Job Description
Senior Associate, Regulatory Affairs
- Full-time, permanent position
- Pay Rate : Commensurate with experience.
- On-site Princeton, NJ
If you're passionate about making a meaningful impact in the development of affordable medications, this role is your opportunity to contribute to an essential cause.
We at Raise are hiring on behalf one of our key clients in the generic pharmaceutical space. They are one of the industry leaders in the soft gel capsule space for both prescription and over-the-counter medications.
They’re looking for skilled regulatory professionals like you to help complete meaningful and impactful projects. This is a role where you can learn and grow alongside an experienced team.
If you want a job where you can build skills with an industry leader, this could be it.
They’re hiring right now; if you’re interested, apply today for your chance to join a great place to work.
Our client takes pride in their people. When you join their team, you’ll find a workplace that facilitates challenge, achievement, and growth.
Responsibilities :
- Prepare regulatory submissions, including Original ANDAs, Amendments, Annual Reports, Supplements, and PADERs for applications.
- Engage in project calls and work closely with internal and external project managers and contract manufacturers to ensure the timely availability of documents for submission.
- Review supporting submission documents for accuracy and adequacy, addressing any questions or concerns to Regulatory Affairs management immediately.
- Prepare Annual reports and keep updated with the Agency's expectations, applying this knowledge to future submissions to avoid similar deficiencies.
- Ensure that facilities used in applications comply with GDUFA requirements (site identification, facility fees).
- Initiate and review change requests from internal teams and CMOs, ensuring compliance by closing or requesting extensions on change controls as needed.
- Assist in maintaining regulatory trackers for original submissions, Amendments, Supplements, Annual reports, and deficiency responses.
- Monitor and ensure compliance with commitments made to Regulatory Agencies.
- Perform miscellaneous tasks assigned by management.
Qualifications :
- Degree in Science with at least 5 years of experience in the pharmaceutical industry.
- Understanding of regulations relating to generic pharmaceuticals and the generic drug approval process.
- Capable of conducting a technical review of documents submitted in applications.
- Strong organizational skills and the ability to multitask.
- Excellent written and verbal communication skills.
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