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Regulatory Affairs Specialist

2 months ago

Harlow, Essex, United Kingdom Teva Pharmaceuticals Full time
{"title": "Regulatory Affairs Associate", "description": "Join Our Team at Teva Pharmaceuticals

We are seeking a highly skilled Regulatory Affairs Associate to support our European Generic new submissions via decentralized and mutual recognition procedures. As a key member of our EU Regulatory Affairs department, you will work closely with cross-functional teams to ensure dossier technical content is optimal and aligned with EU Regulatory data requirements.

Key Responsibilities:

  • Ensure dossier technical content is optimal and aligned with EU Regulatory data requirements for new EU Marketing Authorisation Applications and post-approval variations.
  • Perform regulatory activities for assigned projects from pre-submission until post-approval handover to regulatory maintenance teams.
  • Communicate regulatory information for assigned projects before, during, and after approval.
  • Track and monitor queries/deficiency letters/commitments from/to European Health Authorities.

Requirements:

  • Pharmacy/Chemistry or Life Sciences degree.
  • Regulatory Affairs experience ideally with medicines, medical devices, OTCs.
  • Knowledge of pharmaceutical & scientific processes, regulatory requirements, and internal/external communications skills.

What We Offer:

  • A dynamic and supportive work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.

Apply Now:

If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity.

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