Regulatory Affairs as a profession evolved due to governmental concern to safeguard public health. How? by controlling the safety/efficacy of products discovered, developed manufactured and marketed in areas including pharmaceuticals, medical devices, veterinary medicines, pesticides, agrochemicals, cosmetics, and consumer goods. The desired result being that products are safe and make a worthwhile contribution to public health and welfare. A new class of professionals emerged to handle these regulatory matters – LDI work globally across the regulatory discipline, partnering with companies to ensure the right talent is in place to fulfil these critical roles.
The focus of regulatory professionals will vary depending organisational structure. One common structure is broken down by assigned geographical responsibility varying from a local affiliation role based in a specific location (or country), to regional/global leading roles based in a regional or global centre. Each role will have different day to day activities/responsibilities and require varying experience levels.
LOCAL
- Responsible for regulatory activities in a country
- Local Employees or Third parties (CRO)
- Usually focused on post approval activities
- Maintain relationships with local health authorities
- In-depth local regulatory knowledge
- Interpret global regulatory strategy and communicate
- Work with local teams/functions (Commerical/Market access/ Medical affairs)
REGIONAL
- Responsible for managing the regulatory activities of a region (i.e EU, Asia Pac, LATAM, EMEA, Americas)
- Can sit in a Regional or parent Head Office or even local office. Can cover Pre and Post market activity
- Responsible for regional relationships with health authorities
- Regional regulatory requirement experts
- Contribute to global regulatory strategy
- Responsible for relationships with the commercial teams in region
GLOBAL
- Normally sit within the Global Head Office or Parent organisation
- Cover Pre and Post market activity. Take a global lead with Health Authorities
- Responsible for internal governance
- Usually part for the core Global projects teams working with commercial, market access and clinical.
- Responsible for communicating Global Regulatory strategy
- Support regional Regulatory teams
- Liase with regional leads
Regulatory Affairs Life Cycle
Pre Market
- Pre-market is generally focused on pre-approval work of getting new products to market and often based in regional/global sites where R&D facilities are most often based.
- Support License applications with data packages
- Advising on requirements for clinical trials
- Submission of relevant applications
- Working closely with all relevant global colleagues
Post Market
- Post market work focuses on maintaining the compliance of the authorised licence to ensure the product can remain in market.
- Supports the development of product in market, variations n labelling, design changes, field actions, renewal license, safety reports etc
- Submitting amendments
RA Career Levels
1. CQO / SVP / Head of Regulatory Affairs
Description:
Head of Function, Fully accountable for the Regulatory Affairs Function
2. VP / Global Director / Director / Associate Director
Description:
Leading a Division / Geography / Project / Vertical / Senior Leadership
3. Senior Manager / Manager / Consultant
Description:
Regional / Project / Product / Leadership role. Line Management
4. Junior Manager / Principle RA / Senior RA Associate / RA Associate / RA Officer
Description:
Individual contributor role. Some project/product responsibility. Support to leadership.
5. RA Assistant / Publisher / Writer / QA Assistant / Administration
Description:
Leading a Division / Geography / Project / Vertical / Senior Leadership
