Regulatory Affairs Specialist post vacant @ PPD B9

Job Description:

• 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)
• 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
• Qualification: B.Sc Life Science / Biostatistics
• Experience : 1-2 years

Desired Skills

• 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;

Location: Mumbai

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