Regulatory Affairs Officer

To prepare and submit right-first-time new MAs and product maintenance 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.,

• 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. marketing, supply chain) to deliver agreed objectives


• Provide Britannia QPs 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


Compliance

• Is responsible for working in accordance with our compliance procedures, legislation and regulatory requirements at all times. This includes, but not limited to, directives and guidance such as PMCPA, NMC, APBI Code of Practice, GMDP and other GxPs
  
  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


• Ability to assess problems and propose appropriate solutions


• 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
  
  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.

Britannia Pharmaceuticals, part of the STADA Arzneimittel AG group of companies, is a UK based pharmaceutical company specialising in the neurology market. Britannia focuses on innovative products for chronic and serious medical conditions, and in particular, the treatment of Parkinson's disease. We are highly committed to improving the quality of life for People with Parkinson's disease., Are you looking for new challenges where you can make a difference for people's health? We are looking for candidates with positive attitude, expert knowledge and an entrepreneurial spirit that enjoy friendly working environment in a global team. We would be pleased to get to know you. Please use our online job portal to submit your application: https://jobs.stada.com