Manager Regulatory Affairs Global Specialty

"Caring for People's Health as a Trusted Partner" - This mission motivates us at STADA every day to improve the health of people worldwide. With our wide range of generics, consumer health products and specialty pharmaceuticals, we offer patients, doctors and pharmacists a wide range of therapeutic options.

Around 13,000 employees live our values of Integrity, Entrepreneurship, Agility and One STADA. Together we are on an exciting growth journey and want to successfully shape the future of STADA.

Do you want to become part of a dynamic, international team and grow with us? Then apply now as:

Manager Regulatory Affairs Global Specialty / Biosimilar Development (f/m/d)
Bad Vilbel | Germany (DE) | Full-time | Fix-term | Portfolio & Product Development

What You Can Expect

• You are responsible for the lifecycle management and maintenance of an entire biosimilar project
• You handle post-approval changes and submissions (lifecycle management) and prepare administrative documents such as cover letters, tracking tables, and application forms
• You process dossier documents using document management software and generate eCTD sequences with publishing software
• You initiate change control processes for variations and maintain entries in the regulatory information management system (RIMS), including tracking procedures and xEVMPD submissions
• You organise project trackers for marketing authorisation and variation procedures, and keep external partners and affiliates informed about the status of regulatory procedures
• You compare dossiers between EU and non-EU countries and maintain product information (PI) in 25 EU languages
• You update product information in accordance with reference product text and QRD requirements, and coordinate the translation of PI texts for authorisation and variation procedures
• You request certificates and prepare statements for external partners
• You review artworks and ensure their compliance with EMA-approved mock-ups and EC guidelines
• You contribute to continuous improvement initiatives within the department and jointly lead the revision of existing internal processes to develop optimisation proposals

Who We Are Looking For

• You hold a Degree in life sciences (master in pharmacy, chemistry, biology, biotechnology or related discipline), a PhD or MBA is a plus
• You have a professional experience in Global Regulatory Affairs for Biologics and/or Small Molecules (clinical, registration or lifecycle)
• You are experienced with FDA and Regulatory Affairs in other non-EU countries
• You are expereinced with medical devices and the EU Regulation
• You have excellent knowledge of English is required, German and additional language is a plus
• The position is to be filled until 30 September 2027

What We Offer

• An open corporate culture with fast decision-making processes and a lot of potential for your personal development
• Individual development and training opportunities
• Flexible working hours and mobile working up to 2 days per week (depending on the job profile)
• Job ticket for the RMV region and Job Bike
• Childcare allowance
• Health-promoting offers such as Wellpass or the STADA Gym (free of charge)
• Numerous additional benefits such as "future payment", group accident insurance, supplementary pension scheme, and chemical industry pension fund
• Subsidized cafeteria

We look forward to receiving your application via our career portal . At you will also find numerous other job opportunities, as we are always looking for motivated talents who can strengthen our team with their expertise and personality. Do you have further questions? Then please reach out to . Part-time requests are considered on an individual basis.

STADA Group promotes its diverse culture, regardless of gender, age, social or ethnic origin, disabilities, religion, ideology or sexual orientation. We use the strength of this diversity to develop creative ideas, expand our experience and increase innovative strength. Our focus is on equal opportunities, respectful cooperation and the promotion of an inclusive working environment.