Sr. Regulatory Affairs Specialist will be responsible for the development of labeling for new and established products. Provides labeling regulatory support to assure that our company’s products are in full compliance with U.S. Federal regulations.
Provide labeling support to assure that our company’s products are in full compliance with U.S. Federal regulations.
Key Accountabilities -
% of Time
Labeling & Graphics
With some guidance, ensure all labeling applications are ready on time for submission by reviewing and approving labeling for content and accuracy of new products and make changes to existing products.
Maintain all labeling documentation and project files
Work with manufacturing concerning labeling changes and their implementation plans for labeling requirements. Track changes and provide support for implement labeling as needed.
Perform electronic compilation of the labeling supplements into eCTD format. Address FDA labeling comments and coordinate with CMC as needed for submission back to FDA.
Assist in the review of reference listed drug labeling for our generic product labeling and propose next action steps.
Create labeling artwork mark-ups and prepare labeling Word documents
Provide post-marketing support as needed
Lead, mentor and train junior staff
Education & Experience
- Bachelor’s degree in scientific or healthcare discipline
- 3 years regulatory affairs experience
- Experience with generic products preferred
- Knowledge of regulations relating to activities for Generic Labeling
- Knowledge of FDA and ICH guidelines pertaining to ANDA submissions and change control
- Proficiency with eCTD filing and SPL
- Proficient computer literacy
- Strong attention to detail
- Excellent oral and written communication skills, including editing documents
- Ability to manage multiple priorities
- Ability to work independently
Endo Pharmaceuticals - 21 months ago
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Endo Health Solutions, formerly known as Endo Pharmaceuticals, wants the pain to end, preferably through the drugs it acquires and markets....