Our client is looking for a Regulatory Affairs Associate with solid regulatory affairs experience from the pharmaceutical industry. Specifically, we are looking for someone who is able to handle the following responsibilities...
1) Involve in critical review of external and internal submission documents
2) Convey submission, advertising along with promotional requirements to internal clients
3) Conduct research regulatory needs for allocated regulatory affairs area
4) Oversee latest trends and merge new requirements in department toolkits and procedures
5) Involve in continuous enhancement activities as well as process re-engineering projects
6) Ensure established department timelines are attained
7) Interact with FDA sites through phone and written communications
8) Review and provide approval to OCNs and ECNs considering US along with international regulatory needs
9) Establish and manage regulatory information system comprising hard copy as well as electronically
10) Collaborate and interact with multidisciplinary groups to execute development and registration of marketing strategies for given projects
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 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 pharmaceutical 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.