Senior Specialist, Global Regulatory Affairs (EU)
SUMMARY: The Senior Specialist, Global Regulatory Affairs provides project representation and input to projects awarded to WCT for all stages of the drug development cycle.
Tasks may include but are not limited to:
- Liaise with the Regulatory Affairs Manager/Regulatory Affairs Director to plan, organise, compile progress and submit regulatory submissions on a timely basis
- Coordinate, track & 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
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
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
Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.