At AstraZeneca, we are united by a common purpose – to push the boundaries of science to deliver life-changing medicines. This purpose underpins everything we do; our work helps to make hearts healthier, to help people breathe easier, and to help more people survive cancer. Every single day, we make a difference by delivering potentially life-changing medicines to millions of people worldwide and by leading breakthrough science that promises to transform the treatment of disease. Could be you that person?

As a Regulatory Affairs Manager, you will be into the Medical Department, reporting directly to the Regulatory Affairs Lead. Your mission will be to implement the strategy of registration of new products, existing ones and those in clinical development phases, carrying out the necessary follow-up and ensuring that the information related to these products aligns with the quality, efficacy and safety requirements approved by health authorities. Ensure that the Local Regulatory Strategy is in line with the AEMPS Strategic Plan and its annual work plans.

Responsibilities

1. Team Management and Development (these responsibilities only apply when regulatory Affairs Manger is assigned)

• Establish the team's vision and mission, to ensure alignment in AZ's strategy, objectives and values.
• Ensure the accurate training of the team of specialists, participating in their training plan.
• Support the development of the team, focusing on the consolidation of its strengths and the enhancement of its areas of improvement, favoring an adequate motivation and climate.
• Participate in performance improvement, handling available tools (performance assessment, improvement feedback, mentorship, training identification, talent management, etc.).

2. Planning

• Provide a global vision, as well as the analysis of scenarios from a planning point of view for the registration of products in development, line extensions and in the product lifecycle, at international and local meetings.
• Participate in local and international meetings for the development of new products and pre-registration activities related to this Area.
• Be part of the Brand Team by providing information about registration documentation, regulatory status of competitors based on the information available on the websites of regulatory agencies, regulations and legislative environment.
• Provide the necessary information of your area of responsibility in the meetings of the "Operational Supply Planning" (SO&P), for the fulfillment of the conditions of authorization of the products in the market, the preparation and planning of new launches (products, indications or others), transfers of ownership, cancellations and temporary suspensions of marketing authorisations.

3. Regulatory

• Supervise regulatory applications for new indications, dosage guidelines, line extensions, ensuring that current legislation, Health Authority guidelines and established deadlines are met, following company standards.
• Manage the accurate maintenance of commercialising authorisations for all products (revalidation, annual commercial intention, quality variations, efficiency and safety, data sheets, labelling, leaflets, compliance with new national and/or EU regulations).
• Controlling activities related to transfers of ownership, temporary suspensions of commercialising or cancellation of marketing authorisations.
• Coordinate with the Technical Direction all changes to marketing authorizations that affect: manufacturers, specifications, labeling, leaflet and approvals of new registrations, cancellations and transfers of our medicines.
• Supervise, where applicable, registration activities with Licensors or third parties, ensuring that they are conducted in accordance with applicable laws and regulations.
• Supervise the management of the conditioning material and approve such material following the internal procedure of the company.
• Advise, Ad hoc, Comunicación and Nominated Signatory, among other functions, in relation to institutional materials, press releases etc., with respect to the applicable regulatory legislation and regulations, as well as in relation to the approved data sheet and, where applicable, commitments acquired by the company.
• Collaborate with the Head office, providing the necessary information to track the budget associated with the Regulatory Area under its responsibility.
• Keep global databases on legislation and registration regulations, both national and European, up-to-date by providing the necessary regulatory information in audits.
• Lead, monitor and track special projects related to optimizing the development of activities carried out in the Regulatory Area (AZIR, Global Labelling, ANGEL, etc.).
• Promptly report all regulatory activity to the different areas of the Company, as appropriate.
• Support the company's Customer Service, leading or redirecting Pharmacovigilance/Technical Management/Medical Information or others, as appropriate, inquiries about the company's products.

4. Clinical Trials

• Lead Clinical Trials applications to AEMPS, from updating and monitoring to authorizing them, making the necessary amendments or modifications where necessary in coordination with Clinical Research and Pharmacovigilance.

5. Compliance

• Ensure that all activities related to your workplace comply with applicable external and internal regulations (policies, procedures, standards, guidelines and code of conduct).
• Carry out the activities required for the accurate compliance of the Quality Management System (QMS) in the GRP and GMP/GDP area, as defined in the applicable standard, in collaboration with the GRP/GMP/GDP Quality Lead.

Requirements

Essential

• Training: Bachelor's degree/Degree in Health Sciences
• Both English and Spanish: C1 or equivalent.
• Computing: Office advanced level.
• 5 years experience in the pharmaceutical industry with ethical products having held at least one of these positions:

Similar position in another company: at least 2 years.

Regulatory Affairs Specialist: at least 5 years.

• Having led or actively participated in project and team management.
• In-depth knowledge of legislation and the pharmaceutical environment.
• Previous experience in the Oncology area.

Desirable

• Knowledge to make a critical discussion of the efficacy and clinical safety sections of the evaluation reports generated during the drug registration procedure, the Therapeutic Positioning Reports (IPTs) and other regulatory documents.
• Previous experience in the management of clinical trial applications with the Spanish Agency for Medicines and Healthcare Products (AEMPS), as well as its amendments and subsequent notifications.
• Leadership or active participation in working groups or regulatory projects at the global level.

Functional Relations

Internal

• Physician: Technical Direction / Medical Lead / Medical Manager / MSLs / Clinical Research / Pharmacovigilance / No Signatory.
• Marketing: MK Lead / Product Manager.
• Access: Market Access Lead / Market Access Manager/ Pricing Lead / RHAM / RMAM.
• Legal: Legal Director.
• Compliance.
• Finance: Supply / Administration.
• Operations: Distribution.
• Customer Service.

External

• Health authorities (regulators, evaluators and inspectors): AEMPS and CAM.
• Ministry of Health and Consumer Affairs / Ministry of Industry.
• Professional and employers' associations, AEFI, FI.
• Meaningful clinical research figures, clinical pharmacologists and other scientific specialists.

Competences

• Scientific Leadership.
• Leadership and Team Development and Own Development.
• Medical Excellence.
• Business knowledge.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.