Senior Director, Regulatory Affairs Eu

hace 5 meses

Barcelona, España AstraZeneca A tiempo completo

This role is the key account manager for the regulatory EU Marketing Company (EUMC) thereby managing and coordinating all EU regulatory affairs CP-related matters in close collaboration with local EU Marketing Company Regulatory Affairs (MCRA) Heads, EU marketing company presidents and all relevant Global Functions.

**Internal Focus**:

- Responsible for EUMC legal accountabilities are met.
- Leads the EU Regulatory Coordination Team (EU RCoT)
- Works with local EU MCRA Heads and Global Functions to define, support and deliver the overall EU regulatory strategy and workplan with appropriate resourcing at local level.
- Ensures EU specific regulatory legislation are fully embedded in the overall AZ organization.
- Is the main link into the global regulatory Therapeutic Area (TA) organizations ensuring aligned ways of working and consistent and timely communication from and towards EU MCRA is delivered for centralized registered products.
- Ensures that the regulatory operating model and toolkits address EU MCRA needs.
- Is member of the TA Executive Directors Network.
- Provides the MC regulatory input into EU issue management resolution.
- Promote, contributes, facilitates, and occasionally leads innovative strategies to partner with the relevant EU regulatory authorities to optimize the predictability of the regulatory outcome and to provide the regulatory platform for optimizing and maintaining market access in the allocated Markets driving launch excellence.
- Partners and collaborates effectively with key internal stakeholders outside regulatory such as EU and TA Commercial, EU Marketing Companies, EU Medical and Market Access to ensure launch excellence.
- Ensures the global regulatory organization provides an excellent service to customers in EU Marketing Companies by enabling rapid and effective submissions and approvals; and seeking to enhance relationships and profile with local Regulatory Authorities.
- Ensures appropriate communication and sharing of relevant EU competitive intelligence information in close collaboration with the RA TA Intelligence functions.
- Ensures best practices are shared within global regulatory.
- Coaches and mentors EU MCRA staff where needed.

**External environment**:

- Together with the EU Policy Directors monitors changes in the regulatory environment to support and advise the EU MCRA, EU businesses, global teams, functions and global regulatory with respect to AZ strategic positions.
- Creates, develops, and optimizes relationships with regulatory agencies, trade associations, and internal groups together with EU MCRA Heads
- Ensures self or others actively represent AZ outside the company (for example trade association meetings) to engage and shape policy on key TA issues to facilitate efficient and effective drug development in the EU.
- Coaches and leads definition of innovative strategies to partner with the relevant regulatory authorities to optimize the predictability of the regulatory outcome and to provide the regulatory platform for optimizing and maintaining market access in the allocated Markets.
- Partners and collaborates effectively with key external stakeholders such EU regulators, Health Authorities, Trade Associations etc.

**Education, Qualifications, Skills and Experience**

**Essential**
- Bachelor’s degree in life sciences and/or science related field and/or other appropriate knowledge/experience.
- More than 10 years of regulatory affairs experience
- Experience in global regulatory strategy and submissions that have progressed through to registration
- Must have significant experience in leading major health Authority interactions
- Ability to work closely with Country Commercial Organization and interact with Regional Leadership and Country Leadership
- Broad background of experience working in pharmaceutical/medical industry and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority, as well as experience to interact with Region’s Officials (e.g., European Commission, European Parliament)
- Experience in managing people in a matrixed organizational structure.
- Ability to think strategically and critically to evaluate risks to regulatory product development and approval, market entry and license maintenance activities for the Region with effective judgement and decision-making in complex business critical situations.
- Strategic influencer of key stakeholders/leaders, innovative, taking initiative, and strong leadership.
- Excellent collaboration, team working, oral and written communication skills.
- Willingness to undertake domestic/international travel.

**Desirable**
- Advanced degree in a scientific discipline (e.g. MSc, PhD, PharmD, MD)

  • Regulatory Affairs Director

    hace 6 meses

    Barcelona, España Consult Search A tiempo completo

    **Scope**: Director of regulatory affairs position that has been opened to further accompany the growth of the company on this sector. Although our client is a historically pharma oriented manufacturer, they have in the recent years expanded their activities in the Medical Aesthetics area, with products currently on market in the Dermal and Hyaluronic acid...

  • Regulatory Affairs Director

    hace 4 semanas

    Barcelona, Barcelona, España Innovaderm Research A tiempo completo

    The Senior Manager, Regulatory Affairs will lead the regional regulatory affairs department at Innovaderm Research, ensuring all services are conducted according to standard operating procedures, applicable regulations, and good clinical practices. Key responsibilities include providing leadership on regulatory activities, planning and assigning work,...

  • Senior Regulatory Affairs Director

    hace 2 días

    Barcelona, España Astrazeneca Gmbh A tiempo completo

    .At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional...

  • Regulatory Affairs Director

    hace 1 mes

    Barcelona, Barcelona, España Innovaderm Research A tiempo completo

    Job SummaryThe Senior Manager, Regulatory Affairs will lead the regional regulatory affairs department to ensure compliance with Innovaderm's standard operating procedures, applicable regulations, and good clinical practices. Key responsibilities include providing strategic guidance on regulatory activities, overseeing the performance of direct reports, and...

  • Regulatory Affairs Senior

    hace 5 meses

    Barcelona, España Page Personnel España A tiempo completo

    To be up to date on changes in legislation and regulations and advises and gives interpretation on the potential impact to the product registration, marketing, manufacturing or development - Submission and follow-up of variations - Preparations of documents to new marketing authorisations (EU and non-EU countries) - Research and Development project managing...

