What are the responsibilities and job description for the Regulatory Affairs Associate position at Arna Pharma Inc?
About the Company :
Arna Pharma is part of a global alliance of pharmaceutical companies operating in over 20 countries, including Australia and New Zealand. We develop, manufacture, and market our own and third-party pharmaceutical and nutraceutical products. Our mission is to enhance patient well-being through scientific excellence and make a positive impact worldwide.
About the Opportunity :
We are seeking a Regulatory Affairs Associate to join our team in the United States. This role will support Arna Pharma Inc. as it expands into the US market, focusing on product life cycle management, regulatory submissions, and compliance with FDA requirements.
Job Summary :
The Regulatory Affairs Associate will play a crucial role in ensuring compliance with US regulatory standards, managing state licensing, and supporting promotional material reviews. This position will report to the VP of Regulatory, Medical, and PV and will be based in Austin, Texas.
Key Responsibilities :
- Regulatory Submissions : Assist in filing ANDA / NDA submissions and ensure compliance with FDA requirements for marketing and promotional materials.
- Product Life Cycle Management : Support new product registrations for prescription and non-prescription medicines.
- State Licensing : Oversee or manage state licensing for Arna Pharma Inc.
- Promotional Material Review : Review and vet promotional materials to ensure compliance with FDA regulations.
- Pharmacovigilance : Contribute to pharmacovigilance activities as required.
- Collaboration : Work closely with overseas regulatory business partners and internal teams such as Quality, Manufacturing, and Business Development.
Experience and Qualifications :
Work Environment :
This role offers a collaborative environment with the option for office-based or hybrid work arrangements.
What We Offer :
How to Apply :
If you are motivated by the challenge of ensuring regulatory compliance and supporting the launch of new pharmaceutical products in the US market, please submit your application, including your resume and a cover letter outlining your experience and qualifications.
Contact Information :
please send your resume to : HRAus@arnapharma.com
Location :
Job Type : Full-time
Work Arrangement :
Office-based or Hybrid
We look forward to hearing from you!