Bayer is a global enterprise with core competencies in the fields of health care and agriculture. As an innovation company, it sets trends in research-intensive areas. Bayer’s products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Head of Regulatory Affairs Serbia m/f

(Belgrade)

YOUR TASKS AND RESPONSIBILITIES:

• Responsible from below indicated all regulatory activities Pharma, Radiology & Intervention and Consumer Care in Serbia, Kosovo and Montenegro
• Responsible for the all regulatory affairs activities (new submissions, CMC, labelling variations, PSUR submission, renewals etc.) for the whole portfolio including administration of all kinds of processes dealing with the Ministry of Health in relation to pharmaceuticals (Rx-Non-Rx), medical devices, cosmetics, food supplements marketing authorization / permission / notification
• Responsible for local Regulatory compliance in accordance to local regulations and internal procedures 
• Responsible for planning the registration application timelines and shares the anticipated approval timeline with related parties (i.e. Business Units, Supply Chain, Global Regulatory Affairs, etc.) and informs any changes on committed timelines associated with an risk analysis and plan of actions required with concerned parties in the company 
• Develops proactive and reactive strategies to ensure improvement of registration approval process 
• Managerial responsibility of the regulatory affairs staff in the country, incl. talent management and people development
• Responsible for the preparation of local budgets and the adequate hiring and training of staff 
• Identifies resource requirements and allocates resources to meet regulatory needs 
• Ensures early identification of conflicts between projects and ensures transparent and aligned prioritization
• Provides local RA intelligence: Identifies current and emerging national regulations which impact registration processes. Proactively shapes the regulatory environment in the country
• Responsible to represent Bayer Serbia as a competent reliable partner to the local Health Authorities in all regulatory matters, to enable timely approvals with optimal labels. Builds and develops the relations with Ministerial bodies at Ministry of Health or other relevant. Ensures appropriate representation of Bayer Serbia in the local industry associations. Oversees communication with Health Authority to ensure Bayer one voice policy 
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WHO YOU ARE

• University degree in Medicine or Pharmacy
• At least 5 years work experience in the Pharmaceutical Industry in Regulatory Affairs
• At least 3 years experience in a managerial functions
• Familiar with current local guidelines and regulations
• Outstanding leadership and inter-personal skills
• Excellent negotiation skills and high credibility
• Good administrative and organisational skills
• Strong focus on achievement of goals and continuous improvement
• Fluency in English and Serbian
• Use of information technologies and IT Systems
• Valid driving licence

KEY COMPETENCIES

• Strategic mind-set, Customer focus, Drives results, Builds effective teams

If you meet the requirements of this unique opportunity, please send your application letter and CV electronically until 04.12.2015.

Only short-listed candidates will be contacted.

Passion to innovate | Power to change