International Regulatory Affairs Liaison (m/f/x) | 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 International Regulatory Affairs Liaison be?
- Support Local/regional regulatory teams for assigned products for assessing regulatory landscape and regulations to optimise our regulatory strategies and submission plans and provide regulatory input into Development Strategy to enable timely commercial desirable registrations across the regions.
- Advise global teams on specific local requirements or gaps in the global clinical development to support local submissions and collaborate to develop mitigation plans (e.g. bridging/sub-population requirements).
- Champion for countries to obtain the needed global and regional resources (e.g. to participate in global registration-directed trials, to prepare bridging reports, to respond to health authority queries rapidly).
- For assigned products work with Global and Local Regulatory Teams and communicate project specific information to local teams, ensuring alignment between registration/submission requirements and local development plans, support translation of global regulatory expectations into local plans and support the execution of these plans.
- Keep current with, review and interpret international regulatory and scientific regulations and initiatives, communicate important changes and trends with the relevant stakeholders, 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
- 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
- Bachelor degree in Life Science or Medical Science; Degree in Pharmacy, Master and/or PhD preferred; Master Degree in Regulatory Affairs is a plus
- Minimum of 5 years of experience in global regulatory affairs with emphasis on International drug development and marketing authorisation applications in International Markets.
- Experience of working in global environment.
- Proven ability to plan, coordinate and lead submission activities simultaneously
- Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organisation.
- Ability to develop and maintain good relationships, gain the trust of others, challenge views and present and argue cases in a professional and respectful manner.
- Solution and detail-oriented; well-organised and self-motivated.
- Excellent written and oral communication skills in English, Spanish and/or French as a 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, thromotic 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!