Orion’s Research & Development, Global Development is now hiring a Senior Regulatory Affairs Manager to join our offices in Finland or the UK.

Description of position

We are looking for a Senior Regulatory Affairs Manager to lead our regulatory activities in one of our therapy areas. You will work as part of the Orion Development Regulatory Affairs Team and support development and implementation of regulatory strategy for EU licensing of Orion’s products. You will provide regulatory guidance to the product development teams and formulate regulatory strategy. Leading communications and meetings with regulatory authorities and regulatory submissions from CTA applications to marketing authorizations will also be part of your remit.

In this role you will be reporting to the Director, Development Regulatory Affairs and be a core member of the Orion Development Regulatory Affairs Team.

You can work in or travel periodically to one of our R&D offices (in UK: Nottingham, Finland: Espoo in Helsinki capital area or in Turku). Orion offers a flexible working environment which includes remote working.

Description of unit

Our Research & Development (R&D) team offers a diverse and multi-disciplinary work environment where talented individuals are ready to share our passion for the work that we do in our therapy areas (Inhaled therapies, oncology and neurological disorders). Our goal is to change the course of the disease as well as to provide significant symptomatic relief and build well-being to patients globally.

Our ambitious mission to create new treatments for the future, will require capabilities to discover and develop new medicines and treatment concepts together with our comprehensive external network of experts. To serve the future patients in the best possible way, we will strengthen our capabilities in R&D.

Global Development is accountable for all the drug development projects in inhalation, oncology, neurological disorders and animal health at Orion R&D. We are building the development portfolio strategy and programs in close collaboration with business and all R&D departments. The Development Regulatory Affairs Unit in Orion R&D, supports regulatory affairs tasks related to Orion Proprietary Products.

We offer

We offer an excellent opportunity to work in a versatile role and the possibility to make use of your own strengths within a professional team. We offer an opportunity to develop strategy, processes and opportunities to further develop your expertise in drug development. You will have a chance to make an impact on providing new treatments to patients.

Appreciation of colleagues strive for excellence and building the future are our core values. The culture at Orion R&D is informal, and we enjoy working together. Read more about Orion from the website. 

Requirements
Ideally, you should have the following qualities & former professional experience:

• BSc/PhD degree in Life Sciences or Pharmacy
• Concrete work experience in a similar regulatory affairs role in a pharmaceutical company or CRO
• A solid working knowledge and understanding of the drug development process, laws, regulations and guidelines including EU, FDA, ICH..
• Ability to assess and understand complex scientific information, regulatory precedent, competitor intelligence, and regulatory guidelines and to make recommendations based on assessment
• Experience of preparing, reviewing, compiling and submitting regulatory packages across all disciplines, including CMC, non-clinical and clinical
• Extensive experience of leading regulatory work in the EU, including CTA applications, Agency Interactions and MAAs
• A proven track record of successfully executing marketing authorisation applications through the decentralised procedure (DCP/MRP)
• Experience of regulatory activities within the inhalation therapy area, device regulations and development as related to inhalation products is an advantage 
• An understanding and experience of EU Centralised Procedure, orphan applications, PIP applications and US regulatory environment is also an advantage
• Experience in one or more of neurology, oncology or inhalation therapy areas is desirable

As the Senior Regulatory Affairs Manager, you will have the ability to manage, prioritize and efficiently execute regulatory activities and work collaboratively with teams in a dynamic environment to deliver to set deadlines. You will possess a proactive approach to problem solving and an ability to anticipate regulatory agency expectations. As you will be liaising with a multiple stakeholders, strong written and verbal communication skills are essential in order to influence and build alignment on regulatory issues. Fluency in verbal and written English is also a prerequisite.

Additional Information

For further information, please call Joanne Slee, Director, Development Regulatory Affairs, during the following times (UK): Wednesday 6th October between 14:00-16:00 or Monday 11th October between 15:00-17:00. Telephone +44-(0)7909 004768.

Please submit your cover letter and CV with your salary request by 31st October 2021 at the latest.  However, we will start interviewing possible candidates during the application time, so please ensure that we have your application as soon as possible. 

Join us – together we build well-being and do work that we are proud of!

Orion welcomes expatriate employees and their families by supporting their relocation and integration to live and work in Finland.

#LI-Remote

Approved medical examination which also includes drug testing is required prior to the employment. We will also carry out a security clearance prior to the employment for the selected person.