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Regulatory Affairs Associate

Regulatory Affairs Associate

Galderma Pharma S.ABarcelona, Cataluña, Spain
Hace 23 días
Descripción del trabajo

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 market through Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day.

Job Title : Specialist, Regulatory Affairs Strategy

Location : Barcelona, Spain (hybrid)

Job Description

The Regulatory Affairs Strategist delivers innovative, breakthrough global regulatory strategies for clinical trial registration with health authorities. The RA Strategist is responsible for regulatory aspects related to clinical trial regulatory submissions in alignment with the global business strategy and in partnership with the functional subject matter experts within the Global R&D.

Key Responsibilities

  • Creating and managing clinical trial regulatory strategy for biologics, executing clinical trial regulatory activities in alignment with agreed clinical timelines, including responses to health authority queries, amendments to clinical trial dossiers, regulatory SUSAR reporting, or any other regulatory activities as needed.
  • Oversight of clinical trial regulatory submissions, ensuring accurate and compliant dossiers.
  • Archiving clinical trial documentation.
  • Managing health authority interaction for assigned regions in alignment with agreed regulatory strategy.
  • Identifying and assessing risks associated with the clinical regulatory submissions and recommend strategies to mitigate these risks.
  • Providing regular updates to global regulatory lead and indication regulatory leads regarding specific clinical trials.
  • Managing of outside vendors.

Skills & Qualifications

  • Knowledge and understanding of regulatory requirements for pharmaceutical / biological product development.
  • Experience with performing regulatory submissions in at least one key regulatory region.
  • Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies.
  • Experience interfacing with regulatory agencies and skill at implementing successful regulatory strategies.
  • Experience with documenting regulatory strategies in coordination with clinical plans and marketing objectives.
  • Excellent team interaction skills along with demonstrated ability to work on a cross-functional team.
  • Ability to identify opportunities / major issues and to communicate impact.
  • Demonstrated ability to deal with rapid change.

    • What we offer in return

  • You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.
  • You will receive a competitive compensation package with bonus structure and extended benefit package.
  • You will be able to work in a hybrid work culture.
  • You will participate in feedback loops, during which a personalized career path will be established.
  • You will be joining a growing company that believes in ownership from day one where everyone is empowered to grow and to take on accountability.

    • Next Steps

  • If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
  • The next step is a virtual conversation with the hiring manager.
  • The final step is a panel conversation with the extended team.

    • Our people make a difference

    At Galderma, you’ll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.

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