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Description of position:
The regulatory function in R&D supports Rx generics and OTC products across multiple therapeutic areas and product types. This dynamic group is now looking to recruit an experienced senior RA Manager to focus our generic portfolio both in Rx and OTC. The preferred candidate will have strong experience in Rx and OTC medicines and a broad range of regulatory experience across all EU procedures. The preferred candidate will thrive on an environment in which cross-functional teams deliver regulatory goals across multiple products. The position will suit a candidate who enjoys bringing innovative solutions to the complex challenges associated with generic Rx and OTC portfolio including strategy development. In return we offer a competitive package and great working environment with helicopter view to company’s generic product portfolio.
Role Description:
•To provide full regulatory support to generic Rx and OTC projects from feasibility assessment through to post-approval lifecycle management.
•Development of innovative regulatory strategies.
•To create and manage submissions of high quality applications for new and legacy Rx and OTC applications in the EU region and some cases in CIS.
•Develop /Co-ordinate development of high quality regulatory dossiers for new generic Rx and non-prescription products in close cooperation with Partners, Global Sales, R&D, Medical & Safety, Business Unit.
•Ensure new licenses/approvals are obtained in a timely manner, negotiating with partners and agencies where necessary also during LCM phase to obtain best possible outcome for business.
•Monitoring, interpretation, communication and implementation of new EU legislation with particular focus on generic Rx and OTC portfolio
•To ensure that GxP practices, regulatory procedures, systems and processes are managed in compliance with all relevant corporate quality standards.
Requirements:
•Knowledge of European regulatory legislation, guidance and procedures for medicinal products, with specific experience in generic Rx and OTC reclassification procedures desirable
•Commercial awareness of the pharmaceutical/OTC business
•Knowledge and development of regulatory strategies & proven experience of successful interaction/negotiation with Regulatory Agencies when working at generic company or experience from the regulatory agency side is appreciated
•Strong experience in Regulatory Affairs, in particular generic Rx and OTC applications and life cycle management
• A can-do attitude and use your communication skills to build relationships and convey complex information.
Educational Background
• Degree level education (preferably science based e.g. pharmacy, chemistry or related subject)
Orion’s mission is to build well-being. At Orion Corporation are live according our values (Mutual trust and respect, Customer focus, Innovation, Achievement, Quality, reliability and safety) and provide solution to our customers.
Please note – We are open to consider different option for the contract depending your personal life situation. (Fixed term or permanent, Full time/part time). We prefer that you can work at least part time in one of our offices (R&D sites UK: Nottingham, India: Mumbai, Finland: Espoo, Turku, Kuopio)
The first round of interviews will be made via video.
Additional information on the position:
Minna Ruotsalainen, Director, Project and Portfolio Mgnt & RA Platform, tel. +358 50 966 4623
Apply here: https://express.candarine.com/campai...d/46cf4a3b3c44
The regulatory function in R&D supports Rx generics and OTC products across multiple therapeutic areas and product types. This dynamic group is now looking to recruit an experienced senior RA Manager to focus our generic portfolio both in Rx and OTC. The preferred candidate will have strong experience in Rx and OTC medicines and a broad range of regulatory experience across all EU procedures. The preferred candidate will thrive on an environment in which cross-functional teams deliver regulatory goals across multiple products. The position will suit a candidate who enjoys bringing innovative solutions to the complex challenges associated with generic Rx and OTC portfolio including strategy development. In return we offer a competitive package and great working environment with helicopter view to company’s generic product portfolio.
Role Description:
•To provide full regulatory support to generic Rx and OTC projects from feasibility assessment through to post-approval lifecycle management.
•Development of innovative regulatory strategies.
•To create and manage submissions of high quality applications for new and legacy Rx and OTC applications in the EU region and some cases in CIS.
•Develop /Co-ordinate development of high quality regulatory dossiers for new generic Rx and non-prescription products in close cooperation with Partners, Global Sales, R&D, Medical & Safety, Business Unit.
•Ensure new licenses/approvals are obtained in a timely manner, negotiating with partners and agencies where necessary also during LCM phase to obtain best possible outcome for business.
•Monitoring, interpretation, communication and implementation of new EU legislation with particular focus on generic Rx and OTC portfolio
•To ensure that GxP practices, regulatory procedures, systems and processes are managed in compliance with all relevant corporate quality standards.
Requirements:
•Knowledge of European regulatory legislation, guidance and procedures for medicinal products, with specific experience in generic Rx and OTC reclassification procedures desirable
•Commercial awareness of the pharmaceutical/OTC business
•Knowledge and development of regulatory strategies & proven experience of successful interaction/negotiation with Regulatory Agencies when working at generic company or experience from the regulatory agency side is appreciated
•Strong experience in Regulatory Affairs, in particular generic Rx and OTC applications and life cycle management
• A can-do attitude and use your communication skills to build relationships and convey complex information.
Educational Background
• Degree level education (preferably science based e.g. pharmacy, chemistry or related subject)
Orion’s mission is to build well-being. At Orion Corporation are live according our values (Mutual trust and respect, Customer focus, Innovation, Achievement, Quality, reliability and safety) and provide solution to our customers.
Please note – We are open to consider different option for the contract depending your personal life situation. (Fixed term or permanent, Full time/part time). We prefer that you can work at least part time in one of our offices (R&D sites UK: Nottingham, India: Mumbai, Finland: Espoo, Turku, Kuopio)
The first round of interviews will be made via video.
Additional information on the position:
Minna Ruotsalainen, Director, Project and Portfolio Mgnt & RA Platform, tel. +358 50 966 4623
Apply here: https://express.candarine.com/campai...d/46cf4a3b3c44