Regulatory Affairs Director

Director of Regulatory Affairs for CMC Biologics & Rare Diseases Category: Project Management & Agile Location: Søborg, Capital Region of Denmark, DK Are you an experienced purpose-driven and business-minded second line leader with extensive expertise in drug regulatory affairs? Do you excel in a dynamic environment and want to be part of a rapidly...

Job Description:The Director of Regulatory Affairs for CMC Biologics will lead the development and execution of regulatory strategies for biologics and rare diseases. This role requires a seasoned leader with extensive experience in regulatory affairs, able to inspire and empower teams to deliver high-quality results.Key Responsibilities:Develop and execute...

About the RoleWe are seeking an experienced Regulatory Affairs Chemistry, Manufacturing and Control (RA CMC) Specialist with expertise in synthetic small molecules to join our team. As a key member of our regulatory affairs department, you will provide strategic, tactical, and operational regulatory input to projects. Your responsibilities will include...

About the DepartmentDigital Transformation is a department placed in RQ&C: RQ&C consists of the four functional areas: Regulatory Affairs (approvals by health authorities), R&D Quality (ensuring quality and compliance), Clinical Reporting (medical writing) and Digital Transformation (driving the Digital agenda). Furthermore, our department also supports the...

Select how often (in days) to receive an alert: Create Alert (Senior) Regulatory Affairs Professional, RA Obesity - Maternity cover Category: Reg Affairs & Safety Pharmacovigilance Location: Søborg, Capital Region of Denmark, DK Do you have a talent for navigating complex regulatory landscapes and driving strategic initiatives? Are you eager to contribute...

About the RoleWe are seeking a talented Senior Regulatory Business Analyst to join our dynamic team at Novo Nordisk A/S. As a key member of the Regulatory Affairs department, you will play a critical role in driving business analysis and process improvements across the organization.Your primary responsibilities will include:Business Analysis: Identify...

About the RoleNovo Nordisk A/S is seeking an experienced Regulatory Affairs Process Excellence Manager to join our RA Process and Digital Strategy area. As a key member of the team, you will play a central role in driving process excellence, innovation, and digital transformation across the regulatory affairs organization at a corporate level and across all...

Job Overview:We are seeking a highly experienced and visionary leader to spearhead our team as the Director of Regulatory Affairs for CMC Biologics and Rare Diseases. This role requires a dynamic and ambitious individual with a strong track record of driving change and innovation in regulatory affairs.Key Requirements:A Master of Science degree in natural...

About the RoleThe Governmental Public Affairs & Communications Head will be responsible for developing and implementing strategic engagement plans to build coalitions with external stakeholders. This includes monitoring legislative and regulatory developments, engaging with government officials, and managing public policy matters.Key...

Come work at the forefront of science - and help the brands you grew up with grow and evolve into the next generation. Job Description - Senior Regulatory Affairs Specialist (2507030367W) Who we are At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of iconic brands —...

Job Summary:The Director of Regulatory Affairs for CMC Biologics will be responsible for developing and executing regulatory strategies for biologics and rare diseases. This role requires a highly experienced and visionary leader who can inspire and empower teams to deliver high-quality results.Key Challenges:Developing and executing global approval...

Select how often (in days) to receive an alert: Create AlertCategory: Reg Affairs & Safety PharmacovigilanceLocation: Søborg, Capital Region of Denmark, DKWe are expanding our product and project pipeline in Novo Nordisk and are looking for an engaged Regulatory Affairs Chemistry, Manufacturing and Control (RA CMC) Specialist with expertise in synthetic...

About the TeamThe RA Process and Digital Strategy area within Regulatory Affairs is a growing team of 10 people, committed to securing process excellence and digital innovation to reach more patients faster.We work across the value chain from early development to product discontinuation, ensuring medicine availability to patients. Our team is based at our...

Are you passionate about working with data? Do you want to set directions and deliver results? Do you have the ability to handle complex tasks? If yes, we are seeking an experienced and highly motivated Regulatory Data Partner to join our team, who will be responsible for implementing and supporting our data in the Regulatory organisation, and support...

Job SummaryWe are looking for a highly motivated and detail-oriented Compliance Engineer to join our team. As a Compliance Engineer, you will play a key role in ensuring that our facilities and processes meet regulatory requirements.About the PositionYou will be part of the Plant Engineering department, responsible for implementing and maintaining quality...

Key Responsibilities and SkillsThe Governmental Public Affairs & Communications Head at Merck will be responsible for:Developing and implementing strategic engagement plans to build coalitions with external stakeholders. Monitoring legislative and regulatory developments. Engaging with government officials and policymakers. Managing public policy matters....

About the TeamThe RA Process and Digital Strategy area within Regulatory Affairs is a growing team of 10 people. We are committed to securing process excellence and digital innovation to reach more patients faster by standardising ways of working with a focus on end users.Our mission is to make work easier and more rewarding for our colleagues. In Regulatory...

Job DescriptionWe are seeking a highly skilled Senior Regulatory Business Analyst to join our team at Novo Nordisk A/S. As a key member of the Regulatory Affairs department, you will play a critical role in driving business analysis and process improvements across the organization.Your primary responsibilities will include:Business Analysis: Identify...

The Ideal CandidateWe are looking for an experienced Regulatory Affairs Chemistry, Manufacturing and Control (RA CMC) Specialist with expertise in synthetic small molecules to join our team. The ideal candidate will have a Master's and/or Ph.D. degree in life sciences with regulatory CMC experience either from the pharmaceutical industry or from a health...

Job DescriptionWe are seeking a talented Senior Regulatory Business Analyst to join our team at Novo Nordisk A/S. This role is an exciting opportunity to work with diverse data from various core systems, driving analysis, performance, and insights to enable optimal decision making across business units.The successful candidate will be responsible for...