Our client is currently recruiting a Director of Regulatory Affairs to provide leadership and energy to its Regulatory Affairs team. This is an exceptional opportunity to join a corporate culture that is known for having an innovative and growth oriented vision. Responsibilities include:
1) Represent regulatory on commercial teams that direct marketed product activities
2) Organize and manage all regulatory aspects of product development programs
3) Review technical reports and summary documents (clinical, pharmacology & toxicology) for adherence to regulatory guidelines, strategies, and commitments
4) Schedule and track project specific and operational activities relating to the Regulatory Department
5) Keep abreast of all pertinent laws, regulations and guidance and provide insight on current regulations and guidance documents relevant to product development projects
6) Provide subsequent recommendations for regional regulatory strategies and implementation activities
7) Participate in due diligence for licensing activities
8) Prepare Regulatory Standard Operating Procedures and provide regulatory review of SOPs from other departments, as necessary
9) Keep apprised of new regulations, standards, policies and guidance issued by relevant regulatory authorities that may impact the company
10) Provide regulatory guidance to clinical affairs, quality systems, manufacturing and development group
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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 who have recent experience in regulatory affairs
This role is a great opportunity for the right person looking to advance their career with a great company.
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.