Our client is looking for an outstanding Regulatory Affairs Director to join their leadership team and lead all regulatory affairs management aspects of their organization. This is a unique opportunity to provide critical strategic and day-to-day management support in the area of regulatory affairs management. Your specific areas of responsibility will include:
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) Prepare and submit submissions and ensure compliance with all regulatory requirements pertaining to product approval
4) Manage the process from development of regulatory strategies through to approval
5) Establish appropriate risk analysis activities which include the use of risk analysis tools
6) Provide update on regulatory requirement changes, which affect individual product specification or quality systems
7) Ensure that all regulatory-related policies and procedures are current in accordance with applicable regulations and standards
8) Provide regulatory guidance and support to project teams, including regulatory filing strategies, testing and standards requirements
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 biopharmaceutical industry is strongly preferred
4) Preference will be given to people have recent experience in regulatory affairs management
If you are looking to work with a well-established company - one of the top names in the industry - you should not let this opportunity pass by. However, for this Regulatory Affairs Director role, you must be someone who is experienced and passionate about regulatory affairs management.
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.