Senior Regulatory Scientist
4 months ago
Senior Regulatory Scientist
We are continuing to invest in growing our Nordic business and are now seeking to hire Senior Regulatory Scientists. This role will speak to those who are excited at the pace of change and innovation in Life Science, who want have an appetite to partner the most cutting edge clients and those who want to continuously learn, develop and progress personally and professionally.
Responsibilities:
- Develop and execute regulatory strategies for assigned projects, including the preparation and submission of regulatory filings.
- Lead interactions with regulatory agencies to obtain timely approvals for clinical trials, marketing applications, and post-marketing activities.
- Evaluate and interpret relevant regulations and guidance documents to ensure regulatory compliance.
- Serve as the regulatory subject matter expert on various product development teams, providing guidance on FDA and EMA regulations, policies, and guidance documents.
- Manage and mentor junior regulatory affairs team members.
- Represent the company in discussions with external stakeholders, including industry groups, regulatory agencies, and customers.
- Advanced degree in life sciences or a related field.
- Minimum of 3 years of experience in regulatory affairs in the biotechnology or pharmaceutical industry.
- Experience of regulatory submissions and interactions with regulatory agencies.
- Knowledge of US and EU regulatory requirements for biologics and small molecules.
- Strong understanding of clinical development processes and clinical trial requirements.
- Excellent written and verbal communication skills.
- Ability to work collaboratively within a team and across functions.
- Strong strategic and analytical thinking skills.
If you are passionate about Regulatory Science and have a desire to drive innovation in the life sciences industry, we would love to hear from you. Join our team at VCLS and contribute to the development of ground breaking products that will make a difference in patients' lives.
#J-18808-Ljbffr-
Senior QC Scientist
4 months ago
København, Denmark H. Lundbeck AS Full timeSenior Quality Control Scientist, QC CMC Biologics Do you want to join our international CMC Biologics Quality Control team? And are you eager to work in an international setting where empowerment and cross functional collaboration skills are key? Then you might be our new Senior Quality Control Scientist! Your new role – why is this a great opportunity? ...
-
København, Denmark AGC Inc Full timeSenior Scientist, Late Stage Upstream Process Development Apply locations: Copenhagen, DenmarkTime type: Full timePosted on: Posted 25 Days AgoTime left to apply: End Date: December 8, 2024 (3 days left to apply)Job requisition id: JR101067 Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a...
-
Senior Upstream Scientist
3 weeks ago
København, Denmark Blackswansexist Full timeJob Description: Senior Upstream Scientist – MSAT Position Summary We are seeking a skilled Senior Upstream Scientist to join our Process Science / Manufacturing Science and Technology (MSAT) team. In this critical role, you will act as a subject matter expert in cell culture processes, ensuring the successful introduction, transfer, and implementation...
-
Global Regulatory Lead
4 months ago
København, Denmark Ferring Pharmaceuticals AS Full timeAre you an experienced Regulatory Affairs Professional, and do you want to help drive the development of the current and next generations of Ferring’s health care solutions that help people live better lives? Then come join us in a challenging position in one of our Global Regulatory Affairs Therapeutic Area teams. Ferring is dedicated to advancing...
-
Senior Data Scientist
3 weeks ago
København, Denmark Carlsberg Group Full timeLocation: Copenhagen, DK Entity / company: Integrated Information Technology (IIT) Senior Data Scientist We are seeking a skilled data scientist to define Carlsberg's data science strategy and lead the creation of advanced analytics and machine learning models to address intricate business challenges at Carlsberg. Great beers, great colleagues, a focus on...
-
Senior Director, Regulatory Affairs Strategy-EU/RoW
4 months ago
København, Denmark Genmab AS Full timeSenior Director, Regulatory Affairs Strategy-EU/RoW At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is...
-
Senior Director, Regulatory Affairs Strategy-EU/RoW
4 months ago
København, Denmark Genmab Full timeAt Genmab, we’re committed to building extra(not)ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in...
-
Senior Safety Data Scientist
4 months ago
København, Denmark Lundbeck AS, H Full timeYour experience with data science might be just what we’re looking for. You can be part of transformational initiatives that will impact the field of patient safety. Your enthusiasm for providing data-based insights will help us progress our understanding of the safety of our products for the benefit of patients. Your skillset and contributions will enable...
-
København, Denmark Danske Bank Full timeWould you like to be a significant contributor to the implementation and execution of an effective 1st LoD controls management framework in Danske Bank? And would you like to work closely with the business in testing their key controls to ensure robust business processes - and keep Danske Bank and its customers out of harm? We are looking for a Senior Risk...
-
Preformulation Scientist/Specialist
4 months ago
København, Denmark H. Lundbeck AS Full timePreformulation scientist/specialist, Pharmaceutical Development small molecules Lundbeck’s passion is tied to our goal of restoring healthy mental well-being, so that every person can be their best. We strive to make a real difference for patients by developing innovative treatments that improve the lives of people living with brain diseases. We are...
-
Senior Safety Data Scientist
4 months ago
København, Denmark H. Lundbeck AS Full timeYour experience with data science might be just what we’re looking for. You can be part of transformational initiatives that will impact the field of patient safety. Your enthusiasm for providing data-based insights will help us progress our understanding of the safety of our products for the benefit of patients. Your skillset and contributions will...
-
København, Denmark Chr. Hansen Holding AS Full timeCareer Opportunities: Senior Application Scientist for Fresh Dairy Enzyme Application (10817) Requisition ID: 10817 - Posted: Others - Permanent - Fulltime - Country (1) - Location (1) Our purpose points the way In Novonesis, we know that solutions rooted in biology can help solve humanity’s biggest challenges. Since we began more than a century ago,...
-
Data Scientist
2 months ago
København, Denmark Acceleration WPP Group Full timeJoin a growing team of Data Scientists transforming marketing for some of the world's largest brands! Join a team of expert Data Scientists and Consultants at Choreograph, a GroupM company, revolutionizing marketing for the world's biggest brands. We transform data into powerful solutions for complex media and marketing challenges, leveraging cutting-edge...
-
Data Scientist
2 months ago
København, Denmark Acceleration WPP Group Full timeJoin a growing team of Data Scientists transforming marketing for some of the world's largest brands! Join a team of expert Data Scientists and Consultants at Choreograph, a GroupM company, revolutionizing marketing for the world's biggest brands. We transform data into powerful solutions for complex media and marketing challenges, leveraging cutting-edge...
-
Global Regulatory Affairs Manager – CMC
4 months ago
København, Denmark Ferring Pharmaceuticals AS Full timeWould you like to join an international company with excellent development opportunities and an open work environment where your contributions will make a difference, as you take on CMC responsibility for one of our products and a development project? You will be part of our Small Molecule team, which is responsible for all global regulatory CMC activities...
-
København, Denmark Genmab Full timeAt Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being...
-
Data Scientist
2 months ago
København, Denmark Group M Worldwide Inc. Full timeJoin a growing team of Data Scientists transforming marketing for some of the world's largest brands! Join a team of expert Data Scientists and Consultants at Choreograph, a GroupM company, revolutionizing marketing for the world's biggest brands. We transform data into powerful solutions for complex media and marketing challenges, leveraging cutting-edge...
-
Data Scientist
4 months ago
København, Denmark Twoday AS Full timeVi er twoday, en international virksomhed med mere end 2.700 mennesker, der ønsker at gøre en forskel. Hver dag udvikler vi virkelig nyttige løsninger, der gør folks dagligdag lidt lettere. Apply here twoday er den førende digitale transformationspartner i Nordeuropa med en global tilstedeværelse. Med cirka 3.000 teknologer samarbejder vi med de mest...
-
København, Denmark Københavns Universitet Full timeThe University uses third-party technologies to register user behaviour on the website (statistics) to keep improving our service. The University also uses third-party technologies to promote degree programmes, courses, conferences and exhibitions on websites and social media to show you the most relevant offers. Staff Scientist at Department of Biomedical...
-
Senior Clinical Research Scientist, Solid Tumor Team
4 months ago
København, Denmark Genmab Full timeAt Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being...