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Senior Manager RA Oncology (m/f) - Germany
Daiichi Sankyo (company)
Posted on : 11 April 2017
- The Senior Manager RA Oncology will provide European or global regulatory guidance and strategy to assigned projects, products and assigned non-project work.
- He/She will lead or support European and global regulatory affairs development projects and product maintenance in a manner that is scientifically sound, commercially viable and in accordance with regulatory standards.
- The future incumbent will work as a specialist in the area of oncology, representing Regulatory Affairs in internal and external interactions (e.g. project teams, working teams, authorities, affiliates, partners).
European or Global RA representative in global development teams providing regulatory guidance and strategy for assigned projects:
- Develop regulatory strategies and advice and provide clear information based on experience and current knowledge of the Regulatory environment.
- Liaise, negotiate and communicate with functional groups within company, corporate partners, affiliates and agencies to obtain and/or provide information/data for regulatory submissions.
- Advise on submission and evaluate the content and adequacy of regulatory submissions; identify deficiencies requiring further resolution.
Plan, lead and manage regulatory submissions during development and life cycle management (including maintenance), e.g. CTAs and amendments, MAAs and variations, to European and other assigned authorities:
- Be directly responsible for on time delivery of regulatory submissions within EU RA responsibility.
- Prepare gap analysis of technical/clinical documentation vs regional and global requirements.
- Coordinate preparation of and prepare regulatory documents, when required, for submission, review RA and related documents for sign off prior to submission.
- Direct activities required for timely and accurate submission and tracking and reporting of submissions.
Act as regulatory contact person for authorities:
- Strategize, plan, liaise, negotiate and orchestra meetings and teleconferences with regulatory authorities.
- Initiate contact with regulatory authorities.
- Support or lead negotiations on Regulatory issues with regulatory authorities.
- Participate in or lead assigned non-project tasks designed to enhance the functionality and processes of RA
- Mentor/instruct and provide guidance to internal and external in-direct reports including consultants and CROs as well as plan, assign and direct work
- Manage competing priorities as appropriate
- Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives
- Attend meetings, seminars, conferences on relevant topics
- Design and revise SOPs and SOIs if required
- Communicate important changes and trends within EU RA and other functions when relevant.
Professional and personal skills:
- Bachelor degree in Life Science or Medical Science; Degree in Pharmacy, Master and/or PhD preferred
- Masters Degree in Regulatory Affairs is a plus
- Post-doctorate or professional experience in pre-clinical or clinical trials is a plus
- A minimum of 5-8 years experience in the pharmaceutical industry and 5 years direct regulatory affairs experience with emphasis on drug development and Marketing authorization applications in Europe (EU and non-EU)
- Experience with Clinical Trial applications, orphan drug applications and pediatric clinical development and/or interactions with PDCO is desired
- Working knowledge of laws, regulations and guidelines is essential
- Experience of working in a global, international regulatory environment and experience in the therapeutic area of oncology are required
- Understanding of drug development and regulatory processes
- Ability to interact effectively with National Agencies and EMA
- Ability to provide technical Input and proven ability to plan, coordinate and lead activities simultaneously on multiple projects
- Excellent interpersonal skills; ability to work across functions in a multinational organisation to accomplish results
- “Detailed-oriented", well organized and self-motivated with high ethical behavior
- Excellent written and oral communication skills in English; second language preferred
- Computer proficiency (e.g. MS Office)
What we offer:
We offer an interesting, diversified and challenging position, good contractual conditions, all the social benefits of a modern company and a professional environment where you will have the opportunity for personal growth.