Regulatory Affairs Sr. ManagerAssociate Director
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Job Location:
Monthly Salary:
Posted on:
15 hours ago
Vacancies:
1 Vacancy
Job Summary
Essential Functions
May act as a Project Manager for a large stand-alone programme involving several regulatory or technical deliverables and/or region and/or operation; Undertakes risk analysis management and contingency plans as appropriate;
Provides strategic regulatory and/or technical consultancy on a variety of projects internally and externally using innovative solutions where appropriate;
May manage meetings with Regulatory Agencies;
May write and/or review a complete single service regulatory proposal and defend costs and timelines to clients;
Provides mentorship to junior colleagues and advise others on many regulatory document types;
May plan and deliver workshops or presentations on Regulatory Affairs topics for conferences or publications;
May be assigned as Reviewer and/or Approver for Regulatory standard operating porcedures or cross-functional standard operating porcedures owned by other operations;
May support global regulatory or technical initiatives or act as a regional representative on a cross-functional initiative;
Performs other tasks or assignments as delegated by Regulatory management;
Qualifications
Bachelors Degree Degree in Lifescience or related discipline
Masters Degree Degree in Lifescience or related discipline
At least 8 years relevant experience including 6 years regulatory experience or combination of education training and experience
Extensive experience in regulatory and/or technical writing
Advanced negotiating and influencing skills and the ability to identify and resolve issues using flexible adaptable approach. Remains calm assertive and diplomatic in challenging interactions with customers
Strong software and computer skills including MS Office applications
Acts as a role model to junior colleagues; possesses a positive attitude and communication style to customers and colleagues. Communicates effectively with all levels of the organization and remains motivated and enthusiastic in times of change and other pressure situations
Ability to exercise independent judgement taking calculated risks when making decisions
Applicable certifications and licenses as required by country state and/or other regulatory bodies
IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
Required Experience:
Director
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more
