Senior Manager Clinical Regulatory Affairs (m/f/x) | Frankfurt | Pharma
In this position, you will ensure and create regulatory strategies and development plans with regards to new registrations and life-cycle management of the medicinal products portfolio. Additionally you will be representing the regulatory requirements in project teams, regulatory teams and other interdisciplinary teams. You will be supporting clinical development projects and compile the documentation for clinical trial applications. Moreover, you perform the submission to authorities and support the application until approval.
What will your tasks as "Senior Manager Clinical Regulatory Affairs" be?
- You coordinate regulatory projects as well as communication with the respective representatives, partners or consultants. Furthermore, you ensure, coordinate and implement a regular exchange with the relevant representatives and partners in the corresponding countries.
- You select and support in the selection of service providers and draw up contracts in cooperation with the relevant departments as well as coordinating and monitoring the services to be provided by third parties.
- You support clinical development projects with the regulatory strategy and compile the documentation for clinical trial applications. Moreover, you perform the submission to the competent authorities in the concerned countries and support the application until approval.
- You ensure and apply the regulatory knowledge for the regions /countries in the area of responsibility in order to create high-quality documentation and carry out the required registration procedures efficiently and successfully, as well as ensuring compliance with the internal requirements.
- You are responsible for the implementation of the necessary regulatory activities for the preparation and submission of applications for new registrations, approval dossiers in accordance with the respective national regulatory requirements.
- You are responsible for the creation and maintenance of the Company Core Data Sheet (CCDS) for the assigned products as well as ensuring the necessary processes. You deliver regulatory support and advice on the implementation and coordination of the CCDS implementation in local markets.
- You ensure and manage the answering of inquiries from the authorities as well as creating and supporting the creation of the corresponding reply letters in cooperation with the required specialist functions and ensuring the timely response.
- You build a detailed understanding of global and national regulatory requirements for biologicals and ensure their collection and evaluation.
- You ensure, prepare and participate in scientific consultations with regulatory authorities worldwide involving internal and external functions, as well as preparing and assisting in the preparation of background information for the authority. Another part is the cooperation with regulatory authorities in the respective countries as well as with relevant experts or opinion leaders and the support during inspection.
- You ensure and conduct the required regulatory life-cycle management activities as well as the continuous follow-up and maintenance of the submission and approval status in the regions /countries in the area of responsibility.
Your requirements as "Senior Manager Clinical Regulatory Affairs"?
- University degree in pharmacy or related scientific discipline; PhD will be an advantage
- 5 years of experience working in hands-on clinical regulatory affairs (Module 4 & 5) in a pharmaceutical environment or at a CRO
- Very good experience in clinical trial applications and registration of medicinal products in EU; additional regions are a plus
- Knowledgeable in CTD and IMPD compilation using authoring software as well as project management
- Proven ability to plan, coordinate and lead submission activities simultaneously
- Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organization
- Ability to develop and maintain good relationships, gain the trust of others, challenge views and present and argue cases in a professional and respectful manner
- Solution and detail-oriented; well-organized and self-motivated
- You are fluent in business English and have excellent communication skills, flexibility, and perseverance. Fluent Business German is an advantage
Information about our client :
Our client is a leading pharmaceuticals & medical devices companies in europe. The company is more than 100 years old and it's more than 3000 employees are operating in 50+ countries. The diverse specialties of the company include medical aesthetics and neurotoxin therapy. The company is also active in research, development and distribution of further innovative products (innovative health, wellness and beauty).
I am looking forward to you application!