Regulatory Affairs Associate

JR Spain; Barcelona; Presencial; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

A leading global dermatology company in Barcelona is seeking a Specialist in Regulatory Affairs Strategy. This role involves developing regulatory strategies for clinical trials and managing submissions. Candidates should have a strong understanding of regulatory requirements and excellent communication skills. The position offers a hybrid work culture and personalized career development opportunities.

Servicios

Competitive salary

Bonus

Personalized career development opportunities

Diverse and inclusive work environment

Formación

• Experience in pharmaceutical or biological product regulation is required.
• Must have experience with regulatory submissions.
• Strong communication skills for senior leadership are essential.

Responsabilidades

• Develop regulatory strategies for clinical trials.
• Oversee regulatory submissions and compliance.
• Manage interactions with health authorities.

Conocimientos

Knowledge of regulatory requirements for pharmaceutical/biological products

Experience with regulatory submissions in key regions

Ability to communicate strategies and issues effectively to senior leadership

Experience working with regulatory agencies

Strong team interaction skills

Adaptability to change

Descripción del empleo

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Company Overview

With a unique legacy in dermatology and decades of innovation, Galderma is a leading dermatology company, present in approximately 90 countries. We offer an innovative, science-based portfolio of premium brands and services across Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology. Founded in 1981, our focus is on the human body's largest organ - the skin - aiming to meet individual needs with superior outcomes in partnership with healthcare professionals.

We seek individuals focused on results, eager to learn, and positive. Our team values initiative, teamwork, and collaboration, with a passion for making a meaningful impact for consumers, patients, and healthcare professionals. We promote personal growth, diversity, and respect for privacy and dignity across our organization.

Global Capability Center

We are establishing a new Global Capability Center in Barcelona, located in the Eixample District, to support our global teams. This center offers opportunities for professional development through exposure to international projects and global career paths.

Job Title: Specialist, Regulatory Affairs Strategy

Location: Barcelona, Spain (hybrid)

Job Description

• Developing and managing clinical trial regulatory strategies for biologics, ensuring alignment with timelines and responding to health authority queries.
• Overseeing clinical trial regulatory submissions and ensuring compliance.
• Archiving clinical trial documentation.
• Managing interactions with health authorities in designated regions.
• Assessing risks related to regulatory submissions and proposing mitigation strategies.
• Providing updates to global regulatory teams.
• Managing external vendors.

Skills & Qualifications

• Knowledge of regulatory requirements for pharmaceutical/biological products.
• Experience with regulatory submissions in key regions.
• Ability to communicate strategies and issues effectively to senior leadership.
• Experience working with regulatory agencies and implementing strategies.
• Strong team interaction skills and adaptability to change.

What We Offer

• A diverse and inclusive work environment.
• Competitive salary, bonus, and benefits.
• Hybrid work culture.
• Personalized career development opportunities.
• Ownership and accountability from day one.

Next Steps

• Initial virtual interview with a recruiter.
• Follow-up virtual interview with the hiring manager.
• Panel interview with the extended team.

Our people make a difference. Join us to work with diverse, talented individuals who bring unique perspectives and expertise.