HEAD OF GLOBAL REGULATORY AFFAIRS

Type of job: full-time

For prestigious biotechnological company I am looking for Head of Global Regulatory Affairs. The Head of Global Regulatory Affairs will be responsible for forming the regulatory strategy of the client and leading all aspects of client's regulatory authority interactions on a global level. Head of Global Regulatory Affairs will have leadership and management experience with Phase 3 and commercial Biotechnology companies, including significant experience related to oncology. You will provide strategic input into clinical development plans, commercial product launches, and the company business plan. 

Main responsibilities: 

• Build the appropriate staff, structure, and organization that will successfully provide Regulatory oversight for all development programs globally. 
• Establish and lead positive and collaborative relationships with all national and country regulatory authorities. 
• Provide global strategic guidance on development programs and commercial launches. 
• Create and foster a simple and effective systems and environment of compliance to all GXPs and applicable laws and regulations for client's global business as relates to Regulatory Affairs. 
• Provide advice on all regulatory matters related to all products and process to the company executives and their respective departments. 
• Lead the submission process for all regulatory applications (e.g. MAA, BLA, IND, VHP). 
• Set up the appropriate internal processes to create and maintain all regulatory documentation. 

Requirements: 

• At minimum Bachelor's degree in a science and/or medically related subject, advanced degree preferred (e.g. PhD, etc.). 
• A minimum 10 years of biotechnology or pharmaceutical leadership and management experience is required. 
• Proven results in Regulatory leadership for previous companies working in product development and the commercial market for biopharmaceutical, or pharmaceutical company. 
• The ability to work on global executive committees and collaborate with other country specific and global executives and their staff. 
•  Working knowledge and experience with electronic documentation systems and other related systems. 
• Experience and expert knowledge of EMA processes and related GXP processes and directives. 
• Knowledge of the CFRs, specifically as they relate to GMPs, GCPs, and GLPs. Knowledge of the GTPs preferred. 
• Experience with managing electronic submissions and proactive communications with the CBER office of FDA. 
•  Ability to analyze regulatory strategy and its effect on the business strategy. 
• Demonstrated excellent leadership, communication and presentation skills. 
• Strategic and result-driven decision-maker, thinking "out-of-the box", highly effective in communication and relationship-development across various organizational levels and across various business and academic companies and associations. 
• Executive leadership and influencing skills, strategic planning and organization, decision making and problem solving skills. 

The position will be based in Prague, Czech Republic. 

Language skills: English - proficient level. 

Offer: 

• Interesting job, nice working environment and colleagues 
• Motivating salary 
• Employees´ benefits (e.g. 5 weeks holiday, bonus, pension contribution etc.) 

Start date: upon agreement. 

In sending your CV you give your consent to processing and holding of your personal data in accordance to Act. No. 101/2000 Coll. regarding personal data protection by LN Human Resources s.r.o., ID: 24275336 until a written form revocation. Your personal data can be provided to third persons in order to obtain employment, namely after prior approval. 

Contact:
Ing. Lada Neškrábalová

E-mail:
lada.neskrabalova@LNHR.eu

Telephone:
722 950 102

Updated: 12.2.2015