Senior Manager, Regulatory Affairs EMEA (m/f/d)

Company Description

Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world.

Job Description

What you will do

• Develop and implement regulatory strategies for new and existing Santen products in Europe, ensuring compliance with current regulatory requirements
• Lead the preparation and submission of regulatory dossiers, manage approval processes, and provide regulatory guidance in EU development teams.
• Establish and maintain contact with national (particularly Germany and Austria) and EU regulatory bodies, and manage communications related to marketing authorizations.
• Coordinate the creation of Product Information and regulatory documents, including involvement in promotional material reviews.
• Maintain regulatory databases and develop SOPs for regulatory affairs, while contributing to international product development teams.
• Provide regulatory support for local Medical Device or Nutritional Product activities and address regulatory affairs issues in Germany.
• Assist with pricing, reimbursement issues, and other tasks as assigned by the superior.

Qualifications

What you will bring to the role

• Bachelor’s degree or higher in a life science discipline such as biology, chemistry, pharmacy, or toxicology
• Minimum of 5 years’ experience in medicinal product Regulatory Affairs in Europe, with a proven track record of success in developing, submitting, and managing regulatory submissions
• Experience working with regulatory agencies in Germany, Austria and/or Switzerland
• Ophthalmic market knowledge is a plus
• Fluency in written and spoken English and German
• Common office software skills mandatory
• Good negotiation and communication skills
• Strong teamwork and collaboration skills, with a proactive approach

Additional Information

Grow your career at Santen

A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments. 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.

Empowering Benefits await you:

• Hybrid Work Model: Get the best of both worlds with 4 days of remote working from the comfort of your own home, combined with 1 day per week in our modern office, conveniently located in the heart of Munich.
• Forge lasting connections: Work with a team of passionate, like-minded professionals who share your enthusiasm for ophthalmology. Forge meaningful connections, foster a collaborative spirit and thrive in an environment that encourages teamwork.
• Comprehensive employee benefits:
  • Benefit from our employer-funded pension scheme
  • Enjoy your time off with 30 days' leave to recharge your batteries
  • Relaxation time: Enjoy 30 days holiday plus 2 additional days off on 24.12. & 31.12. to enjoy the festive season to the full. There is also a special day off for your own birthday.

Apply now

Convinced? Then we should definitely get to know each other! We look forward to receiving your application.