Senior Manager Regulatory Affairs (Safety)

Based in Basildon, hybrid working

12 months FTC/Interim

Salary: Competitive + Benefits + Bonus

If you are a strategic Senior Regulatory Affairs and Quality professional capable of implementing and enforcing process improvements in a global operational labelling environment, then we want to hear from you! This role is offered on an interim 12 months fixed term contract basis.

Join us to help improve peoples’ lives and make healthcare better for everyone!

Why Pharmanovia?

Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines.

Our core behaviours are:

• We act decisively but we never compromise on quality.
• We keep our promises and do as we say.
• We value our heritage and foster an entrepreneurial spirit.
• We reinvest in our future – in our products, our brands and our people.
• We give back to our communities.

Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 300 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, U.A.E., India, Singapore, Italy, Spain and South Korea.

We are an agile, committed, and innovative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce. Pharmanovia’s therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology.

About the role:

You’ll be a key member of our regulatory team. Our regulatory department is responsible for providing regulatory strategic advice, support and life cycle maintenance for our portfolio, globally. You’ll apply your expert labelling knowledge, industry experience and business needs to provide strategic input to stakeholders in Regulatory Affairs, Artwork, and Commercial for the creation and execution of all labelling packaging and launch plans for new products.

Your main responsibilities will include:

• Leading the development of the Company Core Datasheet (CCDSs) for new acquisitions or product line extensions with product lead and partners.
• Providing oversight for the review of RMPs, PSURs, CCDSs and portfolio wide changes impacting the prescribing information.
• Providing strategic and operational regulatory labelling input
• Establishing and work within a framework of internal procedures and working practices in support of continuous improvement and compliance with regulatory requirements.
• Implementing and enforcing process improvements to increase the efficiency and effectiveness of the label review process and related workflow
• Interface with key safety and governance stakeholders and partners
• Reviewing of prescribing and patient information for EU, US, Canada, Australia and support key emerging markets
• Overseeing the authoring of documentation to support Labelling Committee
• Overseeing the global and country/regional product information (PI) maintenance, to ensure implementation of the CCDSs into local prescribing/patient information
• Overseeing the management and maintenance of Global Labelling Information in appropriate systems and eDMS
• Monitoring labelling compliance across multiple markets, coordinates the review of the CCDS and subsequent safety updates globally.
• Ensuring diligent reporting and progress updates
• Maintain expertise regarding key labelling requirements worldwide and stay current with labelling guidelines and regulations as they pertain to the development/maintenance of labelling and advise key stakeholders on the application of these labelling principles
• Managing quality control over entire labelling process and management of revisions, including assigning/tracking projects, workflow execution, and issue resolution
• Providing project management to the Labelling Team throughout the entire process, from the decision to update a CCDS/SmPC through notification to stakeholders, to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements
• Oversight and management of national compendia and other public domains where relevant
• Management of patient reminder cards and all other healthcare professional communication where MAH has the responsibility to disseminate communications
• Reviewing and assess local country labels to identify deviation from core labelling and propose cross-functional assessment
• Reviewing and assess competitor labelling for marketed product within the same pharmacological class to support development of new labels such as relating to new indications, to help guide the team in developing labelling text, including contingency strategy development for negotiation with regulatory authorities

About you:

• Proven experience in regulatory affairs
• Extensive knowledge of pharma labelling regulations and requirements
• Strong educational background, ideally a Bachelor’s degree in a scientific/health field
• Ability to review regulatory labelling documents for accuracy and regulatory compliance
• Experience in CCDS and SmPC updates, labelling processes and artwork approval
• Strong knowledge of EU regulatory framework and guidelines.
• Expertise in regulatory submission structure and content (e.g. MAA, NDA)
• Experience in compliance and maintaining product life cycle data bases and RIMs systems
• Fluency in another European language would be advantageous

In return:

We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme and hybrid working.

 By applying for this role, your details will be sent to Ortolan People, who are acting as consultants for the hiring company. Ortolan People are engaged to provide recruitment support in processing applications. We will endeavour to respond to all applicants within three working days. Occasionally for roles with a very high volume of applicants, this may not be possible.