Regulatory Affairs Officer

6 months ago

Reading, United Kingdom STADA Arzneimittel AG Full time

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.**Regulatory Affairs Officer**
- Reading | United Kingdom (GB) | Full-time | Permanent**Objective**
- 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.**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. 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
- 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

**Personal Specification**
- Life science degree or equivalent
- Relevant experience within Regulatory Affairs
- 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

  • Regulatory Affairs Specialist

    3 weeks ago

    Reading, Reading, United Kingdom Actalent Full time

    Regulatory Affairs Manager Role OverviewAt Actalent, we are seeking an experienced Regulatory Affairs Manager to join our dynamic and innovative pharmaceutical company. As a Regulatory Affairs Manager, you will be responsible for providing expert regulatory guidance to our UK organization and managing all regulatory activities across the UK and Ireland.Key...

  • Regulatory Affairs Manager

    4 weeks ago

    Reading, United Kingdom Actalent Full time

    Job Description Regulatory Affairs Manager - Pharmaceuticals As the Regulatory Affairs Manager for the UK and Ireland, you will report directly to the UK Country Manager. You will provide expert regulatory guidance to our UK organization and manage all regulatory activities across the UK and Ireland. Additionally, you will serve as the Local Person for...

  • Regulatory Affairs Manager

    1 month ago

    Reading, United Kingdom Actalent Full time

    Regulatory Affairs Manager - Pharmaceuticals As the Regulatory Affairs Manager for the UK and Ireland, you will report directly to the UK Country Manager. You will provide expert regulatory guidance to our UK organization and manage all regulatory activities across the UK and Ireland. Additionally, you will serve as the Local Person for Pharmacovigilance...

  • Regulatory Affairs Manager

    1 month ago

    Reading, United Kingdom Actalent Full time

    Regulatory Affairs Manager - Pharmaceuticals As the Regulatory Affairs Manager for the UK and Ireland, you will report directly to the UK Country Manager. You will provide expert regulatory guidance to our UK organization and manage all regulatory activities across the UK and Ireland. Additionally, you will serve as the Local Person for Pharmacovigilance...

  • Regulatory Affairs Manager

    1 month ago

    Reading, United Kingdom Actalent Full time

    Regulatory Affairs Manager - Pharmaceuticals As the Regulatory Affairs Manager for the UK and Ireland, you will report directly to the UK Country Manager. You will provide expert regulatory guidance to our UK organization and manage all regulatory activities across the UK and Ireland. Additionally, you will serve as the Local Person for Pharmacovigilance...

  • Regulatory Affairs Manager

    7 days ago

    Reading, United Kingdom Cranleigh Stem, Sustainability & Sheq Recruitment Full time

    The Role This newly established global position is critical to ensuring compliance with all relevant regulations related to the production, distribution, and marketing of our clients' veterinary diagnostic products.As the Regulatory Affairs Manager, you will play a key role in shaping and implementing a regulatory strategy that aligns with our business goals...

  • Regulatory Affairs Manager

    6 days ago

    Reading, United Kingdom Cranleigh Stem, Sustainability & Sheqrecruitment Full time

    The Role This newly established global position is critical to ensuring compliance with all relevant regulations related to the production, distribution, and marketing of our clients' veterinary diagnostic products.As the Regulatory Affairs Manager, you will play a key role in shaping and implementing a regulatory strategy that aligns with our business goals...

  • Regulatory Affairs Specialist

    3 weeks ago

    Reading, United Kingdom Actalent Full time

    Regulatory Affairs Manager - PharmaceuticalsAs a key member of our UK team, you will provide expert regulatory guidance and manage all regulatory activities across the UK and Ireland. Your responsibilities will include serving as the Local Person for Pharmacovigilance (LPPV) and the National Pharmacovigilance Contact Person.We are a dynamic and innovative...

  • Regulatory Affairs Manager

    1 week ago

    Reading, United Kingdom Cranleigh STEM, Sustainability & SHEQ Recruitment Full time

    The RoleThis newly established global position is critical to ensuring compliance with all relevant regulations related to the production, distribution, and marketing of our clients’ veterinary diagnostic products. As the Regulatory Affairs Manager, you will play a key role in shaping and implementing a regulatory strategy that aligns with our business...

