Principal Regulatory Affairs Professional/Global regulatory CMC Lead
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Hørsholm
ALK is on an ambitious journey to become the preferred allergy company globally and therefore we are looking for a new colleague to join us.
The position
Are you dedicated to Regulatory Affairs? Are you dedicated to communication of complex scientific matters in a written form? Do you have experience with requirements for biological products and Regulatory Life Cycle Management of medicinal products globally? Do you enjoy cross-functional interactions? Are you an ambitious team player?
Then you might be our new colleague in the open position as Global Regulatory CMC Lead in Global Regulatory Affairs (GRA). The open position is placed in the Injectables, Drops & Devices Team which is part of the Regulatory CMC department. The position is in Hørsholm, Denmark.
Fields of responsibility
Your qualifications
The department/team
In the Injectables, Drops & Devices team we are 10 passionate experienced colleagues. We always try to develop our competences and processes in order to the meet the needs of the patients and all stakeholders, internally as well as externally. We are driven by a high level of professionalism, integrity, an open-minded approach and contributing to an inspiring and fun working environment together with colleagues.
We Offer
In Global Regulatory Affairs, we provide an attractive working environment for Regulatory Affairs Professionals looking for both personal and professional development.
ALK provides a uniquely dynamic and pleasant working environment, with inspiring and challenging assignments. The results of your efforts will be significant throughout the organization and you will be able to actively influence and challenge the status quo. Our flat structures attract independent individuals who like to feel the progress of the business and enjoy being close to the decision-making process. You will be part of an engaged and informal team who values skills and knowledge creation. We consider our pioneering spirit coupled with our trustworthiness our winning formula.
Allergy Solutions For Life
More than 500 million people worldwide have allergies. Many of them suffer in silence because the way ahead is too confusing.
By collecting information and the latest and most trusted solutions together in one place, we want to make allergy surprisingly simple to manage. With 100 years of experience, nobody knows allergy like us, and we continuously apply our scientific knowledge and expertise to help people take control of their allergy and their life.
We want to make a difference by offering solutions for everyone who is touched by allergy – through a comprehensive range of products, services and resources that offer a fast-track to a more balanced life.
By joining ALK you will get the opportunity to be part of our exciting journey where you are able to create results, develop solutions, yourself and ALK together with highly skilled and engaged colleagues while helping millions of people suffering with allergy.
If this sounds like a mission you would like to be part of accomplishing, we hope to receive your CV and application no later than 18th of September 2020. We will call in for interviews continuously.
Contact
For further information on the position please contact Senior Director Stig Grell (+45 41 29 07 05).
The position
Are you dedicated to Regulatory Affairs? Are you dedicated to communication of complex scientific matters in a written form? Do you have experience with requirements for biological products and Regulatory Life Cycle Management of medicinal products globally? Do you enjoy cross-functional interactions? Are you an ambitious team player?
Then you might be our new colleague in the open position as Global Regulatory CMC Lead in Global Regulatory Affairs (GRA). The open position is placed in the Injectables, Drops & Devices Team which is part of the Regulatory CMC department. The position is in Hørsholm, Denmark.
Fields of responsibility
- Global regulatory CMC Lead for an Allergy Immune Therapy product
- Provide regulatory guidance in cross-functional teams related to product optimization and strategic expansion
- Establish the optimal regulatory CMC strategies for Life Cycle Management (LCM) submissions
- Lead CMC submissions including writing and maintaining CMC part of regulatory dossiers
- Ensure overview of submitted and approved CMC documentation in different countries
- Monitor global regulatory requirements related to biological products
Your qualifications
- A Master of Science degree, e.g. in pharmacy, engineering or other relevant discipline
- Experience with regulatory LCM CMC activities in the pharmaceutical industry
- Experience with regulatory CMC requirements for biological products
- Ability to establish regulatory strategies and define appropriate documentation level
- Thrive with scientific discussions with the goal of clarifying needs and identifying solutions
- Open towards other departments and external stakeholders
- Enjoy preparing clear and logically organised written material on complex scientific matters
- Excellent English communication skills, both in writing and orally
- Value teamwork and prefer meeting challenges as a team
- Takes responsibility for having the job done
- Result oriented and able to keep the perspective in times of high workload
The department/team
In the Injectables, Drops & Devices team we are 10 passionate experienced colleagues. We always try to develop our competences and processes in order to the meet the needs of the patients and all stakeholders, internally as well as externally. We are driven by a high level of professionalism, integrity, an open-minded approach and contributing to an inspiring and fun working environment together with colleagues.
We Offer
- An exciting and challenging job with your own areas of responsibilities
- Good opportunities for personal as well as professional development
- A dynamic work environment with highly motivated colleagues and a strong team spirit
In Global Regulatory Affairs, we provide an attractive working environment for Regulatory Affairs Professionals looking for both personal and professional development.
ALK provides a uniquely dynamic and pleasant working environment, with inspiring and challenging assignments. The results of your efforts will be significant throughout the organization and you will be able to actively influence and challenge the status quo. Our flat structures attract independent individuals who like to feel the progress of the business and enjoy being close to the decision-making process. You will be part of an engaged and informal team who values skills and knowledge creation. We consider our pioneering spirit coupled with our trustworthiness our winning formula.
Allergy Solutions For Life
More than 500 million people worldwide have allergies. Many of them suffer in silence because the way ahead is too confusing.
By collecting information and the latest and most trusted solutions together in one place, we want to make allergy surprisingly simple to manage. With 100 years of experience, nobody knows allergy like us, and we continuously apply our scientific knowledge and expertise to help people take control of their allergy and their life.
We want to make a difference by offering solutions for everyone who is touched by allergy – through a comprehensive range of products, services and resources that offer a fast-track to a more balanced life.
By joining ALK you will get the opportunity to be part of our exciting journey where you are able to create results, develop solutions, yourself and ALK together with highly skilled and engaged colleagues while helping millions of people suffering with allergy.
If this sounds like a mission you would like to be part of accomplishing, we hope to receive your CV and application no later than 18th of September 2020. We will call in for interviews continuously.
Contact
For further information on the position please contact Senior Director Stig Grell (+45 41 29 07 05).
Information og data
Denne ledige stilling har jobtypen "Laborant", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Hørsholm.
Jobbet er oprettet på vores service den 3.9.2020, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Laborant
- Hørsholm
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