Job description

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:
This Senior Manager, Regulatory Affairs will be responsible for the regulatory affairs functions across sterile products primarily injectables but inclusive of ophthalmic, inhalation and oral solid products. The review of Review of ANDA/Amendment/Supplement/Annual Report/PADER/CCs/Meeting Request/Field Alert Report/Recall Letters/AERs/CCFs andany relevant documents of Eugia Pharma Specialities prior to submission to FDA will fall to this position. It is expected for this individual to maintain up-to-date working knowledge on relevant regulations, guidance, and the current regulatory requirement.

This role will be based onsite in East Windsor, New Jersey

Responsibilities:
Pre-submission review of Eugia Pharma sterile product and non-sterile product ANDA documents for completeness and conformance. Coordinate with project partners and/or 3rd party manufacturers to assure required tasks are performed and documentation is timely and is suitable / acceptable for submission.
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.
Responsible to support Sales / Marketing Team for New Product Launch activity (from Regulatory perspective), as and when needed.
Support a Pharmacovigilance Team (from Regulatory perspective), as and when needed.
Maintain and update internal RA Databases, as and when required.
Responsible to communicate with the Agency as an US Agent for Eugia Submissions.

Qualifications - Skills & Requirements:
Familiarity with applicable regulations and guidance including current Office of Generic Drugs submission requirements, ICH, cGMP, CFR etc. (mandatory).
Knowledge of US drug regulatory requirements (mandatory).
Prior experience with compilation and review of documents for FDA submissions.
Regulatory Operations experience (submission compilation and publishing) is preferred.

To protect the safety of our workforce, customers, and communities, the policy of the Company requires all employees and workers in the U.S. to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. All applicants seeking a role located in the U.S. must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.

Education & Experience:
BS degree in a health or scientific discipline, preferably Pharmacy, Chemistry, Biology. An advance degree is desirable.
Minimum 6 years of pharmaceutical Regulatory Affairs experience preferably in generics including at least 1 year experience in review of labeling / eCTD Module 1 documents (mandatory).
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. Additional Physical Requirements:
No Additional Requirements
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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