Regulatory Affairs Associate
Primary function of the Regulatory Affairs Associate is to serve as a regulatory liaison to clients and internal functional departments.
Assists in the implementation, execution and maintenance of quality systems to ensure Ash Stevens complies with regulatory requirements as propagated by the United States Food and Drug Administration (FDA) and similar international regulatory bodies. Principal assignments related to compliance will include writing documents, review of records and data, review and implementation of new or revised documentation to ensure that ASI drug regulatory requirements are met.
Participate in outside meetings, forums, etc. to ensure the latest thinking is applied to Regulatory and Chemistry, Manufacturing and Controls (CMC) strategies.
As talents and experience dictate, the Associate will interact with auditors from regulatory bodies and clients.
KEY DUTIES AND RESPONSIBILITIES:
1). Document Preparation and Review - 60%
Assist in the writing, preparation and/or review of documents to ensure compliance with FDA requirements, quality agreements and regulations.
Accurately authors and assembles documentation for client regulatory submissions. Reviews proposed product changes for impact on regulatory status of the product and provides regulatory guidance and support for development and production activities.
Partner with internal and external customers to assemble and review data in support of annual regulatory filings and in support of the preparation of the CMC portions of INDs, DMFs and NDAs, amendments and supplements.
Support maintenance of regulatory reporting schedules.
Assist in document record maintenance and destruction in accordance with SOPs.
Provide other regulatory and quality assurance support as needed to colleagues within ASI.
2). Reports - 20%
The Associate will assist in the development and preparation of regulatory reports for the file or for submission to regulatory bodies. In addition, the Associate will participate in the preparation or review of associated documentation, such as, Cleaning Validation Reports and Process Performance Qualification Protocols and Reports.
3). Continuous Learning - 10%
Maintain current knowledge of FDA and other pertinent Health Authority regulations for effective regulatory submissions. Remain current on FDA updates including new policies and guidances.
4). Meetings with customers and investigators - 10%
Participate in discussions with customers and investigators.
Education and Experience:
- Minimum Bachelor’s degree in science, chemistry or chemical engineering degree is preferred.
- 2-4 years’ experience in regulatory affairs or related field in pharmaceutical manufacturing preferred
- Experience with the application of Design Of Experiment (DOE) and Quality by Design (QbD) a plus.
- Knowledge of GMP requirements (21 CFR Part 211 and/or ICH Q7a)
- Knowledge of Drug Regulatory requirements, specifically as relates to preparation of
- CMCs, DMFs or CTDs.
This position is intended as a mid-level position. As the individual develops an understanding of internal and external requirements, opportunities for growth are available.
Essential Skills and Abilities
- The successful candidate should have good organizational and planning skills
- The successful candidate should have strong written, verbal and interpersonal communication skills.
- The successful candidate should possess effective skills for developing, performing, evaluating, troubleshooting within a scientific/technical discipline.
- RAC and/or related professional certifications or willingness to obtain such certification is preferred.
Physical Requirements/Work Environment
- Must be able to lift/push/pull up to 30 pounds occasionally
- Ability to work on a computer the majority of the day
- Potential limited exposure to hazardous chemicals
- Personal protective equipment including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes may be required in areas associated with this position
Applicants must be authorized to work in the US for any employer without visa sponsorship.
Please send resumes to:
Ash Stevens Inc.
18655 Krause St.
Riverview, MI 48193