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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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