Regulatory Affairs Manager
Job Req # 573977
Global Pharmaceutical Company is looking for:
POSITION: Regulatory Affairs Manager
SALARY: $110-130k + Bonus
LOCATION: West Caldwell, New Jersey
EXPERIENCE: 3-5+ Years experience in Pharmaceutical regulatory affairs with Generics including writing ANDA, NDA, and INDs
SPONSORSHIP: No Sponsorship Available / No H1B
RELOCATION: Assistance Available in the form of a Lump Sum
Must have experience writing part of an ANDA, NDA submission.
This individual will be responsible for managing a regulatory group within a global company.
Summary of the functions of this Manager's Team:
Responsible for writing drug regulatory submissions/licenses including New Drug Application (NDA), ANDA's, INDs, NDA Supplements: Prior Approval Supplements (PAS), Changes Being Effected (CBE), IND Amendments and Annual Reports (AR).
This position is responsible for managing various regulatory licensing activities. Examples include, but are not limited to:
Orchestrate the format and information in the development of regulatory submissions including New Drug Application (NDA), ANDA's and INDs in accordance with the current FDA requirements.
Write domestic drug regulatory submissions/licenses including New Drug Application (NDA), ANDA's, INDs, NDA Supplements: Prior Approval Supplements (PAS), Changes Being Effected (CBE), IND Amendments and Annual Reports (AR).
Write responses to regulatory authority deficiency questions regarding product information or issues and submit Amendments to NDA Supplements/INDs.
Ensure accuracy of Clinical documents in compliance with Clinical Trial regulations for submission to FDA for execution of Clinical Studies.
Ensure timely and accurate submissions per business objectives and determine deliverables that are aligned with regulatory strategy.
Coordinate preparation of meeting packages and materials for FDA meetings and interactions.
Monitor applicable regulatory requirements; assure compliance with corporate and external standards and guidance documents.
Develop and maintain standard operating procedures or local working practices ensuring regulatory compliance.
Position Requirements: Excellent organizational and communications skills is a must. This position also requires teamwork, problem-solving, ability to multi-task and motivate resources in the gathering of information required. Experience with electronic drug submissions and knowledge of Quality and Regulatory requirements, especially those with a drug focus would be very helpful. This person must be able to work independently with minimal guidance.
Minimum BA or BS required, preferably in a scientific or health related discipline
Minimum of 3 years of experience in Regulatory Affairs and Quality Assurance with Pharma and/or Medical Device firms
Understanding of related disciplines in a FDA regulated environment, including cGMPs
Must have drug submission experience including ANDA
Windows based applications: MS Word, MS Excel, MS Power Point, and Adobe Acrobat.
Familiar with the various FDA databases.