Regulatory Affairs Manager

An exciting opportunity for an experienced Regulatory Affairs Manager to join a growing generic pharmaceutical company targeting a portfolio of 220 licenses.

++ Please note: This is a 5-day-per-week onsite role ++

Key Responsibilities

• Primarily responsible for post-approval and compliance activities, with a supporting role in pre-approval processes.
• Key focus areas:
  • Handling Variations (Type IA, IB, II, labelling changes, own-label supplies, safety updates, and line extensions).
  • Reclassification of Medicines.
  • Management of Re-baseline / Remediation dossiers.
  • Conducting License Transfers (including due diligence of dossiers).
  • Maintenance of Marketing Authorisations (including renewals).
  • Responding to deficiencies from regulatory authorities.
  • Interfacing with regulatory authorities to ensure smooth approval of submissions.
  • Working with sites (manufacturing, PV service provider) and stakeholders to meet regulatory requirements and resolve issues.
  • Serving as the primary Regulatory Affairs contact for business units, customers, and internal/external teams.
  • Keeping abreast of new and changing regulatory requirements to ensure compliance.
  • Collaborating with the QPPV on PSUR submissions and maintaining alignment with SmPC and labelling standards.
  • Liaising with authorities for regulatory advice and guidance to resolve issues effectively.
  • Maintaining accurate records and documentation related to Marketing Authorisations.
  • Aligning activities with regulatory, commercial, quality, and business needs while ensuring compliance with legislation, guidelines, and company policies.
  • Providing support to other Regulatory Affairs staff as necessary.
  • Assisting in procedure (SOP) preparation for relevant regulatory activities.
  • Completing any additional tasks assigned by stakeholders to fulfil role requirements.