Director Regulatory Intelligence

hace 5 meses

Barcelona, España AstraZeneca A tiempo completo

Do you have **competitive** **intelligence** skills and in-depth knowledge about **Regulatory Affairs**? Do you want to work on **innovative projects** of high importance for our **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, we give you a breadth of opportunities to be curious and do cutting edge, unique work that has significant impact on science, medicines, and patients.

**The role**

We now have a great opportunity for you to join our team within Respiratory and Immunology (R&I) in the roles as Senior Global Regulatory intelligence Director.

***

**What you’ll do**

**The SRID will**:

- Work closely with other Intelligence and Policy groups within AZ for example Regulatory Policy, Intelligence and Regional Strategy (PIRS), Clinical Information Science, and Global Insights, Analytics, and Commercial Excellence (GIACE).
- Collaborate with TA-VP RA, Executive regulatory science directors (ERSD), Global Regulatory Leads (GRLs), Senior RADs/RADs and Regulatory Affairs Managers (RAM) to provide the Regulatory Intelligence aspect of disease areas and product-specific Regulatory strategies.
- Liaise with PIRS on policy matters, lead the AZ responses to health authority draft guidance’s in call for comments processes by acquiring input from all relevant AZ skills within the therapeutic area.
- Collaborate with International, China, and Japan RADs regarding disease area-specific guidance and regulatory intelligence aspects in each region, contributing to overall Regulatory landscape per disease.
- Represent AZ, R&I/RA to trade and scientific associations, serving on working groups and sub-committees; preparing AZ/R&I positions and feedback as appropriate.

**Essential for the role**
- A Bachelors degree in a science related field and/or other appropriate knowledge/experience.
- At least 7 years of demonstrated ability in regulatory strategy or regulatory intelligence, including prior experience interacting with and influencing senior leaders in a medium to large organization
- Proficiencies in data impact analysis, strategic thinking, creative problem solving and excellent oral and written communication skills.
- Ability to evaluate the impact of key Regulatory Intelligence on disease area and project strategy
- Ability to critically distinguish between “noise” and relevant news to key collaborators and senior leaders
- You have a solid understanding about Regulatory Intelligence Tools and stays current with Regulatory news regarding key competitors and the disease area.
- You have a detailed understanding of drug development and are proactive with a consistent record collaborating across diverse functions

**Desirable for the role**
- Solid understanding of the commercial aspects of drug development
- In-depth knowledge of the R&I therapeutic area
- Broad background of experience working in pharmaceutical business and prior experience in leading competitive intelligence within the pharmaceutical industry or in associated industries
- Critical thinking on current global regulatory science trends and questions with a good understanding of the corresponding scientific and clinical components.
- Previous experience in working with external trade and scientific associations.

**Why AstraZeneca?**
- At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being ambitious - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, groundbreaking methods, and bringing unexpected teams together. Interested? Come and join our journey._

**So, what’s next?**
- Are you ready to bring new insights and fresh thinking to the table? Brilliant We have one seat available, and we hope it’s yours._

  • Regulatory Intelligence Director Oncology

    hace 5 meses

    Barcelona, España AstraZeneca A tiempo completo

    **Location: Barcelona, Spain** **_ Would you like to use your Regulatory Intelligence skills to ultimately help get Oncology medicines to patients that need them? If you would please read on..._** At AstraZeneca work with a diverse set of minds, all united by a shared passion to learn, grow and discover. Within **Oncology Regulatory Science and Strategy...

  • Mgr, Regulatory Intelligence

    hace 7 meses

    Barcelona, España Syneos - Clinical and Corporate - Prod A tiempo completo

    **Description** **JOB SUMMARY**: The Regulatory Intelligence Department at Syneos Health impact decision-making at the highest levels. The team translate and refine Syneos Health regulatory intelligence from internal and external sources and combine knowledge from therapy areas and functions to deliver proactive advice outlining risks and new opportunities...

  • Regulatory Intelligence Specialist

    hace 3 semanas

    Barcelona, Barcelona, España Iqvia A tiempo completo

    Regulatory Intelligence SpecialistWe are seeking a highly skilled Regulatory Intelligence Specialist to join our team at the Madrid Center of Excellence office.This position will provide broad support on monitoring and analyzing the changes and evolution of the local regulatory environment, including guidance and regulations from regulatory authorities,...