  • Regulatory Affairs Manager

    4 days ago

    Reading, United Kingdom Cranleigh STEM, Sustainability & SHEQ Recruitment Full time

    The RoleThis newly established global position is critical to ensuring compliance with all relevant regulations related to the production, distribution, and marketing of our clients’ veterinary diagnostic products. As the Regulatory Affairs Manager, you will play a key role in shaping and implementing a regulatory strategy that aligns with our business...

  • Regulatory Affairs Manager

    1 month ago

    Reading, UK, Berkshire, United Kingdom Actalent Full time

    Regulatory Affairs Manager - Pharmaceuticals As the Regulatory Affairs Manager for the UK and Ireland, you will report directly to the UK Country Manager. You will provide expert regulatory guidance to our UK organization and manage all regulatory activities across the UK and Ireland. Additionally, you will serve as the Local Person for Pharmacovigilance...

  • Regulatory Affairs Project Manager

    2 days ago

    Reading, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job Description Job title: Regulatory Affairs Project Manager – UK/IE A Top 10 Pharmaceutical business in Berkshire are seeking a Regulatory Affairs Project Manager.This is a UK/IE affiliate role and will work across an Oncology portfolio.Responsibilities: Serves as Health Authority liaison and interfaces with Health Authorities.Lifecycle management of...

  • Regulatory Affairs Manager

    2 days ago

    Reading, United Kingdom CV-Library Full time

    The RoleThis newly established global position is critical to ensuring compliance with all relevant regulations related to the production, distribution, and marketing of our clients’ veterinary diagnostic products. As the Regulatory Affairs Manager, you will play a key role in shaping and implementing a regulatory strategy that aligns with our business...

  • Regulatory Affairs Manager

    1 week ago

    Reading, UK, Berkshire, United Kingdom Cranleigh STEM, Sustainability & SHEQ Recruitment Full time

    The RoleThis newly established global position is critical to ensuring compliance with all relevant regulations related to the production, distribution, and marketing of our clients’ veterinary diagnostic products. As the Regulatory Affairs Manager, you will play a key role in shaping and implementing a regulatory strategy that aligns with our business...

  • Regulatory Affairs Project Manager

    4 days ago

    Reading, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job DescriptionJob title: Regulatory Affairs Project Manager – UK/IEA Top 10 Pharmaceutical business in Berkshire are seeking a Regulatory Affairs Project Manager. This is a UK/IE affiliate role and will work across an Oncology portfolio. Responsibilities:Serves as Health Authority liaison and interfaces with Health Authorities. Lifecycle management of...

  • Regulatory Affairs Manager

    2 days ago

    Reading, United Kingdom Cranleigh Stem, Sustainability & Sheq Recruitment Full time

    Job Description The Role This newly established global position is critical to ensuring compliance with all relevant regulations related to the production, distribution, and marketing of our clients' veterinary diagnostic products.As the Regulatory Affairs Manager, you will play a key role in shaping and implementing a regulatory strategy that aligns with...

  • Regulatory Affairs Expert for Pharmaceutical Compliance

    3 weeks ago

    Reading, Reading, United Kingdom Actalent Full time

    Actalent is seeking a highly skilled Regulatory Affairs Manager to provide expert guidance to our UK organization and manage regulatory activities across the UK and Ireland.Job SummaryThis role involves providing regulatory expertise to the organization, managing regulatory activities for the UK and Ireland, ensuring compliance with UK regulatory processes...

  • Regulatory Affairs Project Manager

    5 days ago

    Reading, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job title: Regulatory Affairs Project Manager – UK/IE A Top 10 Pharmaceutical business in Berkshire are seeking a Regulatory Affairs Project Manager. This is a UK/IE affiliate role and will work across an Oncology portfolio. Responsibilities: Serves as Health Authority liaison and interfaces with Health Authorities. Lifecycle management of...

  • Global Regulatory Affairs Manager

    1 month ago

    Reading, Reading, United Kingdom Bayer AG Full time

    Regulatory Affairs Policy RoleThe Senior Manager Inclusion Health Policy role plays a critical part in ensuring the company can effectively navigate and shape the external regulatory landscape to better enable self-care across the diverse portfolio that spans OTC medicines, medical devices, cosmetics, and food supplements.Key ResponsibilitiesLead, develop,...

  • Regulatory Affairs Policy Strategist

    3 weeks ago

    Reading, Berkshire, United Kingdom myGwork Full time

    This job is with Bayer UK & Ireland, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for...