- 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).
- 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.
- 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.
- 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.