Regulatory Affairs Associate Director

hace 1 semana

Barcelona, España buscojobs España A tiempo completo

As Regulatory Affairs Associate Director, you will lead associates within Regulatory API (RAPI), accountable for driving and delivering high quality documentation supporting successful submission, within agreed timelines and project plans. This includes preparation of registration documentation and assessment of appropriateness of registration documentation for active ingredients/intermediates.

Your responsibilities will include:

  • Lead, coach and mentor associates. Ensure sufficient training and development opportunities to maximize regulatory competence.
  • Take responsibility for financial targets including but not limited to cost center responsibility.
  • Ensure and/or support timely and accurate reporting of regulatory activities.
  • Perform and/or support analyzing group performance and making recommendations for improvement within the team.
  • Coordinate the preparation and execution of regulatory documents. Ensure regulatory CMC submissions are of high quality, consistent and complete, and comply with current global regulatory standards.
  • Formulate, lead and drive global regulatory strategy with a focus on maximizing business benefits balanced with regulatory compliance for drug substances.
  • Generate, review and approve internal regulatory guidance documents, protocols, and reports within assigned projects.
  • Establish and maintain sound working relationships with colleagues, partners, and customers. Provide regulatory guidance to cross-functional teams, and determine regulatory impact for changes in chemistry, manufacturing, and control procedures. Support and/or lead global regulatory projects/initiatives.
  • Keep knowledge up to date regarding regulatory guidelines and requirements in all global regions as well as for new technical trends. Responsible for the transfer of knowledge and experiences to the organization.
  • Liaise under minor supervision with regulatory agencies and represent the company in regulatory meetings and discussions.
  • Work according to internal and external guidance, SOPs, and respective timelines.

What you'll bring to the role:

  • PhD (natural science: chemistry, pharmacy, biology or related fields) with at least 3 years of work-related post-doctoral/industrial experience, or Master/BSc (natural science: chemistry, pharmacy, biology or related fields) with at least 3 years of work-related experience including people management experience.
  • Leadership experience within the regulatory affairs function.
  • Broad knowledge of Module 3.
  • Broad knowledge of regulatory guidelines.
  • Good knowledge of relevant software tools.
  • Good skills in presentation and scientific/technical writing.
  • Good documentation skills and ability to understand and follow written procedures accurately.
  • Fluent oral and written English. Fluent in Spanish.

Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit are powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged

The future is ours to shape

Commitment to Diversity & Inclusion:

Sandoz is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

#J-18808-Ljbffr

  • Associate Regulatory Affairs Director I

    hace 2 meses

    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...

  • 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 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...

  • Cmc Regulatory Affairs Associate Director

    hace 3 meses

    Barcelona, España AstraZeneca A tiempo completo

    **Location: Barcelona, Spain (we requiere 3 days working from the office and 2 days working from home** Our **Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs** function delivers expert CMC regulatory input for projects spanning across the product lifecycle and leads the regulatory strategy for the development, manufacturing and testing of...

  • Regulatory Affairs Associate

    hace 1 semana

    Barcelona, España buscojobs España A tiempo completo

    Regulatory Affairs AssociateBarcelona, CataloniaGalderma - 28.11.2024With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative approach to dermatological care.Regulatory Affairs AssociateBarcelona, CataloniaGlobal...

  • Regulatory Affairs Associate

    hace 2 semanas

    Barcelona, España buscojobs España A tiempo completo

    Regulatory Affairs AssociateBarcelona, CataloniaGalderma - 28.11.2024With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative approach to dermatological care.Regulatory Affairs AssociateBarcelona, CataloniaGlobal...

  • Regulatory Affairs Associate Director

    hace 2 meses

    Barcelona, España Sandoz A tiempo completo

    .As Regulatory Affairs Associate Director, you will lead associates within Regulatory API (RAPI), accountable for driving and delivering high quality documentation supporting successful submission, within agreed timelines and project planes. Including preparation of registration documentation and assessment of appropriateness of registration documentation...

  • Regulatory Affairs Associate Director for CMC Specialists

    hace 4 semanas

    Barcelona, Barcelona, España Az Farmacéutica Spain S.A A tiempo completo

    About the RoleWe are seeking a highly skilled Regulatory Affairs Associate Director to join our CMC team in Barcelona, Spain.Key Responsibilities* Provide strategic, tactical, and operational expertise to project teams* Develop creative strategies to support new biological entities and novel products* Collaborate with cross-functional teams to ensure...

