Work schedule
standard (mon-fri)
environmental conditions
office
job description
join us as a senior regulatory affairs specialist – make an impact at the forefront of innovation
we have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you’ll have the opportunity to serve as a senior contact in providing innovative solutions, including regulatory expertise. As a senior regulatory affairs specialist, you'll interact with clients to provide strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization. You will provide strategic, expedient, and efficient preparation of client deliverables that meet current local, regional, and ich regulatory and technical requirements.
Additionally, you will act as a liaison with internal and external clients in the provision and marketing of these services.
What you’ll do
prepares and reviews regulatory submissions.
Provides regulatory strategy and/or technical advice to internal and external clients, and acts as a liaison in executing strategies.
Leads the development and implementation of project-specific processes for sponsors.
Collaborates extensively with other departments, regulatory consultants, and regulatory authorities.
Assists in identifying and recognizing out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications.
Provides training and guidance to junior team members as appropriate.
Participates in project launch meetings, review meetings and project team meetings.
Supports business development activities, including project budgeting/forecasting.
Education and experience requirements:
bac