Job Summary
A biotechnology company is searching for a person to fill their position for a Remote Regulatory Affairs Senior Manager.
Candidates will be responsible for the following:
- Planning and managing regulatory activities related to assigned projects
- Assisting in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions
- Ensuring regulatory submissions are maintained in compliance with regulatory requirements
Must meet the following requirements for consideration:
- BA/BS degree or equivalent experience in a pharmaceutical or health science field is required
- 7+ years' related experience is required
- Experience and knowledge in preparation of INDs (required) and NDAs (desirable), and supportive amendments
- Experience with CTD/eCTD
- Experience with publishing documents in Adobe Acrobat Professional
- Excellent oral and written communications skills are a must as are superior planning skills
