Apply Online for Regulatory Affairs Manager at Worldwide Clinical Trials

Worldwide believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.

Post : Regulatory Affairs Manager

Job Description
SUMMARY
The Manager, Regulatory Affairs provides project representation and input to projects awarded to WCT for all stages of the drug development cycle and ensures the smooth running of the Regulatory Affairs Department

RESPONSIBILITIES :
• Provide expert regulatory advice and contribute to regulatory project work
• Ensure accurate compilation, management and tracking of submissions
• Participate in business development activities preparing regulatory sections of proposals and feasibility reports, regulatory costing and budgets and attend bid defense meetings to meet business needs
• Develop department work practices and other company initiatives
• Liaise with the 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

• Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database
• Contribute towards the preparation of technical documentation such as IMPDs and IBs 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, 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
• Provide training, coaching and mentoring to junior members of staff, may be required to line manage junior members of staff
• Deputised for the Regulatory Affairs Director as required

Candidate Profile
Bachelor's Degree in Chemistry or Life Sciences, Nursing or equivalent experience
Previous experience within the pharmaceutical/CRO industry

Candidate Profile
• Clearly, proven leadership and 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
• Expert knowledge of ICH GCP and the EU Clinical Trials Directive/National regulations (CTAs, Amendments, Urgent Safety Measures, End of Trial Notifications)
• Expert knowledge of drug development

Additional Information
Qualification : Degree in Chemistry or Life Sciences
Location : Virtual India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : DRA
End Date : 30th September 2026