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Compliance Officer

2 months ago

London Area, United Kingdom SUN PHARMA Full time

Job Summary:

Sun Pharma is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring the compliance of our pharmaceutical and medical products with regulatory requirements in the UK market.

Key Responsibilities:

  • Liaise with internal and external stakeholders to ensure timely receipt of necessary documents, including those from R&D, RA, and artwork departments, as well as translations services and consultants.
  • Prepare and verify SmPC, labelling, and PILs texts according to the Quality Review of Documents (QRD) format.
  • Verify the technical content of product information documents to ensure accuracy and compliance.
  • Review and approve artwork for packaging materials to ensure regulatory compliance.
  • Ensure that dossier technical content is optimal and aligned with UK Regulatory data requirements for new UK Marketing Authorisation Applications.
  • Manage the life cycle of dossiers and approved marketing authorizations by submitting variations, notifications, PSURs, and renewals as required.
  • Collaborate with regulatory colleagues in country offices, corporate groups, and competent authorities (MHRA) on regulatory issues.
  • Work closely with internal customers, including Research & Development, Artwork, Pharmacovigilance, Quality Assurance, Logistics, Finance, Business Development, and Sales.
  • Maintain RA archives electronically and ensure that regulatory information is accurate and accessible to stakeholders.
  • Work with required IT standards, such as eCTD and XEVMPD, and corporate IT systems like AMS, Trackwise, eDMS, eLMS, and OneHR.
  • Develop and write standard operating procedures to ensure compliance and efficiency.

Requirements:

  • Bachelor or Master's Degree in Life Sciences, Languages, or Law.
  • Comprehensive knowledge of the UK and EU Regulatory Framework, including directives, regulations, and guidelines.
  • Understanding of the drug development process.
  • Able to comply with company standard operating procedures.
  • Excellent verbal and written communication skills in English.
  • Proficiency in Microsoft Office packages and specific packages/portals, such as eCTD software, XEVMPD software, TVT, CESP, EMA gateway, MHRA, and CBG portal.
  • Attention to detail, time management, organization, and project management skills.
  • Interpersonal and team working skills, with experience in delivering training and presentations.