Senior Regulatory Scientist
4 days ago
Senior Regulatory Scientist (with Life Cycle Management focus)
We are continuing to invest in growing our business and are now seeking to hire Senior Regulatory Scientists. This role will appeal to those who are excited by the pace of change and innovation in the Life Sciences, have a passion for partnering with cutting-edge clients, and possess a strong desire to continuously learn, develop, and progress both 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
- Oversee Life Cycle Management (LCM) activities, ensuring ongoing regulatory compliance for approved products, including managing variations, renewals, and post-marketing commitments
- Provide regulatory guidance and support throughout the product lifecycle, from development to post-approval, ensuring alignment with evolving regulatory landscapes
- 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
Qualifications:
- Advanced degree in life sciences or a related field
- Minimum of 3 years of experience in regulatory affairs within the biotechnology or pharmaceutical industry
- Experience with 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, clinical trial requirements, and Life Cycle Management (LCM) activities
- 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 and continuous lifecycle management of groundbreaking products that will make a difference in patients' lives.
#J-18808-Ljbffr-
Senior Regulatory Scientist
4 days ago
København, Denmark Voisin Consulting SARL Full timeSenior 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,...
-
Senior QC Scientist
4 days 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? ...
-
Senior Upstream Scientist
4 days 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...
-
Senior Analytical Scientist
6 days ago
København, Denmark LEO Pharma Full timeSelect how often (in days) to receive an alert: Are you a passionate and experienced scientist looking for an exciting opportunity to work alongside professionals engaged in the development of topical formulations? LEO Pharma is seeking an Analytical Senior Scientist to join our dynamic team in Ballerup. You will join our Preformulation and Formulations...
-
Senior Scientist, Early Stage Development
12 hours ago
København, Denmark AGC Inc Full timeSenior Scientist, Early Stage Development Apply locations: Copenhagen, Denmark Time type: Full time Posted on: Posted 12 Days Ago Time left to apply: End Date: January 31, 2025 (9 days left to apply) Job requisition id: JR101338 Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and...
-
Global Regulatory Lead
4 days 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...
-
Scientist for the Cell Culture Team
4 days ago
København, Denmark Symphogen Full timeScientist for the Cell Culture Team (2-year temporary position) This position as upstream scientist offers a unique possibility to take part in the development of Symphogen’s antibody products. The position is in the Cell Culture team and more specifically in the part of the team that works with mammalian upstream process development. In this role you will...
-
Director of Regulatory Affairs
3 days ago
København, Denmark Black Swans Exist Full timeGet AI-powered advice on this job and more exclusive features. Senior Business Development Consultant at Black Swans Exist Director of Regulatory Affairs Are you ready to take on a pivotal role in shaping the future of women's health? Our client, a clinical-stage biotech company revolutionizing microbiome-based therapies for women's reproductive health,...
-
Senior Data Scientist
6 days ago
København, Denmark Kayak Full timeKAYAK, part of Booking Holdings (NASDAQ: BKNG), is the world’s leading travel search engine. With billions of queries across our platforms, we help people find their perfect flight, stay, rental car and vacation package. We’re also transforming business travel with a new corporate travel solution, KAYAK for Business. As an employee of KAYAK, you will be...
-
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...
-
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...
-
Quality Assurance Scientist I
4 days ago
København, Denmark AGC Inc Full timeQuality Assurance Scientist I page is loaded Quality Assurance Scientist I Apply locations Boulder, Colorado, USA time type Full time posted on Posted 8 Days Ago time left to apply End Date: January 17, 2025 (12 days left to apply) job requisition id JR100949 Our purpose is to bring hope to life by enabling life-changing therapies for patients around the...
-
Data Scientist
4 days ago
København, Denmark YO IT CONSULTING Full timePython Data Scientist/Analyst Experience: 4 - 20 Years Location: Anywhere in the World - Permanent Remote Contract Duration: 6-12 months Work Hours: 5 hours overlap with PST time zone Standard work hours are: 8 AM PST - 4 PM PST. Must-Have: Bachelor’s/Master’s degree in Engineering, Computer Science (or equivalent experience) At least 4 years of...
-
Senior Safety Data Scientist
4 days 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...
-
Preformulation Scientist/Specialist
4 days 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 days 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
4 days 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
4 days 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...
-
København, Denmark AGC Inc Full timeDownstream Process Development Scientist III/Senior Apply locations Bothell, Washington, USA time type Full time posted on Posted Today time left to apply End Date: January 31, 2025 (20 days left to apply) job requisition id JR101219 Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier...