Reporting To: Director, Regulatory Affairs
Location: Hauppauge, NY
- Prepare, coordinate, and manage regulatory submissions of NDAs/ANDAs in accordance with applicable FDA guidelines (CBE-30, CBE-0, PAS, annual reporting)
- Stay up-to-date on current GDUFA/MDUFA requirements, FDA facility registration (through Electronic Submission Gateway (ESG).
- Assist with product development projects
- Prepare and approve product dossiers and various regulatory documents
- Support customers’ registration process
- Support various departments as necessary with regulatory guidance
- Bachelor’s degree required, Masters preferred in regulatory affairs, legal, compliance or related
- At least 3 years of experience working in pharmaceutical Regulatory or Compliance required
- Experience in compiling documents in CTD format
- Experience in filing annual and periodic reports for NDA/ANDA submissions
- Experience with eCTD software preferred.
- Ability to read and interpret regulatory guidelines as they apply to submission documents
- Demonstrate understanding of finished product manufacturing technologies
- Proper knowledge of the industry regulations (Pharma, Legal) including 21 CFR (Code of Federal Regulation), cGMPs as related to US FDA and EU EMEA
- Analytical; ability to compile, manage and interpret data
- Clear and concise communicator; effectively present and write
- Self-starter; results oriented, driven to succeed with a sense of urgency
- Problem solver
- Team Player who has demonstrated success leading a cross-functional team
This is an exciting opportunity to join our expanding Regulatory Affairs team. The purpose of the role is to facilitate the filing of FDA submissions and product registrations to the relevant regulatory authorities.
CPC is offering a professional, stable work environment with excellent opportunity for career advancement in a dynamic company, a competitive salary and a comprehensive benefits package, which includes medical, dental, life insurance, paid time-off and 401(k) plan with matching contributions.