Celgene (Senior) Specialist, Regulatory Affairs in Munich, Germany
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Under the supervision of the Director Regulatory Affairs, Quality Management and HCC and within the framework of the global functions, this individual assists in local regulatory activities by providing relevant regulatory and technical information, assists in marketing authorisation procedures and variations and ensures compliance of Celgene products.
In this role he/she:
Ensures regulatory compliance with local legislation.
Ensures effective communication with National Health Authorities.
Supports the Regulatory Team in all operational regulatory activities on local level.
Supports Celgene International/Europe with local regulatory activities.
The differentiation of a Senior Specialist to a Specialist is based on the degree of experience, autonomy and accountability within the above mentioned role.
Responsibilities include, but are not limited to:
Marketing authorization procedures and variations
Support of Regulatory Affairs Europe in marketing authorization and variation procedures, especially regarding the product information (review of drafts and translations).
Implementation of product information changes (e.g. creation/change of print version of the SmPC, web-presentation) and maintenance of the German tracking system.
Support in executing launch activities from an operational perspective.
Updates to IFA database (notification of new products and product updates).
Support of Coordinator RA&QM with maintenance of the "Rote Liste"/"Gelbe Liste".
Informing relevant departments about changes regarding the product information.
Assistance of technical operations in creating/changing and approval of packaging components.
Maintenance of regulatory information documents (e.g. SmPC, abbreviated PI) on the Celgene webpage.
Archiving of documents electronically.
Liaison with Regulatory Affairs Europe on implementation of post authorization follow-up measures as required (e.g. PASS).
Support of all parties involved in scientific advice meetings.
Clinical Trial Applications (CTAs) where the local Affiliate is the Applicant
Support in review of country specific CTAs/amendments and creation of the cover letter.
Translation of authority correspondence.
Translation, review and approval of clinical trial labelling in local language.
Compliance of marketed products with the marketing authorisation.
Compliance with national and EU regulations and procedures.
Support in regulatory screening of the local regulatory environment, analysing the local impact and communicating relevant information internally.
Market Access Activities
Support of MACA with relevant regulatory information, timelines and clinical / regulatory documents necessary for the local benefit dossier and.
Support of Regulatory team in their collaboration with MACA.
Strong identification with Celgene’s Values.
Knowledge of local and EU regulatory requirements.
Working knowledge of the local drug regulation, relevant sections of the EU regulation, EU clinical trials directive and ICH guidelines.
Wide pharmaceutical knowledge.
Strong organizational skills with the ability to prioritize.
Must be able to work individually as well as contributing to a team.
Ability to grow and keep learning.
A strong commitment to quality and patient safety.
Must be able to appropriately handle confidential information.
Strong written and verbal German and English communication skills.
COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE