Regulatory Affairs CMC Expert - Biologics

Galderma; Barcelona; Híbrido; EUR 60.000 - 100.000; Jornada completa

Descripción de la vacante

An established industry player in dermatology is seeking a Regulatory Affairs CMC Expert to join their innovative team in Barcelona. This pivotal role involves developing global regulatory strategies for biologics, ensuring compliance with FDA and EMA regulations, and collaborating with cross-functional teams. You'll play a crucial part in driving the approval of marketing applications and clinical trials while fostering relationships with internal and external stakeholders. If you are passionate about making a meaningful impact in the field of dermatology and thrive in a dynamic environment, this opportunity is perfect for you.

Servicios

Competitive compensation package

Bonus structure

Extended benefit package

Hybrid work culture

Personalized career path

Formación

• 15+ years in CMC Regulatory Affairs for biologics.
• Experience with FDA/EMA interactions and biologics.
• Strong problem-solving and analytical skills.

Responsabilidades

• Develop global regulatory CMC strategies for biologics.
• Prepare CMC sections of regulatory submissions.
• Manage interactions with Health Authorities.

Conocimientos

Regulatory Affairs

Biologics

FDA regulations

EMA regulations

Project Management

Analytical Skills

Communication Skills

Problem Solving

Educación

BSc in a scientific discipline

MSc in a scientific discipline

Pharmacist

Descripción del empleo

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare 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. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story.

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. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

Further supporting our growth and innovation momentum, we are establishing a new Global Capability Center in Barcelona to deploy new capabilities to effectively support its global commercial and functional teams. Located in the upscale Eixample District in the heart of Barcelona, Galderma’s Global Capability Center offers numerous possibilities for professional development such as exposure to global and cross-functional projects and access to global career opportunities.

Job Title: Regulatory Affairs CMC Expert - Biologics

Location: Barcelona, Spain (hybrid)

Job Description

The Regulatory Affairs CMC Expert is responsible for preparing and updating the CMC dossier sections of assigned products (focused on biologics). Develop CMC regulatory strategies and establish data requirements worldwide and prepares CMC sections of regulatory submissions for investigational and commercial products.

The role reports to Head of Regulatory Affairs CMC Drugs

Key Responsibilities

• Develop global regulatory CMC strategies to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which include CMC information
• Writes/assembles CMC sections of regulatory submissions including clinical trial and variations/supplements as well as registration submission worldwide ensuring alignment with regulations, guidelines, policies and procedures
• Manage answers to questions from the Authorities in a timely and effective manner to ensure early approval
• Participate to interactions with Competent Authorities if needed
• Develop and maintain project plans and schedules for CMC submissions
• Evaluate proposed manufacturing changes for global impact and provide regulatory strategies that support change implementation.
• Review data provided to support dossier preparation; identify gaps and risks and work with stakeholders to solve them.
• Provide guidance on ICH, FDA and EU CMC guidelines
• Develop and maintain excellent relationships with internal functional groups, contract manufacturing organizations and other relevant partners to ensure alignment of regulatory CMC strategies and successfully accomplish regulatory objectives
• Represent the Regulatory Affairs CMC function on assigned cross-functional project teams

Skills & Qualifications

• BSc, MSc in a scientific discipline or Pharmacist
• At least 15 years in CMC Regulatory Affairs for biologics
• Experience with biologics and/or combination products
• Experience in interactions with Health Authorities (FDA/EMA)
• Focused on effective delivery of objectives, even when working with tight deadlines
• Planning, organizing and time management skills;
• Problem solving and analytical skills;
• Ability to identify opportunities/major issues and to communicate impact;
• Demonstrated ability to deal with rapid change;
• Effective verbal and written communication skills in a cross functional environment and with external partners
• Fluent in English

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.