Regulatory Compliance Expert for Biopharmaceutical Development

4 days ago


Copenhagen, Copenhagen, Denmark Ascendis Pharma AS Full time

We are seeking a highly skilled Regulatory Compliance Expert to join our Quality Assurance team at Ascendis Pharma A/S. As a key contributor, you will play a vital role in ensuring the quality oversight of outsourced development activities carried out at Contract Laboratories and Manufacturing Organizations.

Our company has its roots spanning Denmark, Germany, and the United States, emerging as an innovative and dynamic biopharmaceutical company. We are passionate about Quality Assurance and committed to delivering high-quality products.

The successful candidate will be responsible for driving the Quality Oversight for a development project while collaborating and contributing to ongoing work on different projects in our development pipeline. This includes sparring with the team of highly skilled development SMEs in the CMC department, guiding them in quality-related topics, and supporting general quality work and quality oversight needed for a fast-paced development organization.

Key Responsibilities:

  • Responsible for Quality Oversight of outsourced complex analytical and manufacturing activities at Contract organizations located globally.
  • Sparring with the team of highly skilled development SMEs in the CMC department, guiding them in quality-related topics.
  • General support for quality work and quality oversight needed for a fast-paced development organization.

Requirements:

  • Masters' degree in Pharmaceutical sciences, Chemistry, Biotechnology, Engineering, or equivalent with more than 2 years of experience in a GMP environment.
  • Accustomed to working with outsourcing of analytical methods and analytical development.
  • Knowledgeable with requirements set out by different health authorities and interpretation of these.

Competencies:

  • Curiosity: Demonstrates a strong desire to learn and understand new concepts and ideas.
  • Solution-Oriented: Focuses on identifying and implementing effective solutions to problems proactively.
  • Pragmatic Mind-Set: Approaches tasks and challenges with practical and realistic strategies.
  • Guidance to Stakeholders: Provides clear and actionable guidance and sparring to both internal and external stakeholders.
  • Communication Skills: Excellent ability to convey information and ideas effectively.
  • Analytical Thinking: Strong capability to analyze situations and data to make informed decisions.
  • Collaboration: Works well with others to achieve common goals.
  • Adaptability: Easily adjusts to changing circumstances and environments.
  • Independence: Capable and thriving working autonomously and making decisions.

Travel: Approximately 20 days per year.


  • Compliance Expert

    6 days ago


    Copenhagen, Copenhagen, Denmark Gn Hearing AS Full time

    Role OverviewThe Compliance Assistant will play a critical role in supporting the Director of Group Business Ethics & Compliance in driving regulatory compliance across the organization.


  • Copenhagen, Copenhagen, Denmark Corti Full time

    About the RoleWe are looking for a highly skilled Regulatory Compliance Specialist to oversee the development and implementation of our quality management systems. The successful candidate will be responsible for assessing and mitigating risks, creating technical documentation, and ensuring compliance with relevant regulations and standards.Key...


  • Copenhagen, Copenhagen, Denmark Syneos Health, Inc. Full time

    Company Overview: Syneos Health, Inc. is a fully integrated biopharmaceutical solutions organization that puts the customer and patient at the center of everything we do. Our company's model brings together the best practices of clinical development, commercialization, and healthcare expertise to deliver innovative solutions to our clients. With a passion...


  • Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

    Novo Nordisk A/S is committed to creating an inclusive culture that celebrates diversity and promotes innovation.As a Biopharmaceutical Development Manager, you will play a critical role in shaping our organization's future by developing and executing strategies for biopharmaceutical development.Key responsibilities include:Leading cross-functional teams to...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    At Genmab A/S, we're committed to delivering innovative antibody therapeutics that change the lives of patients and transform the future of cancer treatment.The Regulatory Affairs CMC team is responsible for ensuring the global regulatory compliance of our biological products throughout their development and commercialization lifecycle. We are seeking a...


  • Copenhagen, Copenhagen, Denmark Organon ApS Full time

    Job OverviewWe are seeking a highly skilled Global Trade Compliance Expert to join our team at Organon ApS.This role will be part of the Global Logistics Services (GLS) team, complementing the Global Trade Compliance Center of Excellence and reporting to the Director Global Trade Compliance.The successful candidate will be responsible for orchestrating...


  • Copenhagen, Copenhagen, Denmark Organon ApS Full time

    Job OverviewOrganon ApS, a global healthcare company, is seeking a highly skilled Global Trade Compliance Expert to join our team. This role will be responsible for overseeing processes, aligning standards and guidelines, and driving relevant analytics to ensure compliance with laws and regulations across various regions.The ideal candidate will have a...


