Regulatory Affairs Senior Officer

Title:

Regulatory Affairs Senior Officer

Role Summary

To contribute to the regulatory compliance of the pharmaceutical products in accordance with the regulatory requirements as defined in their QMS/PQS, GDP/GMP. The regulatory strategy and the regulatory department is required to be comprehensively designed and managed incorporating GDP/GMP/MDD/MDR/ISO13485 requirements and supported through Quality Risk Management.

The scope of the role includes medicinal products as registered and forecasted to be further developed in global regulatory environments.

To ensure that their manufactured products demonstrate GDP/GMP compliance, are of appropriate quality, performance and safe for use in accordance with the approved marketing authorisation

Key Responsibilities:

• Ensure the regulatory strategy defined for the department is followed
• Participate in product launches and support the business expansion in new territories, regulated and non regulated markets such as US, Canada, Australia
• Shared responsibility for the Regulatory Department Deliverables
• Support the application for New Product License, Post Marketing dossier maintenance and Licence Renewal
• Shared responsibility for regulatory function inspection readiness: dossiers are maintained, regulatory updates are implemented within required timelines and the implementation timelines are communicated, controlled and made visible to all stakeholders, regulatory department SOPs are written and the QMS are effective in the owned areas
• Contribute in designing and writing up of the marketing authorisation dossiers in an eCTD format
• Participate as key stakeholder in new projects where the regulatory function is a key project contributor or a project owner
• Support any tech transfer activities as a regulatory function and in accordance with the allocated tasks as part of the tech transfer plan
• Communicate directly with regulatory agencies as key point of contact for regulatory affairs as and when required
• Maintain own training file up to date, participate in performance reviews are completed follow the objectives are assigned
• Maintain own knowledge and training up to date
• Support the preparation of regulatory submissions for medicinal products, which may include, but are not limited to, new license applications, variations, PSURs, RMPs, responses to questions and renewals.
• Assist in audit preparation activities.
• Assist in performing gap analysis.
• Assist in ensuring product packaging and associated information is updated and maintained in accordance with product licenses, in international territories, including the review of artwork for product packaging and provision of accurate labelling translations.
• Participate in regulatory team meetings and manage assigned tasks/projects and provide regular updates.
• Use and update regulatory information systems for planning, preparing, tracking and storing submissions to regulatory agencies.
• Contribute to routine local process improvements, which have an impact on the working of the Regulatory Affairs function.
• Assist in a range of activities from product development to commercialisation.
• Perform administrative activities within the function.
• Perform other tasks assigned by the line manager.
• Ensure the companies core Quality organization culture is enabled and embedded in the quality systems as well as part of the employee’s behaviour as a whole

Person specification

Including essential skills and IT skills.

• Must have experience minimum 2 years’ experience gained within the following dosage forms: sterile, oral solid/semisolid and liquid, topical and ophtalmic dosage forms
• in  BcS degree in life sciences
• Min 3 years regulatory experience with pharmaceutical regulatory affairs processes
• Attention to detail
• Familiar with eCTD submissions portal
• Clear verbal and written communication skills and the ability to communication with internal and external stakeholders.
• Interpersonal skills, ability to work within a small team.
• High working ethics and due diligence in all activities
• Accountability and ownership
• Conversant with regulatory requirements in EU and regulated territories: US-FDA, Australia-TGA, Canada
• Familiar with eCTD operating software and electronic portals (MHRA and international)
• Familiar with direct communication with regulatory authorities in an international environment