Specialist, Regulatory Affairs

What you will do

• Independent preparation of regulatory plans and strategies for implementation of regulatory applications and responses effectively pursuing approvals in accordance with regulatory requirements and company strategies and business needs. Staying up-to-date on current regulatory requirements.
• Manage regulatory lifecycle of assigned products including maintenance of the regulatory core dossiers (Mod 1-5) for territory expansions and lifecycle submissions and having an oversight of the assigned products regulatory status across EMEA. Work with Global Regulatory Lead and country leads to coordinate activities for the assigned products. 
• Maintain/ensure accuracy and timely updates of regulatory information of Marketing Authorisations of assigned products in regulatory database. Informing about received marketing authorization approvals and changes via regulatory database and to relevant stakeholders including external partners.
• Manage assigned regulatory projects and products across EMEA in collaboration with other RA teams. Support other regions coordination if product / project has scope in multiple regions. Represent regulatory affairs for the project/product in EMEA regional level crossfunctional meetings.
• Ensure compliance of secondary packaging materials with regulatory approved texts
• Cooperate with internal and external partners and authorities to pursue and maintain MAs
• Inform QPPV and Safety vigilance Unit in case of any safety related concerns from authorities. Requesting and submission of PSURs and RMPs prepared by Safety vigilance Unit to regulatory authorities.
• Maintenance of relevant Product Information (SmPC labelling etc) for assigned products together with Safety vigilance Unit Medical Affairs and other related departments (aligned with core global product information if available).
• Review and provide regulatory assessment on Change Control proposals and evaluations. Responsibility for overall regulatory implementation strategy for major changes for assigned products for EMEA.

Qualifications :

What you will bring to the role

• Pharmaceutical Chemical or other Life-Science university degree (. or higher)
• Fluent written and spoken English language
• Experience on pharmaceutical industry and knowledge of medicines life cycle
• Minimum 2 years European regulatory affairs experience
• Knowledge of the medicinal legislation of the EU and own area of responsibility regarding marketing authorization procedures and processes.
• Knowledge on one or more regulatory areas: CMC clinical non-clinical is an advantage.
• Understanding of impact of different regional requirements to product lifecycle management is desirable. 

Ready to make a difference  
Apply today and help us shape the future of eye health. 

Additional Information :

Grow your career at Santen
A career at Santen is an opportunity to make a difference. We aspire to contribute to the realization of Happiness with Vision by providing eye health products and services to patients consumers and medical professionals around the world. Guided by our CORE PRINCIPLE Tenki ni sanyo suru Santen is engaged in the global research & development manufacturing and sales and marketing of pharmaceutical products in ophthalmology. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes education and treatment. At Santen we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.

The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs role requirements and individual qualifications regardless of race color ethnicity national origin/ancestry religion sexual orientation gender gender identity/ expression age disability medical condition marital status veteran status or any other characteristic protected by law.

If you require any kind of accommodation during our recruitment process please let the recruiter from our team know.

Remote Work :

No

Employment Type :

Full-time