Job Description
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.
Team Lead Regulatory Affairs CMC Drug Product (gn)
As Tead Lead 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 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
- Scientific background with master degree or PhD, preferably in biology, chemistry, biochemistry or equivalent
- Minimum of 6 years work experience in Regulatory CMC area including experience with parenteral products and drug-device combination products
- Thorough knowledge of the drug development process with demonstrated experience in multiple development phases up to submission
- Excellent staff leadership and communication skills
- Fluency in written and spoken English; German knowledge would be of benefit
- Very good team player, result oriented, persistent, well organized, proactive, problem solver and able to work independently
- German work permit is mandatory
- 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!