Senior Principal Regulatory Specialist, ALK / 1852
ALK helps people living with allergy. By providing solutions that make life with allergy surprisingly simple they make a difference for millions of people. The company builds upon a strong heritage as a pioneer in allergy immunotherapy and they will continue to innovate, develop, and market new products and solutions for people with allergy. ALK is a global company with production sites in Denmark, France, Spain, and the United States. They were founded in Copenhagen in 1923 and today ALK employs around 2,600 people around the globe. Headquarter is based in Hørsholm north of Copenhagen. ALK knows that their employees are their most asset, and they believe they do their very best every day in the pursuit of new and better allergy treatments and solutions for people with allergy around the world. If you like to have influence and make a difference ALK is the right place, so come join them on their exciting journey. The HQ is placed in Hørsholm. See more at www.alk.dk
Global regulatory affairs (GRA) consist of approx. 60 talented people working with regulatory strategies worldwide for the global portfolio. Tablet New Generations (TNG) consist of a small, engaged team of 10 colleagues working with regulatory clinical, nonclinical, and procedural activities for projects related to the 4 sublingual immunotherapy tablets on the market, and a new tablet treating peanut allergy, which is in phase 1. The communication will be open, honest, and direct and one of the core values in the team is “your success equals success of the team”. The working environment is characterized by strong team-work, room for individual performance and development, informality and respect, high work-ethics, en-gagement, and fun. You can be part of this exciting journey.
Senior Principal Regulatory Specialist
You are a true Team Player
- Making a real difference in people’s lives within allergy
- Global RA Lead for clinical development projects
- You are a skilled Regulatory Professional, who want to excel
Are you willing to challenge the status quo and embark on a transformational journey in a pharma company with an ambitious growth target in the years to come? Do you like strategy while keeping an eye on operational excellence? Do you have solid experience in working within Regulatory Affairs?
You will be joining colleagues that are highly skilled and have vast experience in their field of expertise.
As Senior Principal Regulatory Specialist, you will be given a range of responsibilities within regulatory clinical, nonclinical, and procedural activities. You will be Global Regulatory Lead for a development project within food allergy, were ALK need your regulatory expertise with FDA, Health Canada, EU, and UK.
The Team value a high level of trust and support which was shown in the latest engagement survey, where the team had a peer relationship score on 9,8 out of 10. You will get highly rewarded for the absent of ego, focusing on teamwork and making brilliant results together with your team.
Fields of responsibility
- Global Regulatory Lead for a development project within food allergy
- Provide guidance and develop global regulatory strategies
- Establish, compile, and coordinate the administrative, nonclinical, and clinical part of ALK regulatory sub-missions including Scientific Advice with EMA, national CA, FDA, PIP/iPSP, IND amendments
- Collaborate with stakeholders both in and outside Global Regulatory Affairs on strategies for clinical and procedural regulatory activities
- Regulatory core team member and trial team member
- Being up to date with regional regulations and guidelines
ALK provides a dynamic and very pleasant work environment, complete 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. The flat structures attract independent individuals who like to feel the progress of the business and enjoy being close to the decision-making. ALK consider their pioneering spirit coupled with their trustworthiness to be their winning formula. ALK is a health focused organization, and their offices offer a green view of the DTU Science Park in Hørsholm. You will report to the Director, Regulatory Affairs.
We highly value your experiences and skills, but most importantly your personality. You have a structural approach and a collaborative nature. You are proactive, positive and a profound team player.
You have a Life Sciences degree within pharmacy, chemistry, biochemistry, pharmaceutical sciences, or another relevant field and at least 6+ years of experience from the Pharmaceutical Industry. You have a proven track record of working with development projects in a global regulatory affairs department. You have excellent skills and experience working with US FDA, Health Canada, and European authorities.
As a person you are a well-balanced and pragmatic, who see solutions instead of problems, as the communication in the team will be open, honest, and direct with respect for each other’s skills and expertise.
You are motivated by working in a dynamic environment, keeping calm and finding the essential elements in an often-unpredicted high pace environment. You have of cause excellent written and verbal communication skills in English.
Best Talent is responsible for the recruitment process for this position at ALK and review your application on a confidential basis. Forward your application including your CV attention 1852/RA Lead” by way of e-mail to firstname.lastname@example.org. You can read more about Best Talent at www.besttalent.dk.