Formycon is an international leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. With an experienced team comprised of around 240 highly skilled professionals, the company is able to span the entire value chain of biosimilar drug development, from market analysis and target definition by protein analytics, to the development of production processes, to clinical trials and the regulatory approval process.

Our focus is on treatments in ophthalmology and immunology as well as for other key chronic diseases. Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines.

To support our team in Martinsried near Munich, we are looking for suitable candidates for this full-time and permanent position, to begin work as soon as possible.

Senior Manager Regulatory Affairs CMC Analytics (gn)

Your responsibilities

As Senior Manager Regulatory Affairs CMC Analytics (gn) you will take a leading role in coordination and execution of regulatory CMC activities for dedicated Formycon’s biosimilar and NBE development programs with the focus on analytics. This includes but is not limited to the following tasks:

Planning, writing and compilation of regulatory documents with focus on CMC documentation for analytical development programs (e.g. characterization studies, analytical similarity/comparability studies, method qualification/validation studies) including lifecycle activities
Coordination of regulatory activities with involved stakeholders (e.g. internal functional departments, external CMOs/CROs, license partners)
Development and implementation of CMC regulatory strategies during product development and throughout lifecycle. Ensuring that relevant regulatory requirements and guidelines are considered and implemented in the development programs
Participation in technical project teams and point of contact for external partners and CMOs/CROs for regulatory topics
Review and approval of documents/plans/reports from CMOs/CROs and internal functional departments
Leading discussions internally and with external partners and participation in health authority meetings
Providing professional guidance and coordinating project support from colleagues/consultants

Your qualifications

Scientific background with master’s degree or PhD preferably in biotechnology, biochemistry, biology or equivalent
Minimum five years of experience in regulatory CMC area
Experience in regulatory CMC requirements for biological products, ideally with focus on analytical aspects
Practical experience in compilation of CMC documentation for IMPD/IND, BLA/MAA for biotech products
Experience with biosimilars and knowledge of corresponding EMA/FDA guideline requirements would be of advantage
Very strong matrix leadership and communication skills
Excellent team-player, able to coordinate, prioritize and manage a variety of tasks and issues, proactive and result-oriented, able to work independently
Creativity and enthusiasm for working in a dynamic fast-growing biopharmaceutical company
Fluency in written and spoken English
Proficiency in MS-Office
German work permit is mandatory

We offer

Flexible working time
Hybrid work
30 days paid vacation
Formycon pension
Group accident insurance
Formycon card
Continuing education offers
Team spirit, great working atmosphere and much more!

Bring us your skills and energy, and shape your own career in a stimulating and open work environment. We are looking for highly motivated individuals who are ready to take on new challenges with enthusiasm and personal commitment. Working at Formycon means being part of a smart, innovative team with minimal hierarchy and opportunity to share your own ideas.

Have we sparked your interest? Then we look forward to receiving your application for employment through our online application portal. Please be sure to include all supporting documents, along with your earliest possible starting date and your salary expectations. We look forward to learning about you and the qualifications which you would bring to this position.

For any questions, please feel free to send us an email.

Apply now

Full-Time , Permanent

Specialist

Updated at 12/04/2024

While applying for the job please refer to jobvector