Regulatory Affairs Officer

Zentiva; Guildford; On-site; GBP 30,000 - 60,000

Job description

Regulatory Affairs Office

Zentiva Pharma UK Ltd is a leading manufacturer of generic pharmaceutical products throughout the UK and Europe. We strive to be the champions of Generics and Over The Counter (OTC) medicines to better support people's daily healthcare needs.

• Responsible for the preparation, distribution and control of registration documentation required for regulatory submissions to high standards and within agreed timelines to ensure that marketing authorisations are obtained and maintained in line with the company's requirements.
• Contribute to timely communication of safety information to Regulatory Authorities, Healthcare Professionals and patients.
• Provide input into registration strategies for commercialisation and life cycle management of products both locally and in conjunction with corporate regulatory as required.
• Contributes to ensuring the company provides an uninterrupted supply of product to the market that is in compliance with the marketing authorisation.
• Works proactively with team members of the local and corporate business to ensure project needs are met compliantly within agreed timelines.

MAIN ACCOUNTABILITIES AND DUTIES

• Preparation of marketing authorisation application documentation to the highest possible standards, within the required timeframe, for submission to the regulatory authorities.
• Create and review, as required, local labelling, leaflet and summary of product characteristics documentation, ensuring compliance with current legislation and registered particulars, for submission to the regulatory authorities.
• Ensure all marketing authorisations are updated with new safety information in a timely manner and ensure Company Core Safety Information is incorporated into local labelling according to regulatory and corporate requirements.
• Ensure all the necessary maintenance activities for local marketing authorisations are completed e.g. livery/artwork updates.
• Work collaboratively and proactively with local and corporate contacts to ensure timely submission of regulatory changes.
• Develop a comprehensive understanding of the regulatory environment, including data requirements, relating to marketing authorisations for medicinal products in the UK and Europe and, if required, for non-medicinal products e.g. devices.
• Develop an understanding of the commercial environment in the UK and contribute to the commercial success through ensuring submission priorities are met and contributing to projects as required.
• Input into providing regulatory advice during development, to support life-cycle management and commercial activities. Inform line management and relevant colleagues of deviations from regulatory schedules which may affect marketing plans.
• Carry out any necessary administrative activities to ensure the effective and compliant operation of the regulatory department such as:
  • maintaining department systems
  • updating corporate databases
  • creating and maintaining SOP's
• Develop relationships with other company functions at local and corporate level to ensure cross-functional working.
• Develop professional relationships with regulatory agencies and other external contacts as necessary.
• Escalates any decisions, or seek the support of colleagues or management if personal knowledge and understanding is not at the level required to carry out any part of the role.

OTHER RESPONSIBILITIES

QUALITY

• Adheres to the principles of GxP in the extent related to the performed activity. Is obliged to regularly train in this policy.

HSE

• Adheres to the principles communicated within the Environment and Safety Management System (ESMS) Policy of Zentiva detailed in the internal rules of the Company for the purpose of observing the rules of the Health & Safety at Work and the Environmental & Safety Management System.

PHARMACOVIGILANCE

• All employees are obliged to report any suspicion of adverse events of medicinal products, any adverse events concerning use of a medical device and any other safety information about medicinal products or medical devices in line with relevant internal regulations.

COMPLIANCE

• The employee will comply with all internal rules and policies of the Company. The employee will make themselves acquainted with the Code of Ethics and will comply with the principles stated therein and in all related policies and other internal documents.

KEY WORKING RELATIONSHIPS

INTERNAL

• Work cross functionally with internal teams including:
  • UK Commercial team
  • UK Supply Chain
  • UK Medical Affairs
  • UK Pharmacovigilance
  • UK Quality

• Work collaboratively with:
  • Global Regulatory Affairs
  • Artwork teams
  • Supply planners
  • Manufacturing and packaging sites

Occasional contact with:

• IS
• Other company sites e.g. affiliate offices

EXTERNAL

• Grow and maintain strong relationships with:
  • MHRA

Occasional contact with:

• Trade associations.

REQUIRED QUALIFICATIONS, EXPERIENCE AND SKILLS

• A degree or professional qualification in science, preferably a life science, or some experience in Regulatory Affairs. Additional experience in the pharmaceutical industry or a related field would be an advantage.
• Familiar with the pharmaceutical research and development process, and capable of critically reviewing and integrating scientific information from a variety of disciplines.
• Administratively well-organised, have attention to detail, possess strong written and oral communication skills and be able to manage multiple priorities.
• Self-motivated and able to demonstrate cross-functional collaborative working.
• Training in regulatory requirements, both externally through courses and meetings, and internally, to maintain an understanding of current regulatory requirements and issues will be provided.