Our client is seeking a passionate and dedicated individual with a minimum of 2 years of experience in a similar Director of Regulatory Affairs & Quality Assurance role.
1) Contribute to the development and implementation of procedures and policies for regulation of marketed promotional materials
2) Develop strategies for regulatory approval and introduction of new products to market
3) Manage the process from development of regulatory strategies through to approval
4) Prepare and submit submissions and ensure compliance with all regulatory requirements pertaining to product approval
5) Ensure that all regulatory-related policies and procedures are current in accordance with applicable regulations and standards
6) Provide regulatory guidance and support to project teams, including regulatory filing strategies, testing and standards requirements
7) Establish appropriate risk analysis activities which include the use of risk analysis tools
8) Provide update on regulatory requirement changes, which affect individual product specification or quality systems
9) Establish solutions to regulatory problems utilizing novel approaches when required
10) Foster collaborative, efficient and effective working relations with regulatory authorities such as FDA
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1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the pharmaceutical industry is strongly preferred
4) Preference will be given to people who have recent experience in RA & QA management
If you find yourself to be a perfect match for this role, you could be just the person to fill the position. Please apply ASAP.
Sterling-Hoffman Life Sciences is the premier recruitment firm in North America for companies involved in the research, clinical development, manufacturing and distribution of drugs and devices that allow patients to live healthier and more fulfilling lives. Leveraging a network of relationships in every major city – including New York, San Francisco, Raleigh-Durham, Chicago, Dallas, Denver and Los Angeles – Sterling-Hoffman Life Sciences is ideally positioned to assist fast growing CROs, pharmaceutical companies, biotech firms and medical device players in their quest to recruit the best people.