Director, Regulatory Affairs, Europe (Oncology)

Job Location: Windsor, Berkshire, England, United Kingdom

Job Code: F8213

Job Salary Package: Highly competitive salary, car, bonus and full benefits package

Liftstream is recruiting for this pivotal job in the European Regulatory Affairs group of Celgene. In this managerial position you will lead an experienced and highly qualified group of regulatory professionals in developing products in the oncology/haematology franchise, as well as taking ownership for some of the companies key marketed products.

Liftstream is seeking to engage with experienced European regulatory professionals that can demonstrate extensive experience of European drug development regulatory affairs and who can contribute their therapeutic experience of oncology or haematolog to this group. We would also be very interested to consider established experience in the biologics arena.

Responsibilities will include, but are not limited to, the following:

• Act as European Regulatory Lead and provide strategic input on the European regulatory strategy to global project teams in all phases of drug development.

• Prepare European regulatory strategy plans to provide guidance on EU regulatory requirements for product registration and for achieving an acceptable labeling in EU markets.

• Serve as the lead Regulatory person and provide interface for EMEA and other regulatory authorities for assigned projects in the region

• Prepare and provide input to scientific content of Clinical Trial Application (CTA) documents and provide guidance for submission to EudraCT and local European health authorities in collaboration with Regulatory Operations.

• Lead the preparation of European regulatory submissions (e.g., scientific advice requests, orphan drug applications, Marketing Authorisation Applications, variations) in collaboration with other disciplines and manage these regulatory procedures

• Identify issues that will impact programs and provide strategies for dealing with them.

• Provide advice to marketing group on labeling issues.

• Act as regulatory representative on various cross-functional teams both regionally and globally and support Global Regulatory Affairs Leader for assigned projects.

• Interface between Headquarters and European Affiliates to keep Affiliates updated on regulatory projects and issues arisen with their respective Health Authorities

• Participates in Business Development efforts, if assigned.

• Manage team of regulatory professionals and ensure development plans are in place for all staff, where assigned.

Skills/Knowledge Required:

Bachelors degree in scientific discipline; Advanced scientific degree preferred; Experience in Haematology/Oncology Drug Development required.
Extensive experience in the pharmaceutical industry, (to include considerable period in regulatory affairs). Global experience highly desirable.
Thorough knowledge of the drug development process, especially in oncology or haematology.
Specific expert knowledge in one or more key areas- Drug Development/CMC/Pharmtox/Biopharmaceutics/Clinical/Promotion
Inter-dependant partnering skills, team-orientated and demonstrated ability to influence outcomes are necessary skills in the environment.
Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.
Must be able to innovate, analyze and solve problems with minimal supervision and attention to detail
International travel will be necessary

If you would be interested in exploring this particular job opportunity (F8213) with Ceglene, then contact Liftstream by either applying for the role via the online registration process or telephone us for a confidential and informative discussion. If contacting us during working hours is difficult, please feel free to email us on celgene@liftstream.com with your questions or to request an out of hours time to speak with our consultants.


Organisation Relationships Innovation Growth Environment Jobs Celgene	Director, Regulatory Affairs, Europe (Oncology) Job Location: Windsor, Berkshire, England, United Kingdom Job Code: F8213 Job Salary Package: Highly competitive salary, car, bonus and full benefits package Liftstream is recruiting for this pivotal job in the European Regulatory Affairs group of Celgene. In this managerial position you will lead an experienced and highly qualified group of regulatory professionals in developing products in the oncology/haematology franchise, as well as taking ownership for some of the companies key marketed products. Liftstream is seeking to engage with experienced European regulatory professionals that can demonstrate extensive experience of European drug development regulatory affairs and who can contribute their therapeutic experience of oncology or haematolog to this group. We would also be very interested to consider established experience in the biologics arena. Responsibilities will include, but are not limited to, the following: • Act as European Regulatory Lead and provide strategic input on the European regulatory strategy to global project teams in all phases of drug development. • Prepare European regulatory strategy plans to provide guidance on EU regulatory requirements for product registration and for achieving an acceptable labeling in EU markets. • Serve as the lead Regulatory person and provide interface for EMEA and other regulatory authorities for assigned projects in the region • Prepare and provide input to scientific content of Clinical Trial Application (CTA) documents and provide guidance for submission to EudraCT and local European health authorities in collaboration with Regulatory Operations. • Lead the preparation of European regulatory submissions (e.g., scientific advice requests, orphan drug applications, Marketing Authorisation Applications, variations) in collaboration with other disciplines and manage these regulatory procedures • Identify issues that will impact programs and provide strategies for dealing with them. • Provide advice to marketing group on labeling issues. • Act as regulatory representative on various cross-functional teams both regionally and globally and support Global Regulatory Affairs Leader for assigned projects. • Interface between Headquarters and European Affiliates to keep Affiliates updated on regulatory projects and issues arisen with their respective Health Authorities • Participates in Business Development efforts, if assigned. • Manage team of regulatory professionals and ensure development plans are in place for all staff, where assigned. Skills/Knowledge Required: Bachelors degree in scientific discipline; Advanced scientific degree preferred; Experience in Haematology/Oncology Drug Development required. Extensive experience in the pharmaceutical industry, (to include considerable period in regulatory affairs). Global experience highly desirable. Thorough knowledge of the drug development process, especially in oncology or haematology. Specific expert knowledge in one or more key areas- Drug Development/CMC/Pharmtox/Biopharmaceutics/Clinical/Promotion Inter-dependant partnering skills, team-orientated and demonstrated ability to influence outcomes are necessary skills in the environment. Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously. Must be able to innovate, analyze and solve problems with minimal supervision and attention to detail International travel will be necessary If you would be interested in exploring this particular job opportunity (F8213) with Ceglene, then contact Liftstream by either applying for the role via the online registration process or telephone us for a confidential and informative discussion. If contacting us during working hours is difficult, please feel free to email us on celgene@liftstream.com with your questions or to request an out of hours time to speak with our consultants.
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