PPD is a leading global contract research organization providing discovery, development and post-approval services as well as compound partnering programs. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 32 countries and more than 9,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help its clients and partners maximize returns on their R&D investments and accelerate the delivery of safe and effective therapeutics to patients.
Post: Regulatory Affairs Specialist (Mumbai / Gurgaon - India)-114262
Job 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
Candidate Profile:
* 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.
Additional Information:
Experience: Min. 2 Years
Location: Maharashtra-Mumbai
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
Job Code: 114262
End Date: 21st November, 2014
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