Regulatory Affairs Manager
At ProClinical, we are seeking a talented individual to fill the role of Regulatory Affairs Manager, based in New York. The successful candidate will be responsible for leading, coordinating and preparing a wide variety of drug product registration functions including US ANDA, NDA, IND, DMF submissions and their associated regulatory correspondence.
- Prepare, review and file new ANDA, NDA, IND and DMF for the FDA in eCTD format.
- Prepare, review and file all post marketing activities.
- Manage regulatory correspondence.
- Provide regulatory guidance to relevant departments.
- Supervise, prepare and submit drug product labeling generation and monitor changes.
- Contact FDA and participate in Pre-IND and Pre-NDA meetings. Prepare, review and filing of the package for these meetings.
- Communicate and follow up with FDA for any issues, responses, status for pending and approved applications. Respond to FDA's request expeditiously.
- Review and provide guidance for Citizen Petitions.
- Prepare, review and file suitability petitions and controlled correspondence.
- Remain current with FDA regulations.
- Review, approve and file any promotional or advertising material.
- Review and approve all change controls from manufacturing sites.
- Maintain all documents on approved and filed products.
- Participate in decision making process with other applicable departments.
- Evaluate performance of the individuals in the department.
Skills And Qualifications
- MS in Life Sciences and 3-4+ years' experience in the generic pharmaceutical industry (supervisory experience required).
- Strong background in CMC aspects of drug product registration, knowledge of US drug registration (NDA, ANDA, DMF & INDs) and US drug product labeling requirements.
- Excellent written, verbal and interpersonal communication skills.
- Strong knowledge of Microsoft Office Suite.
- Some travel required.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Tong at (+1) 646-878-6308 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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