Global Regulatory Affairs Specialist - København - ref. u1230719
AJ Vaccines A/S København
Global Regulatory Affairs Specialist at AJ Vaccines We Save Lives Worldwide; Would You Like to Join Us? We are looking for a specialist preferably with knowledge of CMC and regulatory life-cycle management (LCM) activities for biological products.
We invite both recently graduated or more experienced who have an interest in CMC and / or Regulatory Life Cycle Management, to apply. The Team’s Responsibilities and Ambitions Regulatory Affairs is responsible for global regulatory activities throughout the life cycle of our products in more than 50 countries worldwide.
We work closely together with our colleagues across functions and with our partners and consultants. We strive to be responsive to the worldwide business needs of AJ Vaccines A/S and to minimize time to market, while ensuring compliance in a continuously changing global regulatory environment.
You will get the opportunity to work in a team of highly competent and dedicated colleagues, who have a unique combination of scientific insight and the ability to navigate many agendas and stakeholders. Your Work Tasks As a part of Global Regulatory Affairs at AJ Vaccines A/S, you will be working with CMC and LCM activities for our biological products.
You will be engaged in the regulatory interactions concerning scientific issues with partners and Health Authorities around the world to secure sound and informed decision-making. Depending on your experience and/or interest, tasks will include: Writing, compiling, and reviewing regulatory CMC submissions in accordance with internal requirements and external regulatory guidelines and regulation.
Planning, coordinating, and executing life cycle management activities while supporting subject matter experts delivering source documents related to regulatory activities. Supporting regulatory inspections and compliance, and internal/external audits and inspections.
Commenting and approving validation and stability documentation. Execute maintenance of internal and external regulatory procedures. Support alignment of cross functional procedures. Who are You? You have a master’s degree in pharmacy, biological /chemical sciences, biomedical/mechanical engineering, or another related subject, preferred with minimum of 3 years of regulatory affairs experience or other relevant experience from the pharmaceutical industry.
You will have a great diversity of tasks in a regulatory context, which requires problem-solving, independence, understanding of complexity, creativity, and collaborative skills. You must be systematic and structured in your approach and with an analytical sense, detail-oriented and understand stakeholder and business demands with a positive mindset and constructive attitude.
When applying for this position, you are not required to add a Cover Letter, however, we welcome you to write a few lines about your motivation in your CV. At AJ Vaccines we believe in an inclusive recruitment process in which all our job applicants will be treated with an equal opportunity.
We therefore ask you to not include a photo in your CV. For further information about the position, please contact the Director of Regulatory Affairs, Hans-Henrik Kristensen at +45 2920 3336. We look forward to hearing from you! Become a part of AJ Vaccines From our headquarters in Copenhagen, we develop and manufacture vaccines, diagnostics, and therapeutic solutions for the world.
We are proud to contribute to disease control in more than 50 countries through our collaboration with WHO and UNICEF. We have more than 600 colleagues, and we pride ourselves on being a diverse workforce with passports from 37 nationalities.
Being part of AJ Vaccines means joining a common mission towards a healthier and safer world. Whether you're an experienced professional or an emerging talent, you'll find a platform here to contribute, innovate, and create meaningful change.
We invite both recently graduated or more experienced who have an interest in CMC and / or Regulatory Life Cycle Management, to apply. The Team’s Responsibilities and Ambitions Regulatory Affairs is responsible for global regulatory activities throughout the life cycle of our products in more than 50 countries worldwide.
We work closely together with our colleagues across functions and with our partners and consultants. We strive to be responsive to the worldwide business needs of AJ Vaccines A/S and to minimize time to market, while ensuring compliance in a continuously changing global regulatory environment.
You will get the opportunity to work in a team of highly competent and dedicated colleagues, who have a unique combination of scientific insight and the ability to navigate many agendas and stakeholders. Your Work Tasks As a part of Global Regulatory Affairs at AJ Vaccines A/S, you will be working with CMC and LCM activities for our biological products.
You will be engaged in the regulatory interactions concerning scientific issues with partners and Health Authorities around the world to secure sound and informed decision-making. Depending on your experience and/or interest, tasks will include: Writing, compiling, and reviewing regulatory CMC submissions in accordance with internal requirements and external regulatory guidelines and regulation.
Planning, coordinating, and executing life cycle management activities while supporting subject matter experts delivering source documents related to regulatory activities. Supporting regulatory inspections and compliance, and internal/external audits and inspections.
Commenting and approving validation and stability documentation. Execute maintenance of internal and external regulatory procedures. Support alignment of cross functional procedures. Who are You? You have a master’s degree in pharmacy, biological /chemical sciences, biomedical/mechanical engineering, or another related subject, preferred with minimum of 3 years of regulatory affairs experience or other relevant experience from the pharmaceutical industry.
You will have a great diversity of tasks in a regulatory context, which requires problem-solving, independence, understanding of complexity, creativity, and collaborative skills. You must be systematic and structured in your approach and with an analytical sense, detail-oriented and understand stakeholder and business demands with a positive mindset and constructive attitude.
You are a passionate and proactive team player, who thrives on working independently in a dynamic matrix organization in an international environment. Additionally, the successful candidate has: Knowledge of current regulatory and CMC guidelines, preferably within biologicals for human use Confident in coordination and planning task in close collaboration with stakeholders Ability to manage several tasks in parallel Good communications and collaborative skills cross functional and cross competencies Skills and interest in IT-systems and knowledge of eCTD We Offer An exciting position with a great level of variability and the possibility to affect your tasks, internal procedures, and future activities in Regulatory Affairs at AJ Vaccines A/S.
You will be an integral part of a competent and committed team with high professionalism and a fantastic team spirit. Interested? If you see yourself as a Global Regulatory Affairs Specialist at AJ Vaccines, please apply online. We will review applications and conduct interviews on an ongoing basis.When applying for this position, you are not required to add a Cover Letter, however, we welcome you to write a few lines about your motivation in your CV. At AJ Vaccines we believe in an inclusive recruitment process in which all our job applicants will be treated with an equal opportunity.
We therefore ask you to not include a photo in your CV. For further information about the position, please contact the Director of Regulatory Affairs, Hans-Henrik Kristensen at +45 2920 3336. We look forward to hearing from you! Become a part of AJ Vaccines From our headquarters in Copenhagen, we develop and manufacture vaccines, diagnostics, and therapeutic solutions for the world.
We are proud to contribute to disease control in more than 50 countries through our collaboration with WHO and UNICEF. We have more than 600 colleagues, and we pride ourselves on being a diverse workforce with passports from 37 nationalities.
Being part of AJ Vaccines means joining a common mission towards a healthier and safer world. Whether you're an experienced professional or an emerging talent, you'll find a platform here to contribute, innovate, and create meaningful change.
Application due Start dateAs soon as possible Work hours Position category Position type WorkplaceArtillerivej 5, 2300 Copenhagen S Homepagehttp://ajvaccines.com Contact Hans-Henrik Kristensen Director of Regulatory Affairs E-mail E-mail E-mail E-mail More vacant positions Follow us
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✔️ 10+ years in Regulatory Affairs, with solid experience as a consultant.
✔️ Proven expertise in Nordic and global regulatory frameworks (EMA, FDA, local authorities).
✔️ Strong consulting mindset with the ability to...
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VCLSKøbenhavn
team performance.
What You Bring
✔️ 10+ years in Regulatory Affairs, with solid experience as a consultant.
✔️ Proven expertise in Nordic and global regulatory frameworks (EMA, FDA, local authorities).
✔️ Strong consulting mindset with the ability to...