Senior Associate, Labeling Strategist, Regulatory Affairs job in Paramus
|Employer:|| Glenmark Pharmaceuticals Inc., USA|
|Category:||Research and Development|
|State:||New Jersey (NJ)|
Position Summary :
Under direction from managers, this position will undertake the responsibility for preparation, review and approval of labeling to support US pre-approval and commercial efforts. The incumbent will serve as a liaison to the US FDA, internal Glenmark cross-functional teams, and external third party entities. The incumbent will work closely with the Regulatory Affairs teams to ensure timely and comprehensive support to meet business unit timelines for all submissions containing labeling components
Key Responsibilities :
- Provide labeling guidance to all Regulatory team and all cross-functional stakeholders to ensure Glenmark drug product labeling is compliant with all applicable regulations and guidance.
- Manage labeling elements with external collaborations in accord with stated departmental and corporate timelines.
- Provide regulatory support for original ANDAs, responses to deficiency letters for pending ANDAs, and post-approval supplements, specifically performing labeling reviews and support.
- Support maintenance of Structured Product Labeling (SPL).
- Monitor US FDA's website for RLD Updates.
- Interact with legal team to assure labeling meets the terms of patent and exclusivity certifications and marketing authorizations.
- Work with marketing team to assure packaging configurations and branding efforts are supported in accord with regulatory requirements and best practices.
- Work with pharmacovigilance team to provide labeling information required for Periodic Adverse Drug Experience Reports (PADERs).
- Interact with the US FDA as needed to assure current guidance is accurate and resolve any issues or challenges as directed by managers.
- Bachelor's degree required in chemistry, biochemistry, pharmacy, biology or related scientific discipline.
- Equivalent experience will be considered.
- Minimum 4 to 5 years pharmaceutical regulatory experience with substantial labeling review experience.
- Demonstrated experience interacting with the US FDA and other state and/or local regulatory authorities.
- Working knowledge of Code of Federal Regulations and Guidance for Industry applicable to generic drug products, with particular emphasis on labeling regulations and guidance.
- Strong verbal and written communication skills.
- Experienced background working with labeling management and related computer software applications.
- SPL software
- Strong, effective, demonstrable communication skills with US FDA and other state and/or local authorities.
- Exceptional communication skills, interpersonal skills, problem solving abilities.
- Cross-cultural competency and international work experience are a plus.
- Must be able to work independently, exercise sound judgment, and make informed decisions.
- Exception attention to detail required due to accuracy requirements for drug product labeling components.