  • Regulatory Intelligence Specialist

    hace 3 semanas

    Barcelona, Barcelona, España Iqvia A tiempo completo

    We are seeking a highly skilled Regulatory Intelligence Specialist to join our team at our Madrid Center of Excellence office. This position will provide broad support on monitoring and analyzing the changes and evolution of the local regulatory environment, including guidance and regulations from regulatory authorities, trade organizations, working groups,...

  • Lead Product Manager

    hace 4 semanas

    Barcelona, Barcelona, España Clarivate Analytics A tiempo completo

    About the RoleWe are seeking a highly skilled and experienced Lead Product Manager to join our team and drive the strategic vision and growth of our Regulatory Intelligence platform.This is a pivotal role that requires a strong commercial acumen and a deep understanding of the drug development market, industry trends, competitive dynamics, and the needs of...

  • Lead Product Manager

    hace 4 semanas

    Barcelona, Barcelona, España Clarivate Analytics A tiempo completo

    About the RoleWe are seeking a highly skilled and experienced Lead Product Manager to join our team and drive the strategic vision and growth of our Regulatory Intelligence platform.This is a pivotal role that requires a strong commercial acumen and a deep understanding of the drug development market, industry trends, competitive dynamics, and the needs of...

  • 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 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 2 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 Director

    hace 5 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...

  • Director, Regulatory Affairs

    hace 5 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,...

  • Director - Regulatory Affairs Medtech

    hace 5 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...

  • Lead Product Manager

    hace 3 meses

    Barcelona, España Clarivate Analytics A tiempo completo

    Lead Product Manager - Regulatory IntelligenceWe are seeking a dynamic and experienced Lead Product Manager to join our team and drive the strategic vision and growth of our Regulatory Intelligence platform.As a skilled product strategist with a significant background in regulatory and CMC information solutions, you will play a pivotal role in shaping our...

  • Regulatory Affairs Director

    hace 2 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...

  • Executive Director Eucan Regulatory Affairs

    hace 5 meses

    Barcelona, España AstraZeneca A tiempo completo

    The Executive Director EUCAN provides global strategic regulatory expertise and oversight to support the EUCAN countries and integrate the EUCAN countries into the global Regulatory Affairs network of AstraZeneca. The Executive Director EUCAN organizes the relevant Marketing Companies (MC) network and ensure their regulatory organizations are included in the...

  • Regulatory Affairs Associate Director

    hace 3 semanas

    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...

  • Regulatory Director Barcelona

    hace 5 meses

    Barcelona, España Belmonte Group A tiempo completo

    Description **Job Description**: As a regulatory director for a UAV (unmanned aerial vehicle) company, you would be responsible for ensuring that the company's operations comply with all relevant laws, regulations, and guidelines related to UAVs, specifically for each of the company’s customers. **Requirements**: - At least 5 years of experience working...

  • Regulatory Affairs Director

    hace 3 semanas

    Barcelona, Barcelona, España Sandoz A tiempo completo

    As a Regulatory Affairs Associate Director at Sandoz, you will lead a team of associates within the Regulatory API department, driving and delivering high-quality documentation to support successful submissions. Your responsibilities will include leading, coaching, and mentoring associates, ensuring sufficient training and development opportunities to...

  • Associate Regulatory Affairs Director I

    hace 4 semanas

    Barcelona, España Astrazeneca Gmbh A tiempo completo

    Job Title: Associate Regulatory Affairs Director ICareer Level - EIntroduction to Role:Join our Oncology R&D team as an Associate Regulatory Affairs Director I. This role is perfect for an experienced regulatory specialist with strong project management capabilities. You will be responsible for leading the end-to-end planning, coordination, and execution of...

  • Regulatory Affairs Director

    hace 3 semanas

    Barcelona, Barcelona, España Sandoz A tiempo completo

    Job DescriptionAs a Regulatory Affairs Associate Director at Sandoz, you will lead a team of associates within the Regulatory API (RAPI) department. Your primary responsibility will be to drive and deliver high-quality documentation to support successful submissions, adhering to agreed timelines and project plans. This includes preparing registration...

  • Director, Quality and Regulatory

    hace 2 meses

    Barcelona, España Thermo Fisher Scientific A tiempo completo

    **Work Schedule** Other **Environmental Conditions** Office We are currently seeking a highly motivated and experienced Director, Quality and Regulatory to join our Engineering team at Thermo Fisher Scientific Inc. As a world-class leader in the industry, Thermo Fisher Scientific Inc. provides exceptional opportunities for growth and...