Regulatory Affairs Specialist, Compliance
Provides regulatory expertise to drug development teams on the development and submission of labeling components for regulatory agency approval. Controls the consistency of labeling through review of content across the product family. Act as Regulatory sign-off for packaging and label reviews. Coordinate labeling review process for new product launches as well as updates to current packaging and labels. Process draft labeling for health authority submissions
- Complete FDA drug e-listings for prescription drug, over-the-counter (OTC) drug, device and biologic products to support compliance requirements for reimbursement.
- Support day-to-day compliance activities (e.g. change control for packaging/labeling,, distribution reports).
- Provide regulatory support for international product registrations as required, inclusive of certifications; compiling documentation as required by each country for product registration as well as government and manufacturing certifications; renewal of product registrations; researching country requirements for new product registrations.
- Draft and maintain applicable policies and procedures to support and define the regulatory affairs function.
- Perform other duties as needed.
Required Skills and Education:
- Bachelor’s degree in relevant field of study
- 5 years of relevant experience preferred.
- Equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above.
- All employees must read, write and speak fluent English
- In-depth knowledge of the scientific principles of the drug development process
- In-depth knowledge of regulations pertaining to drug product labeling
- Excellent oral and written communication skills
- Good project management skills
- Effective critical thinking skills
- Excellent attention to detail
Smith & Nephew is a global advanced medical technology business. We support healthcare professionals in more than 100 countries to improve the quality of life for their patients. Since 1856, when our founder T.J. Smith developed a new method for refining cod liver oil, and in World War One when his nephew led the supply of wound care products, to the present day, Smith & Nephew continues to pioneer health solutions.
Through our market leadership positions in Sports Medicine, Trauma, Orthopaedic Reconstruction and Advanced Wound Management, our 16,000 employees continue to improve outcomes and expand access, constantly striving to create value for healthcare professionals, patients, payers and shareholders.
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Job posted: 2020-07-10