Responsibilities :
Compile high quality and right first-time submissions (Abbreviated New Drug Applications / New Drug Applications, amendments, supplements, annual reports, etc.
Draft ANDA / NDA modules for original applications, amendments, supplements, etc., for submission to FDA.
Maintain full awareness of all regulatory activities on assigned Project(s) and ensure that the project deadlines and performance standards for these projects are established and met.
Also, work with internal and external stakeholders to manage submission schedules.
- Represent regulatory affairs in project team meetings and provide regulatory guidance to team members in determining appropriate actions in order to meet scheduling timelines and / or in resolving technical issues.
- Contribute to the preparation of controlled correspondences and meeting packages related to pre and post ANDA / IND / NDA meetings with FDA.
- Review technical reports, summary documents and evaluate change controls (chemistry, manufacturing and analytical controls) for appropriate content and formulate strategies with minimal guidance, to ensure proper filing categories in accordance with FDA requirements.
- Point-of-contact with FDA for exchange of information, as required.
- Assess and remain current with new and changing guidance / regulations.
- Train and provide guidance to junior department members in above areas, as required.
- Identify the need and implement improvements to existing department procedures and processes or SOPs, where applicable.
Requirements :
- Bachelor's degree required in a scientific discipline such as Chemistry, Biology, or Pharmacy. Graduate degree preferred.
- Minimum 8 years' experience in the Pharmaceutical Industry. A minimum of 5 years' previous experience in drug regulatory affairs required.
- Must have a minimum of 2 years of regulatory experience in sterile dosage form. Experience with inhalation or transdermal dosage forms is a plus.
- Excellent attention to detail and organizational skills.
- Strong analytical and problem-solving abilities.
- Effective communication and interpersonal skill.
- Ability to work both independently and collaboratively in a team environment.
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