Senior Regulatory Affairs Manager

Orion Corporation operates in more than 20 countries, where we Orionees, 3400 in total, work in all kinds of positions. Among us there are Research Scientists, Laboratory Technicians, Engineers and IT Specialists as well as people working in Production, just to mention some examples. We offer diverse and responsible jobs to our personnel in a truly multi-disciplinary work environment. We encourage people to develop their competences and offer opportunities to affect the job description and creating their own career path at Orion. We are searching for top talents who are ready to share our passion for the work that we do.
Application period ends: 2017-11-30
Unit: Orion Corporation
Location: Other
Type of employment: Fixed-term
Description of position: We are looking for a senior regulatory professional to 1-2 year temporary position to work with the specified global drug development projects. The role includes the following tasks:
- Developing global regulatory strategies and ensuring their implementation for development plans, clinical trial applications and marketing authorization applications for new NCE/NBEs and evaluation of in-licensing opportunities
- Ensuring required documentation for global regulatory submissions
- Leading communications and meetings with global regulatory authorities
- Providing regulatory support and guidance and collaborating with Orion functions (e.g. Pharmaceutical Sciences, Research, Development, Business Units)
- Collaborating with CROs and global partners
Description of unit: Orion’s pharmaceutical innovations are created within its R&D organization, including non-clinical research and clinical development. The organization employs top professionals in the field of drug development. The core therapy areas of Orion's pharmaceutical R&D are central nervous system (CNS) disorders, oncology and respiratory for which Orion develops inhaled Easyhaler® pulmonary drugs.

We have seen growth in R&D productivity over the last years and have now an exciting R&D pipeline. In order to ensure future development, we have started to build capabilities for biologics discovery. In addition we are strengthening our power in small molecule research. Experienced professionals with new competencies are needed to guarantee our continuous success.

Regulatory Product Development & Product Lifecycle Management unit is part of Global Regulatory Affairs in Orion R&D. Responsibilities of the unit relate to regulatory affairs tasks of Orion Proprietary Products and Animal Health Products.

We offer: We offer exciting opportunities to create and have an impact on future therapies for patients.
We also offer you attractive career development opportunities to use your own strengths for development. The culture of Orion R&D is informal and we enjoy working together.

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

We expect that you can work in one of our offices (R&D sites UK: Nottingham, Finland: Espoo, Turku, Kuopio)
If moving to Finland, please check the areas where Finland is considered a leader in the world by copying this link to your web browser

Requirements: We expect you to have:
- MSc/PhD decree in Life Sciences or Pharmacy
- Several years’ experience of European and US regulatory affairs in clinical development phase, wide experience in pharmaceutical industry is a benefit
- Good understanding of pharmaceutical, preclinical and clinical research with the ability to understand, analyze and present complex scientific arguments
- Experience with biologicals, biosimilars or advanced therapy medicinal products and new treatment modalities
- Excellent communication, negotiation, co-operational and team working skills in international relationships
- Fluent verbal and written English

We wish you have:
- Personal leadership and cross-functional team leadership skills
- Analytical and problem solving skills with general view and attention to details
- Proactive and open mindset for finding solutions
- Capability to think ahead to define priorities for team members
- Ability to inspire and engage others
- Hands on attitude
- Courage to think outside the box and challenge in a constructive and optimistic way
Additional information on the position: Additional information on the position: Sari Launonen, tel. +358 50966 7178 (CET +2)
Tuesday 14.11. 13-14
Thursday 23.11. 15-16
Wednesday 29.11. 12-13
In addition: Approved medical examination which also includes drug testing is required prior to the employment.
In addition: We will carry out a security clearance prior to the employment for the selected person.