Regulatory Affairs Associate
Eugia US LLC, Princeton Junction, NJ, United States
Division Overview
Eugia is US-based independent specialty pharmaceutical company focused on generic sterile injectables, oncology, hormones, and ophthalmic medicines. Eugia has best-in-class, dedicated manufacturing and R&D capabilities to meet customer needs as they emerge. We are committed to consistently providing our customers with high quality specialty medicines. Eugia’s mission is to make the process of buying specialty pharmaceutical products an experience customers look forward to, and our vision is to become synonymous with excellent customer service and continuously improve upon this excellence by being transparent, responsive, and consistent. We are expanding Eugia’s capabilities to include the manufacture of highly complex injectables to answer that need. Eugia is the partner of choice to deliver on the promise of generic specialty pharmaceuticals. Job Overview
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. 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. This is not an exhaustive list of all responsibilities, duties, skills, efforts, or requirements associated with the role. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned with or without notice. Qualifications - Skills & 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. Education & Experience
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. Compensation
The annual base salary range for this position is $60,000.00 to $75,000.00 depending on factors such as experience level, knowledge, skills, and abilities. Final compensation decisions will consider these and other relevant business needs. In addition to base salary, this position is eligible for an annual bonus, with target percentages varying by role. The total compensation package may also include discretionary incentives and role‑based monthly allowances (e.g., cell phone or car allowance, where applicable). Health and Welfare Offerings
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. Physical Requirements
OFFICE POSITION - While performing the duties of this job the employee is required to: • Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment • Specific vision abilities required by this job include close vision requirements due to computer work • Light to moderate lifting is required • Moderate noise (i.e. business office with computers, phone, and printers, light traffic). • Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. Blood/Fluid Exposure Risk
Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.
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Eugia is US-based independent specialty pharmaceutical company focused on generic sterile injectables, oncology, hormones, and ophthalmic medicines. Eugia has best-in-class, dedicated manufacturing and R&D capabilities to meet customer needs as they emerge. We are committed to consistently providing our customers with high quality specialty medicines. Eugia’s mission is to make the process of buying specialty pharmaceutical products an experience customers look forward to, and our vision is to become synonymous with excellent customer service and continuously improve upon this excellence by being transparent, responsive, and consistent. We are expanding Eugia’s capabilities to include the manufacture of highly complex injectables to answer that need. Eugia is the partner of choice to deliver on the promise of generic specialty pharmaceuticals. Job Overview
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. 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. This is not an exhaustive list of all responsibilities, duties, skills, efforts, or requirements associated with the role. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned with or without notice. Qualifications - Skills & 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. Education & Experience
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. Compensation
The annual base salary range for this position is $60,000.00 to $75,000.00 depending on factors such as experience level, knowledge, skills, and abilities. Final compensation decisions will consider these and other relevant business needs. In addition to base salary, this position is eligible for an annual bonus, with target percentages varying by role. The total compensation package may also include discretionary incentives and role‑based monthly allowances (e.g., cell phone or car allowance, where applicable). Health and Welfare Offerings
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. Physical Requirements
OFFICE POSITION - While performing the duties of this job the employee is required to: • Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment • Specific vision abilities required by this job include close vision requirements due to computer work • Light to moderate lifting is required • Moderate noise (i.e. business office with computers, phone, and printers, light traffic). • Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. Blood/Fluid Exposure Risk
Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.
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