  • Copenhagen, Copenhagen, Denmark PARETO SECURITIES AS Full time

    What We're Looking ForWe're seeking a dynamic and experienced leader with a strong background in compliance and risk management. As Head of Legal and Compliance, you will play a crucial role in shaping our compliance strategy and ensuring the company's adherence to legal and regulatory frameworks.Key responsibilities include leading and mentoring the legal...


  • Copenhagen, Copenhagen, Denmark AGC Inc Full time

    IT Application Solutions ExpertCopenhagen, Denmark - Full time jobAbout the RoleAn IT Application Solutions Expert is needed to manage changes to existing configured screens or fields.Main Responsibilities:Manage project configurations according to customer requirements.Collect and analyze customer needs, then recommend product updates.Create and maintain...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About GenmabAs a pioneering biotechnology company, Genmab is dedicated to developing innovative antibody therapeutics that transform the lives of patients with cancer. Our passionate team has spent over two decades pushing the boundaries of translational research and data sciences.We have developed a proprietary pipeline featuring bispecific T-cell engagers,...


  • Copenhagen, Copenhagen, Denmark Rambøll Full time

    Sustainable change starts with responsible leadership. At Ramboll, our core strength is our people, and our history is rooted in a clear vision of how a responsible company should act.Job ResponsibilitiesWe are looking for a Senior Global Speak Up Manager to join our Group Business Integrity, Cyber and Information Security & Compliance Department. The ideal...


  • Copenhagen, Copenhagen, Denmark Dealflow Full time

    Company OverviewWe are a next-generation fintech company that aims to empower entrepreneurs and small businesses with financial superpowers. Our mission is to back the brave founders who dare to challenge the status quo and create a more just and equitable financial system.Salary and BenefitsWe offer a competitive compensation package that includes a sizable...


  • Copenhagen, Copenhagen, Denmark Copenhagen Infrastructure Service Co. Full time

    Job Summary:Copenhagen Infrastructure Service Company is hiring an ESG Compliance Specialist to drive compliance initiatives and contribute to the company's sustainability goals.Core Responsibilities:Ensure investments comply with regulatory requirements, including SFDR and other applicable laws.Improve the ESG compliance framework to enhance taxonomy...


  • Copenhagen, Copenhagen, Denmark Copenhagen Infrastructure Service Co. Full time

    Role OverviewCopenhagen Infrastructure Service Company (CISC) is seeking an experienced ESG Compliance Specialist to join their team in Copenhagen, Denmark. As a key member of the ESG team, you will play a crucial role in ensuring SFDR compliance and contributing to the development of our ESG compliance framework.Main Responsibilities:Evaluate and develop...


  • Copenhagen, Copenhagen, Denmark Saxo Group Full time

    Regulatory Compliance Specialist - Financial CrimeSaxo Group is seeking a highly experienced Regulatory Compliance Specialist to lead our efforts in preventing financial crime and ensuring regulatory compliance worldwide.The successful candidate will have expertise in reviewing and maintaining clear policies and procedures for digital onboarding and ongoing...


  • Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

    Job SummaryNovo Nordisk A/S is seeking a Quality Assurance Professional to join its Aseptic Manufacturing Quality Assurance team. As a key member of the team, you will play a critical role in ensuring the highest quality and regulatory standards are met for our diabetes and obesity products.Key RequirementsTo succeed in this role, you will need:A master's...


  • Copenhagen, Copenhagen, Denmark Ferring Pharmaceuticals AS Full time

    Role OverviewFerring Pharmaceuticals A/S seeks a seasoned Global Regulatory Affairs Manager to lead the lifecycle projects for one of our products in the Small Molecule team.ResponsibilitiesDevelop and execute regulatory strategies for worldwide market expansions and approvals, ensuring compliance with global regulatory requirements.Collaborate with...


  • Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

    Job Description Overview">We are looking for a Quality Coordinator to drive quality-related tasks and projects across the department. The ideal candidate will have a background within science and be familiar with GMP from a production environment.This role involves coordinating and implementing changes in cross-functional quality projects and setting quality...


  • Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full time

    RequirementsTo succeed as a Senior Quality Assurance Manager at Radiometer Danmark, you will need to have the following qualifications:Education: MSc in Engineering, Pharmacy, Biology, Biochemistry or similarExperience: Profound knowledge of and experience on best practices with Quality Management System(s) within Medical Devices/DiagnosticsSkills: Min. 5...


  • Copenhagen, Copenhagen, Denmark PARETO SECURITIES AS Full time

    Company OverviewAt Continia, we develop innovative solutions to automate administrative processes for our clients. Our software is used by over 20,000 customers worldwide, and we are proud of our strong partnerships with resellers and customers.Job DescriptionThe Head of Legal and Compliance will play a crucial role in ensuring the company's adherence to...