Description
Responsibilities:
- Plan, prepare and review regulatory submissions for a wide range of products globally
- Provide regulatory strategy advice to current and future clients
- Maintain knowledge of and understand PPD SOPs, Client SOPs/directives and current regulatory guidelines
- Assist with project budgeting/forecasting
- Assist in identifying and recognizing out of scope activities in a contract in a timely manner
- Other duties as required
*LI-KC1
Qualifications
- At least 2 years of professional experience within Regulatory
- Bachelor or higher graduate degree in science-related field
- Very good English language skills
- Attention to detail and quality of documentation
- Effective oral and written communication skills
- Ability to work on own with minimal supervision
- Good knowledge of global / regional / national country requirements / Regulatory Affairs Procedures with proven experience in at least one of the following areas;
- Authoring Chemistry Manufacturing & Control documents for post-approval regulatory submissions, including for European Union and other countries.
- Development of product information for post-approval regulatory submissions
- Working within Regulatory Information Management systems and submission publishing for electronic submissions to regulatory agencies
- Regulatory submission experience in marketing authorisation applications especially for Emerging Markets (Asia-Pacific, Latin America, Middle East, Africa, E Europe)
- Basic knowledge in one of the specialist areas; preclinical, clinical, or CMC, etc.
- Ability to act as liaison with other departments where necessary (i.e. Project Management, Clinical Supplies, QA, Clinical Management, Data Management, Biostatistics, etc)
- Suitable experience working in the pharmaceutical/CRO industry is preferred
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