Senior Regulatory Affairs Specialist (Europe/Virtual)
Multiple Locations: Bucharest, Bucureşti, Romania • Rome, Latium, Italy • Warsaw, Mazovia, Poland • Vojvodina, Serbia • Sofia, Bulgaria • Zagreb, City of Zagreb, Croatia • Prague, Praha, Czechia
Requisition Number: 785
Position Title: Specialist, Regulatory Affairs
SUMMARY: The Senior Specialist, Regulatory Affairs provides project representation and input to projects awarded to WCT for all stages of the drug development cycle.
- Liaise with the Regulatory Affairs Manager/Regulatory Affairs Director to plan, organise, compile progress and submit regulatory submissions on a timely basis
- Coordinate & manage regulatory & ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions
- Provide advice on appropriate regulatory strategies
- Stay abreast of changing regulatory legislative requirements and maintain regulatory intelligence database
- Contribute towards the preparation of technical reports, which may involve chemical, pharmaceutical, toxicological, pharmacological and clinical aspects of specified regulatory submissions.
- Review and make recommendations on all relevant documentation e.g. labels, patient information sheets, diary cards etc…to ensure compliance with ICH GCP & country specific requirements
- Effectively communicate status of submissions with the Sponsor, Head of Regulatory Affairs, Project Manager, CRAs, Medical & Scientific Affairs staff.
- Comply with SOPs, ICH GCP and national regulations as applicable
- Foster professional working relationships with internal and external contacts at the local and international levels to ensure expeditious submission/approval of regulatory dossiers
- Deputize for the Regulatory Affairs Manager/Director as required
OTHER SKILLS AND ABILITIES:
- Clearly, proven organizational management skills are essential attributes
- Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills
- Excellent written and verbal communication skills to clearly and concisely present information
- Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
- Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment
- Ability to exercise sound judgment and make decisions independently
- Excellent self-motivation skills
- Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint
- Good knowledge of ICH GCP
- Good knowledge of EU Clinical Trials Directive
- Bachelor's Degree in Chemistry or Life Sciences, Nursing or equivalent experience
- Previous experience within the pharmaceutical/CRO industry
Employment Type: Regular
Community / Marketing Title: Senior Regulatory Affairs Specialist (Europe/Virtual)
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: Belgrade, RS