Regulatory Affairs and Pharmacovigilance Specialist

At Zentiva, we are a team of 4.800 unique talents bonded together by our common mission. We believe our diversity is a source of great energy and strength, and we create a work culture and ethics where everyone feels appreciated, can be their true selves, and contribute to the best of their ability. Seeking a balanced team across the company we welcome applications from all qualified candidates with various educational and industry experiences, cultural or ethical backgrounds, and different life experiences or abilities, regardless of their religious or philosophical beliefs or whomever they choose to love.

Regulatory Affairs and Pharmacovigilance Specialist

Currently, we are looking for a Regulatory Affairs and Pharmacovigilance Specialist to join our highly motivated and inspired team in Zentiva Croatia.

What Would Be Your Main Responsibilities:

carrying out activities required to obtain and maintain marketing authorization for medicinal products and medical devices

proposing and executing strategy and tactics needed to obtain and maintain marketing approval in a way which will satisfy the authorities and serve the best the company needs

understanding of local and EU regulatory requirements and business implications of new regulations

establishing and maintaining collaborative relationships with regulatory bodies

advising business and provide guidance/direction on regulatory matters, making recommendations and giving direction considering current and future trends

reviewing and approving the artwork

acting as a local person responsible for pharmacovigilance in front of regulatory body

maintaining the pharmacovigilance system

responsible for pharmacovigilance and product training of employees

ensuring compliance with regulations on medicine advertising and promotion

coordinating product recalls

carrying out activities required to obtain maximal price approval and positive reimbursement status

carrying out international and national reference pricing to maintain reimbursement

We Need You To Have:

University degree in life sciences: medicine, pharmacy, dental medicine, medical biochemistry

Excellent written and speaking English skills (You will need to communicate in person, on the phone and in writing with governing and regulatory body personnel and co-workers. You need to use specialized terminology.)

Computer skills at a highly proficient level

It is crucial for us to have satisfied employees. Therefore, we can offer you the following:

Competitive salary;

Additional benefit package;

International working environment and a passionate team of professionals;

Continuous Learning & Development opportunities thanks to our Zentiva Academy;

A hybrid form of work - on-site & off-site

Diversity is a fact. Inclusion is an act @Zentiva

At Zentiva, we are a team of almost 4,800 unique talents bonded together by our mission to deliver high-quality medicine to people whose lives depend on it. We strive daily to create a work culture where everyone feels appreciated, can be their true selves, and contribute to the best of their ability. Seeking a balanced team across the company, we welcome applications from all qualified candidates with various educational and industry experiences, cultural or ethnical backgrounds, and different life experiences or abilities, regardless of their religious or philosophical beliefs or whomever they choose to love. Join our winning team! Be a part of our winning culture! Be Zentiva.

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