Regulatory Affairs Associate

Orexigen Therapeutics, Inc. Morristown , NJ 07960

Posted 2 months ago

About Currax

Currax Pharmaceuticals LLC is a specialty pharmaceuticals company focused on providing increased access to life-changing medications for patients and healthcare providers. We seek to improve patient health and quality of life through the acquisition and commercialization of medications, including Contrave, Silenor, Treximet, ONZETRA Xsail, and a portfolio of generic medications.

At Currax, we take pride in our mission to serve patients, and we value authenticity and collaboration in our workplace. As we experience an exciting period of accelerated growth, our organization is rich with opportunities for our people to gain hands-on experience and fulfill career aspirations while making a direct impact on the lives of patients we serve.

About the Role

The Regulatory Associate will be part of the Regulatory Affairs team reporting to the Director of Regulatory Affairs. The associate will be responsible for supporting the regulatory activities for Currax current products, including preparation of regulatory submissions, management of regulatory documents, quality check for submission package, development of regulatory SOPs, and other duties as business needs require.

Responsibilities

  • Assist in the preparation of post-approval submissions for NDA/IND to appropriate regulatory agencies, including Annual Reports, periodic safety updates, supplements, amendments, meeting requests, briefing packages.

  • Provide support of the regulatory document management such as archiving published submissions and agency correspondences, creating and maintaining chronology logs.

  • Critically review submission documentation and provide input to respective departments for necessary revisions.

  • Provide regulatory support and guidance to the technical, medical/clinical team with post marketing CMC changes, labeling and packaging review, and phase IV clinical trials, etc. to ensure compliance.

  • Perform thorough QC and ensure consistency, completeness, accuracy, and adherence to regulations and applicable guidelines for all regulatory submissions.

  • Coordinate review of labeling and promotional materials.

  • Interact with functional team members to coordinate/facilitate procurement of documentation required for regulatory submissions.

  • Create and update departmental standard operating procedures (SOPs)

Required Qualification & Skills

  • Bachelor's degree in Life Science or other relevant disciplines

  • Minimum 3 years of experience within pharmaceutical regulatory affairs

  • Experience with preparing regulatory submissions, including INDs and NDAs

  • Pharmaceutical CMC related regulatory experience with post-approval emphasis is preferred.

  • Ability to evaluate regulatory documents and determine appropriate action

  • Ability to work effectively in cross-functional teams

  • Excellent written and verbal communication skills

  • Excellent organizational and time management skills, ability to manage multiple projects

  • Strong attention to detail

Currax is committed to the health and well-being of our employees and families and offers a comprehensive benefits package. Available benefits include medical, dental, and vision coverage, 401(k) plan with company match, paid time off and holidays, and other benefits to support your physical, financial, and social well-being.

Currax is an equal opportunity employer and complies with all applicable laws prohibiting discrimination based upon age, ancestry, color, creed, disability, marital status, medical condition, genetic information, military and veteran status, national origin, political activities or affiliation, race, sex, gender, gender identity and gender expression, sexual orientation, as well as any other category protected by law. Read our full EEO statement at http://www.curraxpharma.com/careers/eeo-statement/


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Regulatory Affairs Associate

Orexigen Therapeutics, Inc.