Associate Director Oncology (m/f/d)

REFERENCE NUMBER:

467189/1

MY DUTIES:

- Provide regional strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements 
- Effectively communicate objective assessments of the likelihood of success of these regulatory strategies
- Provide regulatory expertise and strategic focus for assigned development projects and /or marketed product life cycle management
- As Regional Lead, you may be called upon to act as deputy to the Global Regulatory lead, attending internal leadership team meetings, as appropriate
- Monitor and inform on emerging trends, regulations and changes, with emphasis on those related to project areas and/ or region of responsibility enabling proactive approach and planning to future business requirements
- For Europe based roles, primary EMA contact for project(s)/products of responsibility 
- Manage interactions with EMA and national health authorities (and HTAs in context of parallel consultation) in the Europe Union and European Economic Area for specific product(s)

MY QUALIFICATIONS:

- Pharmaceutical industry experience
- BS degree or equivalent in science; advanced degree preferred
- Considerable experience within the pharmaceutical industry and including direct experience in regulatory affairs in development and /or post-marketing phases
- Sound working knowledge of regulations and guidances governing drugs and biologics in development, including post-marketing in the US and/or EU (relevant to role)
- A good understanding of basic regulatory requirements in emerging markets is of advantage 
- Awareness of evidence requirements beyond the regulators (e.g. HTA bodies)
- Understand and interpret complex scientific issues and capability to relate to regulatory requirements and strategy
- Proven regulatory submissions capability in a region (Europe, US, EM)
- Generally strong in most and acceptable in all basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability
- Able to demonstrate skill(s) in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally

MY BENEFITS:

- Willingness to travel to various meetings, including overnight trips, approximately up to 10-30% travel.

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

MY CONTACT AT HAYS:

My contact person
Yvonne Hollatz

Reference number
467189/1

Contact
E-Mail: [email protected]