- Contribute to global regulatory CMC strategies.
- Assess regulatory impact of proposed CMC changes and contribute to the CMC regulatory strategies that support change implementation.
- Reviews data provided to support dossier preparation; identify gaps and risks and work with stakeholders to solve them.
- Writes/assembles CMC sections of regulatory submissions.
- Develop and maintain project plans and schedules for CMC submissions.
- Ensures all CMC dossiers are stored in the company database.
- Provide guidance minimally 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 goals.
- Share knowledge and experience with other team members.
- Collaborate with service providers contracted to support a project, if appropriate.
- Effective expperience in CMC Regulatory Affairs.
- Background in pharmaceutical industry.
- Experience with topical and/or systemic drugs (Biologics and/or Small Molecules).
- Send your CV in English.
- If your profile is a match, we will invite you for a first virtual conversation with Talent Acquisition.
- The next step is a virtual conversation with the hiring manager.
- The final step is a panel conversation with the extended team.
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RA-CMC Specialist - Barcelona, España - Galderma Pharma S.A
Descripción
About Galderma
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. Because we understand that the skin we're 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 Specialist
Location: Barcelona
Job Description
We are looking for an expert in Regulatory Affairs for preparing and updating the CMC (Chemistry, Manufacturing, and Control) dossier sections of assigned products (Rx or non-monograph OTC drugs). This person will contribute to develop RA-CMC strategies for geographical extension and for post-approval CMC activities.
Key Responsibilities
Skills & Qualifications
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.
Process Steps
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.
Galderma is the world's largest independent dermatology company, present in approximately 100 countries. Since our inception in 1981, we have been driven by a complete dedication to dermatology. We deliver an innovative, science-based portfolio of sophisticated brands and services across Aesthetics, Consumer Care and Prescription Medicine. Focused on the needs of consumers and patients, we work in partnership with healthcare professionals to ensure superior outcomes. Because we understand that the skin we're in shapes our life stories, we are advancing dermatology for every skin story. For more information, please visit our website: .
