employees | ||
| Benefit Offered | % of Employers | |
| Medical Insurance: | Yes* | 100% |
| Dental Insurance: | Yes | 100% |
| Vision Insurance: | Yes | 94% |
| Life Insurance: | Yes | 94% |
| Disability: | Yes | 100% |
| Paid Sick Leave: | Yes | 94% |
| Paid Vacation: | Yes | 88% |
| Retirement Plan: | Yes | 94% |
| Child Care: | Yes | 18% |
*24% of employers cover 100% of medical insurance premiums;
76% of employers cover 50-99% of medical insurance premiums.
Other Employer Specified:
Flex Spending Accounts.
EMPLOYER REQUIREMENTS
Education:
Most (77%) firms require a bachelor's degree, few (17%) accept a graduate degree and few (6%) require an associate's degree
Training:
Few (18%) firms allow training to substitute for work experience. Some (29%) require technical or vocational training typically encompassing regulatory affairs or clinical research classes.
Experience:
Almost all (94%) firms prefer applicants with 5 years experience as a Regulatory Affairs Associate and proficiency in MS Office. Many (53%) accept prior experience in a related occupation, such as Clinical Research Assistant, Institutional Review Board Assistant, Pharmaceutical Technician, or Project Assistant.
Skills rated "Very Important":
Ability to be well organized
Ability to meet deadlines and work under pressure
Possession of great attention to detail
Ability to work independently
Ability to work as a member of a team
Good oral and written communication and negotiation skills
Possession of computer application skills
Knowledge of Institutional Review Board policies and procedures
Understanding of various regulatory bodies and how they function
Ability to plan and co-ordinate multiple projects simultaneously
Ability to be innovative, enthusiastic, and self-confident
Ability to critically analyze and present scientific data in a professional manner
EMPLOYMENT TRENDS
Supply and Demand:
Employers report it "Very Difficult" finding qualified, Experienced applicants, resulting in little-to-no competition for job seekers in their job search; and "Moderately Difficult" finding qualified, Inexperienced applicants, resulting in some competition for job seekers in their job search.
Recruitment Methods, Most Frequently Used:
Employee Referrals, Word of Mouth, Newspapers.
Turnover:
Moderate: 19% in the past 12 months.
Size of 2006 Local Employment:
Not available.
Gender Representation:
Local employer response indicates 67% female, 33% male.
Older Worker Retirement:
Many (47%) firms report that older worker retirements over the next 10 years will affect their workforce.
To address the effects of older worker retirements, employers of this occupation would: Do nothing, 59%; groom a replacement ahead of time, 41%; replace with any qualified applicant, 6%; encourage older workers to delay their retirement, 6%; initiate job sharing among older workers, 6%; retain an older worker as a consultant, 24%.
Few (6%) firms report that older workers would face employment obstacles in this occupation: none specified.
Where the Jobs Are:
Bio-Medical Device Manufacturers
Bio-Science Research Companies
Defense Contractors
Pharmaceutical Companies
Employers' Employment Outlook:
17 employers responded, providing data representing 46 employees for this occupation.
7 employers project employment to grow, 8 expect it to remain stable, and 2 expect it to decline over the next twelve months.
Annual Job Growth Projections for San Diego County:
| Average annual new jobs: | Not available |
| Average annual replacement jobs: | Not available |
| Average annual total openings: | Not available |
New Job Growth Rate 2002 to 2012:
Not available
OTHER INFORMATION
Career Ladder/Promotional Opportunities:
Promote from: Research Associate, Quality Analyst, and Senior Manager.
Promote to: Regulatory Affairs Scientist, Director Level 2 & 3, and Principal Consultant.
Ex-Offender Employment:
No responding employers would consider hiring an ex-offender.
Alternate Job Titles:
Principal Consultant, Regulatory Affairs Manager, and Regulatory Affairs Specialist.
Related Codes:
MOC - Not available.
Data Collection Date:
Fall 2005