Pharmaceutical Affairs Manager - UK

About Almirall

We care. Through pharmaceutical innovation and a strong commitment to global healthcare partnerships, we are committed to providing tools, knowledge and science to improve the health of patients worldwide. We research, develop, manufacture and commercialize our own medicines as well as a portfolio of licensed products tailored to the needs of different therapeutic areas. Today, our products are available in over 70 countries on 5 continents through 15 subsidiaries.

Almirall is an international biopharmaceutical company based in Barcelona. Our strategic focus is on skin health. In order to achieve our corporate goal "Transform the patients' world by helping them realize their hopes & dreams for a healthy life.", we as a team give our best every day. Because our mission is to improve the quality of life of skin patients, understand their needs and use science to provide innovative medical solutions. The patient is always at the centre of everything we do. To fulfil our mission, we are continuously expanding our portfolio and focusing on promising innovations, particularly in the field of biologics.

Our Culture

At Almirall, our Noble Purpose is at the core of our work: “Transform the patients' world by helping them realize their hopes and dreams for a healthy life”. We invest in differentiated and ground-breaking medical dermatology products to bring our innovative solutions to patients in need. We listen to the patient and physician responding to their needs and helping them get the treatments they need. We are driven by science, diligent by nature. 

We have a successful history in Dermatology space which places us well to create a strong footprint into specialty immuno-dermatology.

You can find more information about Almirall through this link: : EEVP Almirall (publicaciones-digitales.cVP Almirall (publicaciones-digitales.com)

Position Summary/Mission

The Local Pharmaceutical Affairs Manager is responsible for planning and managing all regulatory activity associated with the UK and Ireland product portfolio in collaboration with Corporate Regulatory Affairs and other related corporate functions, Also as the registered Responsible Person and Responsible Person (import), collaborates with Corporate Quality Assurance and maintains the Quality System in the UK and Ireland to ensure Good Distribution Practice for products marketed by Almirall Limited. Acts as deputy to Local Safety Officer (LSO) to support good pharmacovigilance practices.

Core Responsibilities

1. Act as the primary regulatory resource to the business and work collaboratively with the UK Medical team, Brand and Sales teams

• Provision of regulatory strategy and guidance to Almirall UK medical, clinical, commercial and sales departments
• Provide regulatory support to Product Core Teams, as required
• Provide monthly reports to Medical Director and to provide Senior Regulatory input to UK senior management team as required
• Ensure that all Marketing Authorisations for Almirall products within the UK and Ireland are appropriately maintained to support commercial activities
• Form and maintain an effective working partnership with sales and marketing to deliver the highest quality input and enable accuracy and compliance when needed
• Provide training to internal and external stakeholders as appropriate
• Provide regular reports to Pharmaceutical Affairs Director and provide regulatory input to UK senior management team, if required
• Keep Medical team informed about any planned, on-going or approved change in Product Information
• Provide support in the preparation of hospital public tenders, if required
• Provide support in answering questions received from physicians, pharmacists or patients.

2. Lead on the submission of all regulatory submission documentation to the authorities and as the key contact for the MHRA and HPRA

• Provide regulatory strategy on behalf of Almirall leading to timely regulatory submissions and approvals in the UK and Ireland, as appropriate
• Manage the submission strategy and the preparation of high-quality documentation for all regulatory submissions, following current practice standards
• Proactively seek expert input as required into regulatory documents
• Gain approval for new Clinical Trial Authorisations (CTAs) and maintain existing CTAs to support Almirall sponsored clinical trials in UK, as appropriate
• Manage contact with local Competent Authorities in UK and Ireland and advise business on registration/licencing requirements for Medical Devices in UK and Ireland
• Represent Almirall at formal meetings and hearings with the UKa nd Irish Regulatory Authorities

3. Own the maintenance of Almirall product registration, label and license

• Maintain existing regulatory approvals in UK and Ireland, in support of Almirall's commercial activities and strategy (e.g. submission of renewals, variations)
• Communicate with the UK and Irish Regulatory Authorities to discuss and resolve technical matters relating to national Marketing Authorisation (MA) applications (variations and new applications) as required
• Be responsible for the information held within the Corporate Regulatory databases for the UK and Ireland products, and for maintaining the physical files, if required
• Be responsible for the information of changes on Product Information in internal and external official websites
• Be responsible for the request, review and approval of changes in packaging materials and for tracking its implementation in packs.

4. Work with Regulatory Affairs centrally ensuring local alignment

• Liaise with corporate Regualtory Affairs and other corporate departments to provide input/advice on international regulatory strategies, submissions and activities
• Provide local regulatory intelligence for the maintenance of all MAs compliant with local legislation.

Core Responsibilities (cont'd)

5. Works closely with Corporate Quality Assurance to maintain GDP

• Is the named Responsible Person (as listed on Wholesale Distribution Authorisation (human use))
• Is the names Responsible Person (import)  (as listed on Wholesale Distribution Authorisation (human use))
• Be named contact on WDA (h)
• Updates WDA(h) when needed
• Implements and manages the Quality system documentation including Quality Manual and SOPs
• Ensures Good Distribution Practice (GDP) training, its continued implementation and maintenance
• Ensures Responsible Person (import) checks are performed on each imported batch of medicinal products and medical devices prior to release to market
• Co-ordinates and promptly performs any recalls
• Performs in the absence of a recall, one mock recall each year
• Ensures Product Quality Complaints are processed and dealt with effectively
• Ensures customers and suppliers are approved
• Approves any returns to saleable stock
• Conducts an audit (self -inspection) together with Corporate Qiuality Assurance of the activities relating to GDP at least once per year and follow-up of any corrective actions
• Ensures that the distribution site is audited at least once a year and follow-up on any corrective actions as required
• Performs periodic Quality Management Reviews at least twice per year.

6. Supports the Local Safety Officer (LSO) as Deputy

• Be the main contact for Pharmacovigilance in the absence of the LSO
• Performs LSO duties, as required
• Maintains a good working knowledge of Pharmacovililance legislation and regutations.

In relation to the above responsibilities, ensures Almirall Ltd is audit-ready at all times through the development, ongoing management of, and adherence to, regulatroy and corporate quality assurance policies and processes for the UK and Ireland.

Required Education and Experience

• Life Science, Cemistry or Pharmacy degree
• Minimum five years Regulatory Affairs experience
• Thorough regulatory experience and knowledge of regulatory procedures and systems in the UK and EU (including GCP, GPvP, GMP, GLP and GDP)
• Excellent understanding on matters related to promotional compliance
• Experience in audits (internal and external) is an advantage
• Strategic understanding of drug development principles and processes
• Proficient IT skills, with knowledge or an ability to learn software applications such as document management systems,  databases and spreadsheets
• Awareness of health systems and commercial environments.

Skills

• Able to work closely with internal and external stakeholders and follow up on commitments and requests
• Ability to work effectively, proactively with appropriate levels of supervision
• Good analytical skills and high commercial awareness
• Excellent interpersonal skills