Senior Regulatory Affairs Manager / Strategic Global Regulatory Director
Orion Oyj / Orion Corporation
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 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.
Responsibilities of Global Regulatory Affairs in Orion R&D relate to regulatory affairs tasks of Orion Proprietary Products, Generic and Animal Health Products and cover whole lifecycle of the product. Generics is currently Orion’s biggest business unit and regulatory support to its activities is an important task for the organization.
Global Regulatory Affairs function consists of about 30 professionals whom work tightly with our equally sized Mumbai office, particularly related to product life cycle activities. We also have a network of local subsidiary and regulatory consultants. All together Orion regulatory affairs network comprises of almost 150 professionals throughout Orion home territory (European and EEU countries).
Description of position:
We are looking for proactive and solution orientated Regulatory Affairs professionals to provide regulatory strategies, plans and execution in critical support of Orion’s investigational and marketed prescription drug submissions and whole product lifecycle. You will apply complex global regulatory intelligence and expertise to effect innovative regulatory pathways and solutions.
We can tailor the roles to a certain extent depending on your background and experience. We can offer a leadership position if you have strong managerial experience.
The roles include the following tasks:
• Developing global regulatory strategies and ensuring their implementation for development plans, clinical trial applications, marketing authorization applications and lifecycle management for generics products and/or new NCE/NBEs
• Evaluation of in-licensing opportunities
• Ensuring required documentation for global regulatory submissions
• Networking and leading communications and meetings with global regulatory authorities
• Collaborating with other functions in Orion and providing regulatory support and guidance
• Collaborating with CROs and global partners
We expect you to have:
• MSc/PhD degree in Life Sciences, Pharmacy or Medicine
• Fluent and strong verbal and written communication skills in English language
• Solid working knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, etc. with ability to understand, analyze and present complex scientific arguments
• Courage to think outside the box and challenge the status quo in a constructive and optimistic way
• Proven leadership skills and experience is required for a managerial position
Other skills that we appreciate:
• Results-orientation, entrepreneurial and self-motivated attitude with ability and passion to learn, grow and innovate
• Ability to successfully interpret and apply regulatory intelligence to work output
• Ability to prioritize and work in a fast-paced environment and multi-task with proactive and open mindset for finding solutions
• Ability to establish close communications and working relationships with cross functional teams to meet business objectives
• Proactively managing and communicating issues, scopes, progress and risks throughout the project lifecycle ensuring key stakeholders are informed
• Ability to inspire and engage others
• Hands on attitude
We offer exciting opportunities to create and have an impact on future therapies for patients. We also offer you attractive career development and opportunities to use your own strengths. The culture of Orion R&D is informal and we enjoy working together.
The roles are located in one of our offices (R&D sites UK: Nottingham, Finland: Espoo, Helsinki capital area, Turku or Kuopio). In some cases we might consider remote work option but ideally we expect that you will work in one of our R&D sites. If moving to Finland, please check the areas where Finland is considered a leader in the world http://www.huffingtonpost.com/ira-kalb/finland-is-still-the-worl_b_10774930.html
Join us – together we build well-being and do work that we are proud of!
Additional information on the position:
Are you interested in finding out more? Minna Ruotsalainen, Vice President, Project and Portfolio Management and Regulatory Affairs will be happy to discuss with you, tel. +358 509664623(CET +1) 20th of February at 15-16, 26th of February at 11-12 and 7th of March 13-14.
- Ilmoitusnumero: 1104734
- Työsuhde: Vakituinen työsuhde
- Työn tyyppi: Kokopäiväinen
- Hakuaika päättyy: 14.3.2018
- Hakuosoite: www-osoite
- Sijainti: Avoin