Jobbeschreibung
As a medium-sized company based in Ladenburg near Heidelberg, we attach great importance to an open and collegial working atmosphere. We are on first-name terms, enjoy working in a team and take responsibility for our work area.
Together we are working on a new treatment approach in oncology. Based on our ADC technologies, we are developing novel drugs for the targeted and highly effective treatment of cancer. ADCs are antibody drug conjugates that combine the specificity of antibodies with the efficacy of toxins to fight cancer. We use several compounds and have built up an ADC toolbox that overcomes tumor resistance via numerous pathways and addresses different types of cancer using various antibodies. Our goal is to develop targeted and highly effective ADCs for the treatment of a variety of malignant hematologic and solid tumors.
We offer varied positions in research, development and administration. We accompany you on your personal career path and offer you a variety of opportunities to develop yourself further.
Curious? Then apply today and become part of our team!
The Global Regulatory Affairs Strategist (m/f/d) is responsible for the preparation and execution of global regulatory strategies for the assigned projects. In Detail the role is responsible for:
- Ensure the development and execution of regulatory strategy(ies) for assigned projects across all stages of development and in line with the Global Development Plan, including but not limited Clinical Trial Applications, Marketing Authorisation Applications, Scientific Advice, Applications for Orphan Drug Designations, Pediatric plans, Accelerated Pathway Designations.
- Ensure compliance with both internal processes and policies and with applicable regulatory requirements
- Provide strategic regulatory input for all development stages of the assigned projects, including study design and geographical placement, development, market access and marketing strategy.
- Represent Regulatory Affairs in Global Project Teams for assigned projects
- Lead regulatory agency interactions, including briefing document preparation, rehearsals and minutes
- Lead regulatory designation procedures, e.g. orphan applications, accelerated pathway designations.
- Review and provide regulatory input to pharmaceutical quality-related documents, safety-related documents and efficacy-related documents, (e.g. IMPD, Investigator's Brochure, Clinical Study Protocols, Clinical Study Reports and other reports).
- Support of in-licensing and out-licensing activities is nice to have
- Manage the end-to-end regulatory submission processes to approval including management and coordination of the preparation of all regulatory documentation for assigned project
- Your have a degree in Life Sciences
- Minimum of 15 year's experience in Regulatory Affairs, of which at least 10 years' regulatory development in oncology and/or hematology.
- Extensive experience as global regulatory lead in global development projects in hematology and/or oncology/immuno-oncology in at least two ICH regions
- Extensive knowledge in preparation of global regulatory strategies for New Chemical Entities (NCEs) and New Biological Entities (NBEs), ideally ADCs.
- Extensive experience in leading regulatory agency interactions and preparation of documentation to support interactions in at least two ICH regions
- Solid experience in leading a full submission/or large variation/supplement in at least one ICH region through to authorization would be nice to have
- Extensive knowledge in Clinical Trial Applications (CTA) requirements worldwide, including initial IND applications
- Proficient experience of accelerated pathway designation applications (e.g. FT, BTD, PRIME, PIM, EAMS) and designations (e.g. ODD)
- Solid knowledge of pediatric requirements, ideally experience with PIP/PSP procedures would be nice to have
- Experience with working on early development projects (FIH) in at least two ICH regions.
- Asia development experience is a plus, e.g. China and experience in co-development projects would be nice to have
- In-depth knowledge of GCP, ICH guidelines, and other relevant regulatory requirements
- Strong leadership and communication skills, with the ability to collaborate effectively across diverse teams and cultures
- Flexible working hours with compensation options and the opportunity to work remotely so that your job fits in with your life
- Mentoring program: In addition to comprehensive onboarding, you will receive a buddy who will show you everything so that you feel at home quickly
- Prospects for your personal and professional development: Benefit from our training program so that you can take your qualifications to a new level
- We support you and your family through our “FamPlus” Employee Assistance Program, e.g. in organizing childcare or caring for relatives
- We offer you a wide range of social benefits: Company pension scheme with employer subsidy, pension benefits as part of company health insurance and job bike
- Would you like to improve your fitness? No problem, then join our weekly sports club.
- You can use our free charging stations for your electric car
- Happy coffee break, weekly fruit day and regular great company events await you
Would you like to work with us today on the medicine of tomorrow for the benefit of patients? Then become part of our team!
Mehr