Senior Associate Regulatory Affairs - (Job Number: 0804916)

Senior Associate Regulatory Affairs - (Job Number: 0804916) DescriptionCentocor Research and Development, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Regulatory Affairs Associate located in Malvern, PA. Centocor Research and Development, develops innovative biomedicines. The world leader in monoclonal antibody production and technology, Centocor has brought critical biologic therapies to patients suffering from debilitating immune disorders. The Senior Regulatory Affairs Associate will assist with critical review of original manufacturing documentation for accuracy, completeness and clarity and will assist in writing and editing summary reports and CTD sections for health authorities based on this documentation.They will proofread and check documents for accuracy, wordsmith and simplify technical information, and assure submission documentation, record keeping and reporting meet inspection standards in accordance with regulatory requirements.The ideal candidate will also need to develop and maintain excellent working relationships with internal and cross-company project teams and will be expected to apply global regulatory requirements and guidance for documentation in the CTD and eCTD format.This position will provide input for process/facility/analytical changes. This position will have limited to some agency contact with supervision. The position will contribute on a limited basis to the regulatory content and strategy for submissions. A minimum of a Bachelors degree in Biology, Chemistry, Pharmacy or related scientific discipline is required. Advanced degree preferred. A minimum of 2 years of relevant pharmaceutical experience is required. Biotech/biologics experience is a plus.A basic knowledge of drug development (manufacturing processes, validation processes, and/or analytical methods), post approval activities, and a thorough knowledge of GMPs is required. A minimum of 2 years of relevant CMC regulatory experience is required, and/or 6 years of CMC experience. A working knowledge of the CTD is an asset (additional experience with global regulations, e.g. EU and ICH, is desirable). This position requires excellent written, verbal and communications skills and must be able to work well with colleagues. Must have good organizational skills, attention to detail and follow through. Advanced abilities for using Microsoft Office Suite (Word, Excel, PowerPoint, Visio) and Adobe Acrobat software is required. If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today! Apply Now