We have an opportunity for immediate hiring. See job description below.
Angelini Pharma Inc. – RA & QA Specialist
Summary
Angelini Pharma Inc., leader in infection control products, is searching for a highly motivated individual
to join our team to work in our Quality and Regulatory Affairs Department. We are specifically looking for an individual with at least 1-2 years of experience working with FDA (drugs and or devices) and/or EPA Regulated manufacturing companies. The position reports to the RA & QA Lead. This is a full time position and located in Gaithersburg, Maryland.
The Position
As a RA & QA Specialist, you will provide regulatory expertise to support compliance of OTC, antiseptic, medical device, and pesticide products in the U.S, Canada and South America. You will be an integral member of the team that is building our diverse product portfolio.
The RA & QA Specialist will be responsible for, but not limited to the following:
- Assist in preparation of regulatory strategies and identification of regulatory requirements for submissions
- Evaluate product and process changes for regulatory impact
- Provide a timely review of product labeling, advertising and promotional materials to assure compliance to domestic and global regulatory requirements
- Manage AE and Quality complaints (file, investigate, and communicate)
- Develop understanding and maintain current knowledge of global regulatory requirements related to product support, especially in S, Canada, and South America
- Proactively identify regulatory risks and develop strategies to mitigate risks
- Maintain regulatory files in a format consistent with requirements
- Maintain QMS system at a state of compliance, maintain vendor assessment, internal audit and CAPA files
- Work with CMO and distributor for proper product releases
- Lead training program
- Assume other duties as assigned by the Manager of Regulatory Affairs
Qualifications
Education and/or Experience (years):
- BS/BA in a Biology Science/Chemistry/Biotechnology or related degree area required.
- 1 to 2 years' experience in Regulatory Affairs in medical devices, pharmaceuticals and/or pesticides.
Knowledge, Skills and Abilities
Attention to detail with excellent organization; good documentation; verbal and written communication; and interpersonal skills. Ability to manage multiple high priority assignments. Proficiency with MS Suite required. Comfort and willingness to work with people from different cultural and skills background.
Compensation and Salary
For the performance of these responsibilities, Angelini Pharma Inc. offers a competitive salary.
Interested individuals should email your resume and cover letter to VSena-Weltin@angelini-us.com. Please reference the RA & QA Position.
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Valeria Sena-Weltin, M.S., RAC(US)
Angelini Pharma Inc.
RA & QA Lead
Gaithersburg, MD
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