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Senior Manager Regulatory Affairs Oncology (m/f/x)

  • Location: Münchendorf
  • Salary: negotiable per year
  • Job Type:Contract

Posted 12 days ago

  • Contact: Sebastian Gotzler
  • Contact Email: s.gotzler@sciproglobal.de
  • Expiry Date: 06 November 2021
  • Job Ref: RA_2021_27_1633591618

Senior Manager Regulatory Affairs Oncology (m/f/x) | Munich / remote | Pharma

In this role you will provide European regulatory strategy support for assigned projects, products and non-project work. You will act as a specialist in the area of oncology and represent Regulatory Affairs internally working on a collaborative basis, both within Europe (Spain & Portugal) and globally as a member of a multi-disciplinary team. You will represent Regulatory Affairs in external interactions (authorities, affiliates, partners, CROs) providing expertise on regulatory strategy to achieve regional and global goals.

What will your tasks as "Senior Manager Regulatory Affairs Oncology" be?

  • European regulatory strategy support for assigned projects, covering product development plans, clinical trials, and Marketing Authorizations Applications (MAA) as well as product life cycle management.

  • European Regulatory Affairs representation on global development teams providing regulatory guidance and strategy and supporting EU MAA submissions

  • Act as regulatory contact person for authorities for assigned projects

  • Participate in assigned non-project tasks and process improvements

  • Keep current with review and interpret regulatory and scientific regulations, directives, guidelines, and initiatives, communicate important changes and trends with the relevant stakeholders

What does the position "Senior Manager Regulatory Affairs Oncology" offer to you?

  • Type of contract: unlimited + full time

  • Vacation: 30 days / year

  • Working hours: 40 hours / week

  • Salary: Basic salary + Bonus

  • Benefits: Opportunities for further qualification, a pleasant working atmosphere in a committed team, flat hierarchies and short decision-making paths, various internal and external catering options, options for childcare in the surrounding area, wide range of health and sports activities (e.g. company doctor); highly flexible working model; attractive remuneration and benefits offer

  • Accessibility: On-site parking and very good public transport connections

  • Start date: As soon as possible

Your requirements as a "Senior Manager Regulatory Affairs Oncology"?

  • Bachelor's degree in Life Science or Medical Science; Degree in Pharmacy, Master and/or PhD preferred; Master's degree in Regulatory Affairs is a plus

  • Minimum of 8 years of experience in the pharmaceutical industry and minimum of 5 years of experience in global regulatory affairs with emphasis on late-stage drug development and marketing authorization applications in Europe, experience with clinical trials, orphan drugs and pediatric clinical development

  • Experience of working in global environment as well as with National Health Agencies and EMA

  • Proven ability to plan, coordinate and lead activities simultaneously on multiple project

  • Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organization

  • Ability to develop and maintain good relationships, challenge views, present and argue cases in a professional and respectful manner

  • Solution and detail-oriented; well organized and self-motivated

  • Excellent written and oral communication skills in English, second language preferred

Information about our client:

The company is one of the 20 largest pharmaceutical companies in the world and operates in 16 European countries. With over 15,000 employees in 20 countries, the company develops and markets innovative medicines for patients in the field of hypertension, thrombotic diseases and in the field of oncology.

Are you interested in this position? Then you should apply now! If you would like to receive further or alternative positions, I would also be happy to receive your application!

I look forward to your application!