- Regularly search the public domain for new and updated regulations and regulatory guidance documents that can impact the client's development programs, and report the most critical findings.
- Regularly search the public domain for competitor product regulatory developments and report the most critical findings.
- Inform client immediately of any changes to the regulatory environment directly affecting client's business.
- Search for non-compliance letters or notices for client's suppliers and provide a regular report.
- Perform ad hoc research on specific regulatory topics at client's request, using the internet and various subscription database tools.
- Identify public commenting opportunities for draft guidances/regulations and coordinate review and comments from client. Lead the client's internal process to obtain and coordinate SME impact assessments/comments, facilitate comment collection/assimilation, and help develop company messaging to share either with PhRMA working groups or directly with Health Authorities.
- Maintain a list of upcoming regulatory meetings/workshops/conferences pertinent to client.
- Support Regulatory Intelligence activities, including the use of Cortellis, Citeline, WebWatcher. This includes tracking, coordinating and participating in ad hoc searches as well as scheduled activities. To ensure success in this role, you will have:
- At least 5-7 years of regulatory affairs experience, with some experience doing regulatory intelligence research for a Sr. Consultant level role.
- Knowledge of FDA regulations as well as an understanding of the Summary basis of approval and labeling is helpful.
- A minimum of a bachelor's degree in a scientific or technical discipline, advanced degree preferred.
- Project management / leadership experience
- Excellent interpersonal and intercultural communication skills, both written and verbal
- Client-focused approach to work (Quality)
- Results orientation
- Teamwork and collaboration skills
- Consulting skills
- Critical thinking and problem-solving skills
- Proficiency in local language and extensive working knowledge of the English language #LI-REMOTE
Senior Regulatory Affairs Consultant - Northeast, United States - Parexel
Description
Do you have a passion for Regulatory Affairs and Product Development? Incredible attention to detail? Superior research and information gathering experience? Excellent communication skills? An interest in CNS and Oncology therapies? If so, we have an incredible opportunity to join our team as a Regulatory Intelligence Senior Regulatory Affairs Consultant and join a large, dedicated sponsor partnership.
As a Regulatory Intelligence Sr. Consultant, you will: