Job Description
Primary responsibilities are to manage, prepare and submit regulatory submissions by
successfully coordinating with the Manager for priorities; while maintaining compliance with
cGMP requirements, FDA, OSHA, EPA, and DEA.
Responsibilities :
- Trains Regulatory Associates
- Collaborates with R&D, QC and Production Managers
- Handles all aspects of regulatory submissions (i.e. ANDA and NDA)
- Assists associates, coordinators, analysts, auditors and specialists as needed
- Handles and completes special projects as required
- Comply with FDA guidelines/Company Policies of Data Integrity
- Other duties as required or delegated
Requirement :
- At least 2 - 3 years’ experience with technical writing preferred
- Minimum 5 years Pharma experience preferred
- Strong communication and problem-solving skills
- Proficient with Adobe PDF, Microsoft Office, XML, eCTD tools and advanced computer skills
- Continuous working knowledge of applicable FDA/ICH/DEA regulations
- Continuous working knowledge of applicable cGMP guidelines
Career Level
Senior / Team Leader
Job Specializations
Group Leader/ Manager
Qualification
Bachelor’s Degree in Pharmacy, Chemistry or
Scientific Discipline preferred
Year of Experience
2 to 3 years of experience.
