Senior Regulatory Affairs Officer

Senior Regulatory Affairs Officer

Job description

At STADA we pursue our purpose Caring for people s health as a trusted partner worldwide. Originally founded by pharmacists, we are a leading manufacturer of high-quality pharmaceuticals.

More than 12,300 employees around the globe live our values Integrity, Entrepreneurship, Agility and One STADA to achieve ambitious goals and shape the successful future of STADA.

Senior Regulatory Affairs Officer

Reading United Kingdom (GB) Full-time Permanent

OBJECTIVE

To prepare and submit right-first-time new MAs and life cycle management of product licences including but not limited to variations in line with the agreed strategy.







To ensure the product licences in the registered markets are in compliance with Regulatory requirements and manufacturing sites practice

KEY ACCOUNTABILITIES

- Compile and submit variations (DCP / MRP / National) in line with the variation regulations, SOPs (where relevant) and national Competent Authority requirements
- Compile and submit renewals (where relevant) prior to MA expiry in line with the variation regulation, company SOPs (where relevant) and national Competent Authority requirements
- Lead Regulatory approval processes for licence maintenance and MA submissions in new markets
- Liaise with Regulatory Authorities to agree submission strategies and resolve issues
- Ensure submissions are made in agreed timeframe and in line with current health authority regulations to support department schedules / priorities for launch and maintenance
- Update relevant functional stakeholders of any delays and / or schedule conflicts in fulfilling regulatory plans
- Build relationships with key stakeholders and represent the business in a responsible manner according to company values,





in order to communicate policies and strategies and negotiate outcomes
- Analyse Regulatory issues, propose and agree solutions with the manager and communicate effectively with key stakeholders, including local, regional and partner colleagues
- Analyse Regulatory risks, propose and agree mitigation plans with the manager and communicate effectively to the business
- Manage compliance within defined portfolio / activity streams in line with business expectations
- Develop effective ways of working with other functions (e.g. quality, marketing, supply chain) to deliver agreed objectives
- Provide Britannia QPs, QA team and CMOs with current licence information
- Raise Change Controls for regulatory activities within the department






- Create and maintain SOPs and Work Instructions for the Regulatory function
- Support internal / external inspections and audits
- Ensure that specifications and labelling are appropriately controlled
- Ensure Regulatory documentation is appropriately archived
- Submit Notification of Intention to Import’ Unlicensed Relevant Medicinal Products applications
- Maintain MIA, WDA and API Registration licences
- Support partners to obtain GMP accreditation of contract manufacturing sites, where appropriate
- Prepare Regulatory metrics associated with the regulatory systems and take appropriate action where and when required
- Support on-site audits by customers and health authority
- Ensure that incidents,





deviations and other quality system requirements related to the regulatory department are captured, reported and fully investigated and root cause established has context menu.
- Support self-inspection of regulatory department as SME and agree CAPA
- Raise CAPA and Change Controls as required for regulatory related activities
- Support artwork of a medicinal products to ensure it is accurate, complete, and compliant with the Regulatory requirements.
- Compose and review regulatory affairs SOP
- Perform relevant training within the business
- Supporting complex supplier requests
- Provision of information for Product Quality Reviews
- Continuous improvement of Regulatory department
- Deputise for Senior Regulatory Affairs Manager and chair meetings as required
- Supporting cross functional projects







PERSONAL SPECIFICATION (Skills required to perform the job)

- Life science degree or equivalent
- Relevant experience within Regulatory Affairs
- Experience in handling regulatory submissions to global authorities both new application and life-cycle management
- Experience in negotiating and agreeing positive submissions outcome with the Health Authorities
- Ability to effectively communicate and negotiate in relation to technical information and regulations
- Excellent oral and written communication skills, able to be effective at all levels including communication with EU affiliates and EU regulatory agencies
- Ability to assess problems and propose appropriate solutions and Excellent decision-making
- Knowledge of the EU and Global Regulatory requirements






- Experience in dealing with multiple partners and affiliates
- Excellent attention to detail
- Ability to build effective networks both internally and externally
- Must be organised, efficient, and a good team player
- Must be able to commute to the office 3x per week (Monday, Tuesday and Thursday)

We are looking for talents with expert knowledge and an entrepreneurial spirit that enjoy working collaboratively in a global team.

We are pleased to get to know you better.