Our client is a leading biopharmaceutical company and is currently seeking an accomplished Regulatory Affairs Manager to join the team. Here is an overview of the role:
1) Collaborate with colleagues in the regulatory organization to support global regulatory strategies
2) Develop and manage project plans and co-ordinate regulatory studies
3) Evaluate U.S. data sets to obtain the necessary regulatory approvals
4) Prepare and assemble new product submissions and manage and monitor the submission process
5) Prepare responses to questions in collaboration with subject matter experts
6) Provide regulatory support to commercial colleagues on business transitions and expansions for biological products
7) Respond to questions from customers and regulatory authorities and collaborate with the business teams on the identification and management of regulatory and stewardship issues
8) Develop and deliver the presentations to internal and regulatory audiences and relationship management with key stakeholders
9) Develop continuous and systematic knowledge in regulatory affairs matters
10) Keep systems and stakeholders up-to-date on labeling
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 biopharmaceutical industry is strongly preferred
4) Preference will be given to people who have recent experience in regulatory affairs
If you believe you have the ability to excel in this role, this could be the right opportunity to work with a great company in the biopharmaceutical industry.
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.