  • Senior Regulatory Affairs Director

    hace 4 días

    Barcelona, España AstraZeneca GmbH A tiempo completo

    At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional...

  • Regulatory Affairs Senior Director of Quality

    hace 7 días

    Barcelona, Barcelona, España Sandoz A tiempo completo

    Job Description: As a Regulatory Affairs Senior Director of Quality, you will lead and manage a team of regulatory professionals within the Regulatory API (RAPI) department, driving the delivery of high-quality documentation to support successful submissions to regulatory authorities. Your key responsibilities include:

  • Senior Regulatory Affairs Director

    hace 4 días

    Barcelona, España Astrazeneca Gmbh A tiempo completo

    At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional...

  • Director - Regulatory Affairs Medtech

    hace 6 meses

    Barcelona, España Alira Health A tiempo completo

    Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Job Description...

  • Senior Regulatory Affairs Director, Global Regulatory Strategy

    hace 3 semanas

    Barcelona, España Astrazeneca A tiempo completo

    .The Senior Regulatory Affairs Director (SRAD), Global Regulatory Strategy will be responsible for overseeing the development and implementation of global regulatory strategies for assigned products in the Cell Therapy Immunology area, with the intention of achieving successful registration and lifecycle management to serve patient needs.You will be...

  • Senior Director, Regulatory Affairs Excellence Eucan

    hace 5 meses

    Barcelona, España AstraZeneca A tiempo completo

    This role coordinates and drives the Business Strategy for EUCAN Marketing Company Regulatory Affairs (EUCAN MCRA) including the digital agenda, simplification, and improvement projects in close collaboration with the Executive Director EUCAN, Senior Regional Director EU and EUCAN Marketing Company Regulatory Affairs (MCRA) Heads and all relevant Global...

  • Senior Regulatory Affairs Director, Global Regulatory Strategy

    hace 3 semanas

    Barcelona, España Astrazeneca A tiempo completo

    .The Senior Regulatory Affairs Director (SRAD), Global Regulatory Strategy will be responsible for overseeing the development and implementation of global regulatory strategies for assigned products in the Cell Therapy Immunology area, with the intention of achieving successful registration and lifecycle management to serve patient needs. You will be...

  • Senior Director/director, Global Regulatory Affairs

    hace 5 meses

    Barcelona, España AstraZeneca A tiempo completo

    Do you have leadership skills and an in depth knowledge within **Regulatory Affairs? **Do you want to work on **innovative projects** of importance for our early Respiratory and Immunology portfolio? At AstraZeneca, we aspire to be pioneers in science, leading in our disease areas and truly transform patient outcomes. This means our people are here to win,...

  • Associate Director, Regulatory Affairs

    hace 1 mes

    Barcelona, España Cpl Healthcare A tiempo completo

    Job Title: Associate Director, Regulatory Affairs - Medical Device/Post-Market Surveillance Job Type: Full Time, Permanent Position Locations: Spain, Madrid – Hybrid Remuneration: Attractive salary and package An exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology and Hepatology.Due...

  • Associate Director, Regulatory Affairs

    hace 3 semanas

    Barcelona, España Cpl Healthcare A tiempo completo

    Job Title: Associate Director, Regulatory Affairs - Medical Device/Post-Market Surveillance Job Type: Full Time, Permanent Position Location: Spain, Madrid – Hybrid Remuneration: Attractive salary and package An exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology.Due...

  • Regulatory Affairs Associate Director

    hace 1 mes

    Barcelona, Barcelona, España Sandoz A tiempo completo

    Job Title: Regulatory Affairs Associate DirectorAs a Regulatory Affairs Associate Director at Sandoz, you will lead a team of regulatory professionals responsible for ensuring the company's compliance with global regulatory standards. Your key responsibilities will include:Leading a team of regulatory associates to drive high-quality documentation and...

  • Director, Regulatory Affairs

    hace 6 meses

    Barcelona, España ICON plc A tiempo completo

    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...

  • Regulatory Affairs Director

    hace 3 semanas

    Barcelona, Barcelona, España Sandoz A tiempo completo

    Job Summary:As Regulatory Affairs Associate Director, you will play a pivotal role in driving and delivering high-quality documentation to support successful submissions, ensuring timely and accurate reporting of regulatory activities, and coordinating the preparation and execution of regulatory documents.Key Responsibilities:• Lead, coach, and mentor...

  • Regulatory Affairs Specialist

    hace 4 semanas

    Barcelona, Barcelona, España FARMAPROJECTS SAU A tiempo completo

    About FARMAPROJECTS SAUFARMAPROJECTS SAU is a B2B Pharmaceutical Laboratory company offering a broad Portfolio of Generic Pharmaceutical Products and Value Added Medicines.We are looking for a new Regulatory Affairs Senior Specialist to join our Regulatory Affairs Department and contribute to the business.About the RoleAs a Regulatory Affairs Senior...

  • Regulatory Affairs Specialist

    hace 1 mes

    Barcelona, España Michael Page ES A tiempo completo

    Reporting to the Regulatory Affairs Director, the Regulatory Affairs Specialist will be primarily responsible for:The preparation, submission, monitoring and updating of regulatory dossiers.Prepare high quality regulatory dossiers (novel food, enzymes, GRAS, etc.) needed for the marketing of our products or those of our business partners in different...