Our client is looking for a Senior Manager of Regulatory Affairs, Tissue with solid regulatory management experience from the pharmaceutical industry. Specifically, we are looking for someone who is able to handle the following responsibilities?
1) Plan, schedule and direct regulatory activities and programs
2) Advice and manage the regulatory teams, and review ongoing projects
3) Provide input on budget requirements, and monitor project and program costs
4) Negotiate with external agencies as needed to resolve key regulatory issues and expedite approvals of product and services
5) Review and prepare responses to inquiries from regulatory authorities relating to product registrations
6) Primary contact and represent all interactions with regulatory agencies for assigned projects
7) Define and maintain strategic alliances regulatory metrics for management review
8) Review and revise existing SOPs relating to regulation and revise where necessary
9) Submit and review translations of regulatory documents from existing and new sites
10) Provide appropriate IRB and other regulatory documents to support development of new tissue supply sites
More questions? Want to know the Salary range? Keep reading.
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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 regulatory affairs management
This could be an once-in-a-lifetime opportunity for the right person who is looking to make a positive career change. If you think this could be you, please apply!
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.