Regulatory Affairs Associate

Hays • Trenton, NJ

430d

About The Position

The Regulatory Affairs Associate at HAYS is responsible for supporting the Regulatory Team in maintaining and registering new products and state wholesaler licenses as required by the FDA and other regulatory agencies. This role involves a variety of regulatory support tasks, including the submission of electronic documentation, preparation of FDA submissions, and ensuring compliance with licensing requirements.

Requirements

• Minimum B.S. in scientific discipline, M.S. preferred.
• At least 5 years of experience in the pharmaceutical industry including 3 plus years regulatory affairs experience in both pre and post approval pharmaceutical FDA submissions.
• Knowledge of filing and approval process for generic drug products.
• Experience in dealing with the FDA - OGD is desirable.
• Experience writing and assembling supporting documentation for ANDAs and other regulatory filings, including familiarity with CTD format and eCTD submissions.
• Knowledge of product development milestones and compliance requirements.
• Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data.
• High degree of motivation and initiative are required.
• Proven ability to anticipate challenges and negotiate through them to achieve desired outcomes.
• Detail-oriented with the ability to detect and correct errors and/or inconsistencies in a variety of documents.
• Excellent communication, verbal and written English skills and ability to work across cultures and time zones.
• Ability to work successfully within a team/collaborative environment with a high level of professionalism.

Nice To Haves

• Understanding of ICH and FDA guidelines.
• Understanding of R&D processes required for ANDA submissions.
• Knowledge of regulations/best practices for Rx drug storage/distribution including familiarity with the using track and trace/ePedigree requirements.
• Proficient with Adobe, eCTD software and Microsoft Office applications.

Responsibilities

• Provide regulatory support to all functional groups.
• Submit electronic documentation through the ESG (Electronic Submissions Gateway).
• Create, organize and coordinate the preparation of FDA submissions including post approval changes and PLAIRs (Pre-Launch Activities Importation Requests).
• Participate in the preparation and submission of requisite Labeling updates, Annual Reports, and PADERs (Periodic Adverse Drug Experience Reports) for approved ANDAs.
• Respond to queries from the FDA.
• Assist with Pharmacovigilance, Product Complaints, and Medical Information functions for the U.S. Generics business.
• Ensure compliance with licensing requirements for business in the states, for warehousing activities, and other mandatory drug licensing requirements.
• Foster collaborative, efficient, and effective working relationships with internal teams in India and the US.
• Monitor and communicate new regulatory requirements and/or review trends to affected functional areas such as R&D, Quality, Operations, Sales, and Marketing.
• Review product dispositions and verify incoming shipments and release as necessary.
• Additional responsibilities may be assigned as appropriate.

What This Job Offers

• Job Type: Full-time
• Industry: Administrative and Support Services
• Education Level: Bachelor's degree