Regulatory Affairs Manager
Location : Pine Brook NJ US 07058
Job Type : Direct
Reference Code : 19889-AB1
Compensation : 80000.00 - 100000.00 USD/YEAR
Start Date : 07/18/2019
Hours : Full Time
Required Years of Experience : 5
Required Education : BS Science
Travel : No
Relocation : No
Job Industry : Pharmaceutical
Job Description :
- Permanent position for a North American Regulatory Affairs Manager to represent FDA regulatory affairs functions for the development of generic small molecule candidates by interfacing with multiple global research and operational teams to independently coordinate, compile and produce routine regulatory submissions including IND, NDA, and ANDA.
- Provide regulatory expertise on questions/issues that arise during product development.
- Support the global regulatory lead in the Implement and develop specialty product regulatory strategies for successful development and timely registration.
- Track timelines on regulatory deliverables and provide development project status updates by or identifying any issues that could impact the timely submissions.
- Serve as company's US regulatory representative by managing global regulatory submissions for projects.
- Reviewing manufacturing/quality change controls and assessing their impact.
- Ensure all regulatory submission documents are fully compliant with internal document standards. Manage and oversee appropriate quality reviews of documents.
- Evaluate all documents submitted to the FDA to ensure completeness, accuracy and in regulatory compliance.
Required Qualifications :
- BS in scientific discipline, MS or doctorate strongly preferred.
- Minimum 5 years of biotech/pharmaceutical industry regulatory experience.
- Experience in respiratory therapeutics is ideal.
- Experience with all aspects of regulatory affairs (CMC, clinical, nonclinical) for small molecules.
- Experience in and knowledge of leading IND and NDA submission teams for clinical trials.
- Detail oriented, quick-learning, self-starting, well organized with strong problem solving, critical and quantitative thinking, project management, interpersonal, communication and presentation skills.
- Ability to multitask and adhere to tight timelines;
- Ability to collaborate effectively with a diverse team on complex projects.
- Knowledge of US regulatory requirements pertaining to the development and registration of new and 505(b)(2) drug products.
- Knowledge of drug combinations and 510ks.
- Knowledge of EU clinical trial/registration dossiers.
- Knowledge of Clinical and CMC aspects of regulatory affairs.
- Experience with Electronic Common Technical Document (eCTD) format.
Contact: Allan Berman
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