Head of Regulatory Affairs CMC Drug Product (gn)

 
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.

As Head of Regulatory Affairs CMC Drug Product you will be responsible for aligning and implementing regulatory strategies for Formycon's product pipeline with regard to drug product development and manufacturing including design control aspects in the context of drug-device combination product development.

In this role you will lead a team of >= 5 RA managers. You will be acting as a regulatory expert coaching your team and aligning regulatory strategies with experts from various departments, external partners and CDMOs. Your reporting line is to the VP Regulatory Affairs and Quality Management. Your main tasks include the following:

• Align RA CMC DP strategy for Formycon's development projects and approved products (focus on aseptically manufactured parenteral products in various dosage forms) with project management, DP, device & packaging development departments and other RA CMC groups (DS and Analytics)
• Review and align strategy for essential overarching concepts with focus on DP aspects (e.g. L&E studies, combination product development including design control, process characterisation and validation studies including transport validation) and define presentation in regulatory dossiers
• Ensure timely preparation and appropriate review of regulatory documents for Briefing Books, IMPD/IND, BLA/MAA submissions and variation packages
• Establish and implement strategies for drug-device combination products during development and throughout lifecycle. Ensure that relevant regulatory requirements and guidelines are taken into account and implemented in the combination product development programs. Liaise with clinical department for design of human factor studies
• Oversee preparation of documentation packages and submission to Notified Bodies for receipt of Notified Body Opinions according to Article 117 and coordinate establishment and maintenance of design history files
• Guide RA CMC Drug Product team in defining the best strategy for each submission and their content
• Support defining response strategies for requests from authorities in close collaboration with involved SME departments and CDMOs
• Maintain knowledge of global competitive landscape, regulatory environment, and regulations with focus on drug product aspects including drug-device combination product development and design control
• Participate in meetings with regulatory agencies (e.g. EMA, FDA)
• Manage capacity allocation in team and coordinate regulatory CROs in charge of assigned work packages
• Compile and maintain budget and capacity plans

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 at recruiting@formycon.com.

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