  • Regulatory Affairs Associate Director

    hace 2 meses

    Palafolls, Barcelona provincia, España Sandoz A tiempo completo

    As Regulatory Affairs Associate Director, you will lead associates within Regulatory API (RAPI), accountable for driving and delivering high quality documentation supporting successful submission, within agreed timelines and project planes. Including preparation of registration documentation and assessment of appropriateness of registration documentation for...

  • Cmc Regulatory Affairs Associate Director Biologics

    hace 2 meses

    Barcelona, España AstraZeneca A tiempo completo

    **CMC Regulatory Affairs Associate Director Biologics** **Location - Barcelona** **Competitive salary and benefits package** **Introduction to role** Join our dynamic team at AstraZeneca as a CMC Regulatory Affairs Associate Director. Based in our Barcelona, Spain hub, you will be a core member of our cross-functional Regulatory Strategy,...

  • Regulatory Affairs Associate Director

    hace 1 semana

    Barcelona, España buscojobs España A tiempo completo

    As Regulatory Affairs Associate Director, you will lead associates within Regulatory API (RAPI), accountable for driving and delivering high quality documentation supporting successful submission, within agreed timelines and project plans. This includes preparation of registration documentation and assessment of appropriateness of registration documentation...

  • Regulatory Affairs Associate Director

    hace 2 meses

    Barcelona, España Sandoz A tiempo completo

    As Regulatory Affairs Associate Director, you will lead associates within Regulatory API (RAPI), accountable for driving and delivering high quality documentation supporting successful submission, within agreed timelines and project planes. Including preparation of registration documentation and assessment of appropriateness of registration documentation for...

  • Regulatory Affairs Associate Director

    hace 7 meses

    Barcelona, España AstraZeneca A tiempo completo

    Welcome to AstraZeneca, where we prioritize patients and strive to meet their needs globally. We are a team of entrepreneurial thinkers, big dreamers, and collaborators who work together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of...

  • Regulatory Affairs Associate

    hace 14 horas

    Barcelona, España Galderma Pharma S.A A tiempo completo

    .Regulatory Affairs Associate With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology...

  • Associate Director of Translational Regulatory

    hace 2 meses

    Barcelona, España AstraZeneca A tiempo completo

    **Location: Barcelona (on-site)** Within Oncology Regulatory Science, Strategy & Excellence (ORSSE), we bring hope and solutions to patients across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We work across our...

  • Regulatory Affairs Associate

    hace 6 meses

    Barcelona, España Argenta A tiempo completo

    **Who are we?** **The Opportunity** Due to continued growth we are looking to recruit a Regulatory Affairs Associate (specifically for feed) to join our consultancy. You will get the opportunity to work alongside our experienced team on a variety of challenging and innovative projects within the animal nutrition sector. Day to day you will manage our...

  • Translational Regulatory Affairs Director

    hace 4 semanas

    Barcelona, España Astrazeneca A tiempo completo

    Location: Barcelona (on-site)Are you a strategically focused Regulatory professional who would like to play an integral part in bringing life changing Oncology medicines to patients? If so, please join us!At AstraZeneca, we work with diverse minds, all united by a shared passion to learn, grow and discover.Within Oncology Regulatory Science, Strategy &...

  • Senior Regulatory Affairs Director

    hace 3 semanas

    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 Associate

    hace 6 meses

    Barcelona, España AstraZeneca A tiempo completo

    **Location: Barcelona (On-site)** Are you passionate about **science**, **drug development**, **project management **and **regulatory affairs**? At AstraZeneca, we are driven by innovation and our dedication to make a real-life difference in patients’ lives. That difference starts with you. We need people who share our passion for science and...

  • Regulatory Affairs Associate

    hace 1 mes

    Barcelona, España Galderma Pharma S.A A tiempo completo

    Regulatory Affairs Associate With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries.We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology...

  • Regulatory Affairs Associate

    hace 1 mes

    Barcelona, España Galderma Pharma S.A A tiempo completo

    Regulatory Affairs AssociateWith a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology...