As a specialized company dedicated to ophthalmology, Santen carries out research, development, marketing, and sales of pharmaceuticals, over-the-counter products, and medical devices. Santen is the market leader for prescription ophthalmic pharmaceuticals in Japan, and its products now reach patients in more than 60 countries. With scientific knowledge and organizational capabilities nurtured over a nearly 130-year history, Santen provides products and services to contribute to the well-being of patients, their loved ones and consequently to society. For more information, please visit Santen’s website (http://www.santen.eu). �

 

Regulatory Affairs Specialist

JOB’S MISSION

Maintain and obtain marketing authorisations in whole Europe for medicinal products in line with Santen strategies, business needs and European regulatory requirements. Provide expertise on regulatory processes and develop successful tactics for regulatory procedures and applications.

KEY RESPONSIBILITIES

• Independent preparation of regulatory plans and strategies for implementation of regulatory applications and responses effectively pursuing approvals in accordance with regulatory requirements and company goals. Staying up-to-date on current regulatory requirements.
• Manage regulatory lifecycle of assigned products, including maintenance of the regulatory dossiers and timely updates of regulatory database of the assigned products.
• Informing about received marketing authorization approvals and changes in-house to relevant departments via regulatory database. Informing about received marketing authorization approvals and changes to relevant external partners.
• Review and approval of secondary packaging materials to ensure compliance with regulatory approved texts.
• Cooperate with internal and external partners and authorities to maintain Marketing Authorisations.
• Inform QPPV and Safety Vigilance in case of any safety related concerns from authorities. Requesting and submission of PSUR’s and RMP’s prepared by Safety Vigilance to regulatory authorities.
• Identifying and listing/providing relevant regulatory documentation for archiving to Regulatory Operations for assigned products
• Coordinating maintenance of relevant Product Information (SmPC, labelling etc) and CCDS for assigned products together with Safety Vigilance, Medical Affairs and other related departments.
• Review and provide regulatory feedback on Change Control proposals and evaluations

COMPETENCIES

• Ability to work with computer majority of the day. Ability to learn and skills to use the IT systems in use (TrackWise, GRDS, Docubridge, Sharepoint, common office software).
• Ability to work to tight deadlines and uncertainty.
• Sufficient knowledge of the legislation of the EU and own area of responsibility regarding marketing authorization procedures and processes, focus on variations and renewals.
• Team player
• Ability and desire to work and interact with different people and functions internally and external

EXPERIENCE

Essential
• Experience on pharmaceutical industry and knowledge of medicines life cycle
• Minimum 2 years European medicinal product regulatory affairs experience
• Knowledge of the medicinal legislation of the EU and own area of responsibility regarding marketing authorization procedures and processes

Desirable
• Knowledge of medical device or food supplement regulations

EDUCATION

Essential
• Pharmaceutical, Chemical or other Life-Science university degree (B.Sc. or higher)
• Fluent written and spoken English language

Desirable
• Other European languages
• Formal studies on Regulatory Affairs

For more information:
Decennium3 Senior Consultant Mona-Maria Ilola + 358 44 383 3333.
Please send your CV and application in English latest 25th of February 2020 to:
mona-maria.ilola@decennium3.fi




MONA-MARIA ILOLA

COUNTRY MANAGER FINLAND
  •  +358443833333
  •  mona-maria.ilola@decennium3.fi