Regulatory Affairs Associate
About The Position
The Regulatory Affairs Associate will be responsible for regulatory functions for sterile products, primarily injectables also covering ophthalmic, inhalation and oral solid products. The preliminary review of ANDA/Amendment/Supplement/Annual Report/PADER/CCs/CCFs/OPDP and any relevant documents of Eugia Pharma Specialties will fall to this position. It is expected that this individual will maintain up-to-date working knowledge on relevant regulations, guidance, and the current regulatory requirement. This is onsite position in East Windsor New Jersey with one (1) day a week remote. Candidates must be legally authorized to work in the United States without the need for sponsorship. This position is not eligible for relocation assistance, and applicants must reside within a commutable distance to the office.
Requirements
- Strong knowledge of FDA regulations, guidance documents, and current regulatory requirements, with particular expertise in ANDA submissions, amendments, supplements, annual reports, PADERs, controlled correspondence, CCFs, and promotional materials (OPDP).
- Experience reviewing regulatory submission documents for completeness, accuracy, and compliance with eCTD and FDA standards.
- Familiarity with labeling requirements, NDC assignment, and maintenance of regulatory product listings.
- Ability to manage and update regulatory databases, track submission status, and maintain organized documentation.
- Proficiency in Microsoft Office and comfort with general data management tools.
- Effective communication skills to collaborate with Sales/Marketing and Pharmacovigilance teams, supporting new product launches from a regulatory perspective.
- Exceptional attention to detail, strong organizational skills, and the ability to work independently in a fast-paced, deadline-driven environment.
- Proven ability to work effectively as part of a team in a high-visibility, fast-moving environment.
- Must have a BS degree in a health or scientific discipline, preferably PharmD, Pharmacy, Chemistry, Biology. An advance degree is desirable.
- Minimum 1-3 years of pharmaceutical Regulatory Affairs experience preferably in generics including an experience in review of labeling / eCTD ANDA Module documents.
- Experience with eCTD format & content.
- Generic pharmaceutical experience highly preferred
Responsibilities
- Preliminary Pre-submission review of Eugia Pharma sterile product and non-sterile product ANDA documents for completeness and conformance.
- Issuance / maintenance of Eugia US NDC number list; review of proposed new product labeling for compliance to FDA requirements and corporate format; providing information and documents to Sales / Marketing as needed.
- Maintain and update internal RA Databases, as and when required.
- Responsible for supporting the Sales / Marketing Team for New Product Launch activity (from Regulatory perspective), as and when needed.
- Responsible to support a Pharmacovigilance Team (from Regulatory perspective), as and when needed.
Benefits
- Medical Insurance: Choice of four Horizon Blue Cross Blue Shield of New Jersey plans —Premiums and coverage vary by plan.
- Prescription Coverage: Included with medical insurance
- Dental Insurance: Choice of three plans - DHMO, Core PPO, or Buy Up PPO plans.
- Vision Insurance: Choice of two plans - Base and Buy Up options.
- Life and AD&D Insurance: Company-paid Basic Life and AD&D (1x annual salary up to a specified maximum), with optional Supplemental coverage.
- Disability Insurance: Voluntary Short-Term Disability (employee-paid); Long-Term Disability is company-paid.
- Flexible Spending Accounts (FSAs): Available for health care and dependent care expenses.
- Health Savings Account (HSA): Offered with HDHP enrollment; employee-funded.
- Voluntary Benefits: Identity Theft Protection, Critical Illness Insurance, Accident Insurance, and Legal Insurance (all employee-paid).
- Employee Assistance Program (EAP): Confidential support services at no cost.
- 401(k) Retirement Plan: Pre-tax and Roth contribution options available, with company match; vesting applies.
- Paid Time Off: Includes vacation, PTO, and company holidays (varies by role and tenure).
- Employee Referral Program: $1,000 bonus for each qualified hire you refer.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
