I share my career insights and learnings. And I do it
Qualifications, experience, and skills needed for Regulatory Affairs Consultants
Wondering what qualifications and experience are needed for a
Regulatory Affairs Consultant?
A Regulatory Affairs Consultant is crucial in providing strategic guidance on regulatory requirements and submissions. They provide leadership in regulatory strategies and guidance for submissions during clinical drug development, act as the main client contact, and ensure cross-departmental collaboration between departments for complex large clinical development programs.
Learn more about our Regulatory Affairs department or learn more about a day in the life of a Regulatory Affairs Consultant.
Q: What are the educational requirements for a Regulatory Affairs Consultant?
A: A university degree is typically the minimum requirement. Common fields of study include:
- Life Sciences (Biology, Chemistry, etc.)
- Health Sciences
- Pharmacy
- Regulatory Affairs
Q: How much experience is needed to be a Regulatory Affairs Consultant?
A: Generally, Regulatory Affairs Consultants are expected to have 3-5 years of experience in regulatory affairs or related fields. The experience required includes:
- Understanding of the drug development process
- Strong knowledge of regulatory affairs and health authority requirements
- Knowledge of various pre and post approval regulatory applications and submissions
- Project Management experience
Q: What roles, or experience, do people have before becoming a Regulatory Affairs Consultant?
A: Before assuming the role of a Regulatory Affairs Consultant, individuals typically gain experience and expertise through various roles. Some common roles include:
- Regulatory Affairs Associate
- Regulatory Submissions Specialist
- Regulatory authoring and/or regulatory review
- Knowledge of the eCTD modules (i.e. quality related information (CMC), non-clinical toxicology, pharmacology, clinical), labeling, and/or compliance
Q: Are there any certifications required to be a Regulatory Affairs Consultant?
A: While not always required, certain certifications can be beneficial:
- Regulatory Affairs Certification (RAC)
- Good Clinical Practice (GCP) certification
- Project Management Professional (PMP)
Q: What are the competencies and technical skills needed to be a Regulatory Affairs Consultant?
A: To excel in regulatory affairs, individuals require a diverse set of competencies and technical skills:
- Knowledge of health authority requirements and clinical drug development processes
- Solid analysis and synthesis capability
- Solution-oriented and problem-solving skills
- Customer-oriented approach
- Regulatory submission expertise
- Project management skills
- Attention to detail and quality management
- Fluency in English and local language
Featured Jobs
- Senior Consultant: Advanced analytics: RWE Analytics - India - Remote
- Regulatory Affairs Consultant Safety/Labelling Poland - Remote; Belgrade,Serbia;Bucharest,Romania;Budapest,Hungary;Dublin,Ireland;Madrid,Spain;Milano,Italy;Prague,Czechia;Vilnius,Lithuania;Zagreb,Croatia, Remote
- Principal Regulatory Affairs Consultant - CMC small molecule United Kingdom - Remote; Belgrade,Serbia;Bucharest,Romania;Budapest,Hungary;Dublin,Ireland;Madrid,Spain;Milano,Italy;Prague,Czechia;Vilnius,Lithuania;Warsaw,Poland;Warszawa,Poland;Zagreb,Croatia, Remote
Explore Parexel
-
Learn MoreAbout our hiring process
It’s all about finding the right fit, for you and for us. Our recruiters work with you and our hiring managers to bring together a team and culture where everyone can grow and be successful.
-
Learn MoreRegulatory Affairs Jobs at Parexel
Help shape the future of drug development, streamline approval processes, and safeguard patient well-being. Advance your career and explore Parexel's diverse roles in Regulatory Strategy, Regulatory Affairs, Compliance, Consulting, and more.
-
Learn MoreMeet Zulma, Senior Regulatory Affairs Manager
Discover Zulma's inspiring career in regulatory affairs at Parexel. From mentoring talent to dancing across cultures, learn how she balances technical expertise with empathy in clinical research, always keeping patients at the heart of her work.
Sign up for our Talent Community
Sign up and we’ll reach out with job alerts when positions that match your career interests become available. We’ll also share periodic updates about the latest company news and events.