Officer- Regulatory Affairs & Intellectual Property
📋 Role Overview & Responsibilities
Company:Established in 2017, AdvaGen Pharma is an integrated specialty pharmaceutical company, focused on providing innovative solutions for patients, customers, and partners by developing, manufacturing, and marketing high quality Specialty, Generic and OTC products. Job descriptionTo work for product registrations and product lifecycle management in various markets including US, Canada, UK, and AU involving follow-ups and ensuring alignment of regulatory team with organizational filing plan and timely filing of query responses to meet organizational goals. Interact with the regulatory team in India on a continual basis.To docket all communications from various regulatory agencies and ensure timely responses and actions towards the same.To liaise with the cross-functional teams and manufacturing/packaging sites to obtain needful documents and address deficiencies or obtain alignment for product registration or post-approval matters.To maintain accurate status of all product filings and share necessary updates to relevant stakeholders.To interact with attorneys and regulatory agencies as required for regulatory and patent matters including prosecution or litigation or regulatory meetings.To prepare submission documentation or controlled correspondences or requests for scientific advice when required for further review and submit the same to regulatory agencies.To maintain patent litigation status.
Years of Experience 3-5 years
Job Type: Full-time
Benefits:401(k)Dental insuranceHealth insurancePaid time offVision insuranceSchedule:8 hour shiftDay shiftMonday to FridayExperience:pharmaceutical industry: 3 years (Required)Ability to Commute:East Windsor, NJ 08520 (Preferred)Work Location: In person
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