Regulatory Affairs Specialist
Location : Philadelphia PA US 19154
Job Type : Direct
Reference Code : 19456-AB1
Compensation : 65000.00 - 80000.00 USD/YEAR
Hours : Full Time
Required Years of Experience : 3
Required Education : BS Life Science
Travel : No
Relocation : No
Job Industry : Pharmaceutical
Job Description :
- Permanent position for a Regulatory Specialist responsible for regulatory submissions and for post-approval maintenance of regulatory documentation.
- Interface with other departments and regulatory agencies regarding regulatory submissions and regulatory affairs.
- Prepare and file high-quality regulatory submissions to USFDA, EMEA, MHRA and other global regulatory agencies.
- Provide regulatory guidance to other departments.
- Represent Regulatory Affairs on project teams.
- Review technical documents for cGMP and regulatory compliance.
- Train new regulatory specialists.
Required Qualifications :
- Bachelors in Life Science, MS or PhD a plus.
- Minimum 3 years experience in pharmacuetical industry regulatory submissions.
- Experience with filing INDs, 505 (b)(2), Master Files, drug product applications with USFDA, EMEA, MHRA regulatory agencies.
Contact: Allan Berman
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