This section is for individuals who have some experience in related fields (e.g. clinical, life sciences, public health or engineering) and are seeking to transition into a regulatory position and advance their career. At this level there is a strong emphasis on technical aspects of the profession, combined with scientific understanding and strong project management. Level II professionals often expand their involvement in international/multinational regulatory issues and begin more active involvement with concepts of regulatory strategy. They perform technical and scientific regulatory activities.
At this level, you should demonstrate knowledge and skills in areas such as, but not limited to, regulatory pathways and options; documentation; risk-benefit analysis; communication and collaboration internally and externally; working with vendors and subcontractors; submission, registration, obtaining approval, documentation, compliance, postmarketing surveillance/vigilance; and distribution. These individuals focus on hands-on training to strengthen and develop new skills and knowledge.
Regulatory Affairs Certification is targeted to professionals at this level. (Example job titles: some associate positions, specialist, and some assistant manager and manager positions)
In this section:
Overview by Typical Position Titles for the New Regulatory Profession (Level II)
Knowledge and Skills of the New Regulatory Professional (Level II)
Recommended Reading
Articles and books to help you succeed and advance at this level in your career.
Professional Development
Continue your learning and plan your professional development. A wide variety of education and training opportunities are available.
Additional Resources:
Job Search Resources
Job search resources available from RAPS.
Networking
RAPS offers unprecedented opportunities for networking.