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Location

Bad Vilbel | Germany

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Job description

"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:   

Senior Regulatory Manager Global Specialty / Biosimilar Development (f/m/d)

Bad Vilbel | Germany (DE) | Full-time | Permanent 

What you can expect

• You are the accountable regulatory lead for one or more Global Biosimilar and/or Specialty Programs covering program activities along entire product life cycle.
• You define the strategy and the management of centralized/international marketing authorization applications for biosimilars/specialties
• You are responsible for the Due Diligence of external development projects, data intelligence, medical products
• You are an active part of the Global Biosimilars and Specialty Team and agile engagement with related departments
• You are undertaking the re-approval/marketing authorization application (MAA): authoring, revision, review of IMPDs, briefing documents for scientific advice/pre-submission/Co-Rapporteur meetings, clinical and quality dossier sections, response documents, administrative documents (Module 1)
• You are supporting the launch preparation and post-approval life cycle management and maintenance activities
• You are responsible for the Authoring, revision, review of variations, renewals, PSURs, change notifications, dossier sections, HA question/response documents, administrative documents, CMC-RA/Submission strategy, technical preparation of submission.
• You are responsible for the Management of product information texts (folding boxes, labels, SmPC, patient information leaflet, patient websites) including translations.
• You are overtaking tasks of Regulatory Compliance eg. The Oversight of regulatory relevant activities and assurance of regulatory compliance.

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 have 8+ years experience working in the life science sector
• You are experienced with FDA and Regulatory Affairs in other non-EU countries
• You are expereinced with medical devices and the EU Regulation
• You are experienced with regulatory intelligence software, publishing tools and document management software is a plus
• You have the ability to interpret and apply regulations to the specific project
• You have strong communication skills, proactive team worker, high sense of responsibility and good problem solving and organizational skills
• You have excellent knowledge of English is required, German and additional language is a plus

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 group accident insurance or supplementary pension scheme
• Subsidized cafeteria

We look forward to receiving your application via our  career portal . At jobs.stada.com 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 [email protected]

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.  #LI-NS1 #LI-HYBRID

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