The Regulatory Affairs Manager (RAM) plans, prepares and delivers Clinical Trial Application (CTA) related regulatory documents to Health Authorities and/or Marketing Companies. The CTA RAM position sits within Regulatory Affairs Management Team. The team is accountable for end to end delivery of regulatory submissions in line with business priorities by providing regulatory expertise, efficient project management, and strong leadership within the CVRM area.
Responsibilities include but are not limited to:
- Planning, preparing, handling, distributing and submitting regulatory documents to Health Authorities and/or Marketing Companies, globally, in support of clinical trials.
- Providing regulatory expertise on clinical trial related submissions to cross functional teams
- Monitoring, interpreting and validating current and changing regulatory legislation in relation to clinical trials and sharing potential impact these activities may have on the product development program.
- Performing regulatory review of clinical trial related documents
- Document management including updating and tracking study specific regulatory files and systems according to established AZ procedures and regulatory requirements
- Ensuring that all work is performed in accordance with established procedures and regulatory requirements
- Contribute to improvement of internal processes
Education, Qualifications, Skills and Experience
- University Degree in Science or related field
- Relevant regulatory experience or experience elsewhere in Pharmaceutical Industry e.g. CRO, Marketing Company, Health Authority, R&D or Operations
- Excellent written and verbal communication skills
- Proficient verbal and written English
- Project Management experience
- Demonstrated good organization and time management skills and ability to manage tight timelines when required
- Ability to work in teams and collaborate closely with other functions
- Proficiency in various computer applications and the ability to quickly gain knowledge of, and operate in, internal databases
- Knowledge of new and developing regulatory and pharmacovigilance expectations
