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In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.
The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens.
Rising Pharmaceuticals, a growing generic pharmaceutical company, and a division of Aceto Corporation has an immediate need for an experienced Regulatory professional.
Senior Regulatory Affairs Associate
This position will be responsible for the compliance with federal, state, and local regulations for generic pharmaceutical products reporting to the Head of Regulatory Affairs at Rising Pharmaceuticals.
This position will be
Assist in preparation for submission: Original ANDA’s, Prior Approval Supplements, CBE-30s, CBE-0s, 180-Day Supplements, DLA Amendments, and Notifiable Changes.
Assembly of ANDA submissions.
Work with partners to provide regulatory support during product development
Organize regulatory documentation and support FDA audits
Review of labeling information and support SPL submissions
Preparation of post marketing reports such as 15-Day and Periodic ADEs, Annual reports, etc. compiling relevant information provided by the partner CMOs.
Communicate and provide information to partners upon request.
Track Regulatory activities via project management tools such as excel, MS project, etc.
Organize and update Regulatory files in Novo space and internal drives.
Provide presentation material for management updates
Work closely with partners and CMOs for labeling development and review.
For confidential consideration, please submit resume and salary requirements to email@example.com.
The ideal candidate will possess a B.S. in Science combined with a minimum of 5 years’ experience within the generic pharmaceutical industry with minimum 5+ years in Regulatory Affairs. In addition, knowledge of FDA related regulations, ability to utilize data management tools, including FDA databases, Pharma Database, Excel. Knowledge and comprehension of Code of Federal Regulations requirements (21 CFR 211 GMP’s and 21 CFR 314 ANDA’s). Knowledge and comprehension of applicable FDA regulatory guidelines and compendia requirements. Excellent oral and written communication skills.
Rising Pharmaceuticals is an industry leader in marketing and distributing niche generic prescription pharmaceutical products covering a variety of therapeutic areas and dosage forms. We also market a few legacy OTC products. We are focused on the development of Abbreviated New Drug Application (ANDA)-based generic products through our global network of development and manufacturing partners and have a robust emerging pipeline of niche pharmaceutical products.