Senior Regulatory Affairs Manager

Galderma S.A. Dutch Branch; Amsterdam; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Galderma S.A. Dutch Branch is seeking a Senior Regulatory Affairs Manager in Amsterdam to oversee MAH regulatory activities for pharmaceutical products and contribute to lifecycle management across EU jurisdictions.

You will act as the regulatory point of contact for Health Authority inspections, lead regulatory intelligence efforts, and coordinate strategy and submissions with cross-functional teams in a fast-paced global environment. Fluency in English and Dutch is required.

Qualifications

• Scientific degree (BSc, MSc, PhD) or Pharmacist qualification.
• 10 years of experience in Regulatory Affairs, including Lifecycle Management and Health Authority inspections.
• Experience managing outsourced Regulatory Dossier activities and international projects.
• Ability to deliver results in a fast-paced environment with tight deadlines.
• Fluent in English and Dutch.

Responsabilités

• MAH responsibilities with global oversight for pharmaceutical products.
• Be the point of contact for Health Authority inspections and regulatory sessions.
• Lead Regulatory Intelligence activities focusing on European regulations.
• Perform lifecycle management activities for centrally authorized products.
• Coordinate regulatory strategy and dossier preparation with core documents.

Connaissances

Regulatory Affairs

Lifecycle Management

Health Authority liaison

Regulatory Strategy

Regulatory Intelligence

Cross-functional leadership

English & Dutch

Formation

Scientific degree or Pharmacist qualification

Description du poste

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.

Job Title : Senior Regulatory Affairs Manager Location : Amsterdam - Netherlands

As the Regulatory Affairs (RA) Point of Contact for Galderma SA Netherlands (GSA NL), the Marketing Authorization Holder (MAH) for centrally authorized products and several EU countries, you will ensure MAH oversight of all regulatory activities for both EU-based entities and international activities, with a primary focus on pharmaceutical products and some oversight of cosmetic products. The role is part of the Global Regulatory function and includes acting as the Regulatory Affairs point of contact during Health Authority inspections. You will conduct Regulatory Intelligence activities and leading selected initiatives, as well as managing service providers supporting the function, where applicable. You will also be in charge of Lifecycle Management (LCM) activities for pharmaceutical products.

Key Responsibilities

MAH responsibilities maintain a global oversight with the different entities in the group to ensure MAH responsibilities from a PV / Quality and RA activities standpoint with main focus on pharmaceutical products ensure oversight of LCM activities and when GSA NL entity is used in development activities for pharmaceuticals (if applicable) be the point of contact for any regulatory assessment linked to this specific entity of GSA NL Branch be the point of contact for any Health Authority inspection and ensure the coordination of the preparation and the regulatory requests / sessions LCM activities for pharmaceuticals EMA contact point for centralized products in charge of LCM activities for pharmaceutical products with activities such as maintenance of licenses, coordination with Pharmacovigilance for safety variations, marketing and medical for labelling changes and RA CMC for quality variations activities include (but not limited to) regulatory strategy, dossier preparation (with regulatory review / input on core documents such as clinical overview), coordination of answer documents in case of HA questions, follow-up of the approval provide RA input if applicable in PV documents such as PBRER, DSUR and RMP ensure and update all regulatory databased (Regulatory Information Management System / Electronic Data Management System ...) Regulatory Intelligence monitor internal and professional communications concerning relevant regulations (ICH, EMA, …) and perform regulatory intelligence activities with a focus on European regulation including all the requirements linked to the database and new ways of submitting changes - prepare the gap analysis for the coming new EU pharma law from the identified changes in the process of this new EU pharm, lead the overall process update within Global Regulatory Affairs (GRA) perform the impact analysis of transverse regulations such as the Packaging and Packaging Waste Regulation (PPWR) and propose action plans in close collaboration with affiliates prepare ad-hoc summaries and communication tools to inform relevant stakeholders / management Management Regulatory Service Providers provides input to maintain and improve processes with regulatory service providers for the activities if applicable Quality ensures that all regulatory documents are prepared and tracked in EDMS and that all regulatory activities are tracked in the regulatory affairs database Initiates, reviews and contribute to SOPs, forms, etc. to support regulatory development processes. contributes to improvements to processes and to ensure continued compliance with applicable regulations

Skills & Qualifications

Scientific degree (BSc, MSc, PhD) or Pharmacist qualification 10 years of experience in Regulatory Affairs, including Lifecycle Management activities for centrally authorized products and Health Authority inspections Experience managing outsourced Regulatory Dossier activities and international projects Ability to deliver results effectively in a fast-paced environment with tight deadlines Experience interacting with regulatory agencies and contributing to global regulatory strategies Strong cross-functional collaboration skills, with the ability to influence and motivate teams Proven transversal leadership skills Excellent organizational, planning, analytical, and problem-solving skills Ability to identify opportunities and critical issues, assess impact, and communicate effectively Adaptability to changing priorities and dynamic environments Excellent verbal and written communication skills Fluent in English and Dutch

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. 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 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. For more information go to www.galderma.com/careers

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. For more information go to www.galderma.com/careers