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Director Regulatory Affairs Oncology (m/w/d) | Munich | Pharma

Director Regulatory Affairs Oncology (m/w/d) | Munich | Pharma

Job Title: Director Regulatory Affairs Oncology (m/w/d) | Munich | Pharma
Contract Type: Permanent
Location: München, Bayern
Industry:
Salary: basic + bonus + company car
Start Date: ASAP
Reference: RA_2020_21_1597066912
Contact Name: Sebastian Gotzler
Contact Email: s.gotzler@sciproglobal.de
Job Published: August 10, 2020 14:41

Job Description

Director Regulatory Affairs Oncology (m/w/d) | Munich | Pharma

Do you want to represent Regulatory Affairs internally working on a collaborative basis both within Europe and globally to become a fully recognised member of a multi-disciplinary team, providing expertise on regulatory matters? Are you interested in a challenging, global position in a company that combines history and innovation? Would you like to significantly improve health in the world? Are you an expert in oncology sector and are you ready for the next career step?

What will your tasks as Director Regulatory Affairs Oncology be?

  • European regulatory strategy leadership for assigned projects, covering product development plans, clinical trials and Marketing Authorizations Applications (MAA) as well as product life cycle management
  • European or Global RA representation on global development teams providing regulatory guidance and strategy and leading EU MAA submissions
  • Act as regulatory contact person for authorities
  • Participate or lead 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
  • Provide regulatory expertise in participating or coordinating assigned due diligence opportunities and making recommendations to senior management

What does the position offer you?

  • Type of contract: unlimited + full time
  • Vacation: 30 days / year
  • Working hours: 40 hours / week
  • Salary: Basic salary + Bonus + company car
  • 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?

  • Life Sciences degree (e.g. pharmacy, chemistry, biology or similar); Ph.D. would be a plus
  • 4+ years hands-on experience working in the oncology sector
  • 8+ years of experience in regulatory affairs in the pharmaceutical industry in a global environment
  • Experience of working with National Health Agencies and EMA
  • Proven ability to plan, coordinate and lead activities simultaneously on multiple projects
  • Very good communication skills when dealing with interdisciplinary multicultural teams; Management experience is an advantage
  • Very good knowledge English language - german and / or french are a plus

Information about our client:

The company is one of the 20 largest pharmaceutical companies in the world and operates in 12 European countries. With over 15,000 employees in 20 countries, the company develops and markets innovative medicines for patients in the field of hypertension, thromotic diseases and in the field of oncology. Are you addressing 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!

Get in touch at:
Sebastian Gotzler
+49 89 26 20 58 887 (direct dial)

I look forward to your application!