Industry - Pharma / Biotech / Clinical Research

Category - Operations

Job Type - Permanent

POSITION SUMMARY: The Regulatory Affairs (RA) Scientist will serve as a regulatory liaison to clients and internal functional departments. The incumbent will assist in the implementation, execution, and maintenance of quality systems to ensure Ash Stevens Inc. complies with regulatory requirements as propagated by the United States Food and Drug Administration (FDA) and similar regulatory bodies. Principal assignments related to compliance will include authoring documents, review of records and data, review and implementation of new or revised documentation to ensure that Ash Stevens Inc.'s drug regulatory requirements are met. Participate in outside meetings, forums, etc. to make certain the latest thinking is applied to Regulatory and Chemistry, Manufacturing, and Controls (CMC) strategies. The RA Scientist may also interact with auditors from regulatory bodies as well as clients.

To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

- Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.

- Consistent support and practice of all Ash Stevens' mission and values.

- Identify and protect the original technical information as part of the company property.

KEY RESPONSIBILITIES:

- Documentation Preparation and Review: Assist in the writing, preparation, and/or review of documents to ensure compliance with FDA requirements, quality agreements, and regulations. Accurately author and assemble documentation for client regulatory submissions. Review proposed product changes for impact on regulatory status of the product and provide regulatory guidance and support for development and production activities. Participate with internal and external customers to assemble and review data in support of annual regulatory filings and the preparation of the CMC portions of INDs, DMFs, NDAs, amendments, and supplements. Support maintenance of regulatory reporting schedules. Assist in documentation record maintenance and destruction in accordance with SOPs.

- Reports: Assist in the development and preparation of regulatory reports for the file or for submission to regulatory bodies. In addition, the incumbent will participate in the preparation and review of associated documentation such as Cleaning Validation Reports and Process Performance Qualification Protocols and Reports.

- Continuous Learning: Maintain current knowledge base of FDA and other pertinent health authority regulations for effective regulatory submissions. Remain current on FDA updates including new policies and guidance.

- Meetings with Customers and Investigators: Participate in discussions with customers and investigators as required.

EDUCATION/EXPERIENCE.

- Bachelor's degree in science, chemistry or chemical engineering is required.

- Two (2) to Four (4) years' experience in regulatory affairs or related field in pharmaceutical manufacturing strongly preferred.

- Experience with Design of Experiment (DOE) and Quality by Design (QBD) application is a plus.

- Knowledge of GMP requirements (21CFR Parts 210, 211 and ICH Q7).

- Knowledge of drug regulatory requirements, specifically as it relates to the preparation of CMCs, DMFs, and/or CTDs is a plus.

- RAC and/or related professional certifications or willingness to obtain such certification is preferred.

Job competencies :

- Excellent organizational and planning skills.

- Strong written, verbal, and interpersonal communication skills.

- Have the ability to develop, perform, evaluate, and troubleshoot within a scientific discipline.

Job conditions :

The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical Demands:

- Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected.

- Long periods of standing and walking can be expected in this position.

- This position may require long periods of sitting, typing, computer entry or looking at a computer.

Work Environment:

- Piramal Pharma Solutions is engaged in the business of pharmaceutical research and contract pharmaceutical manufacturing. As such, all PPS staff work in or nearby either chemical/pharmaceutical research or chemical/pharmaceutical manufacturing equipment and processes.

- Potential limited exposure to hazardous chemicals.

- Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position.

Contact - Shannon Huver :

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