Mylan is one of the world’s leading generics and specialty pharmaceutical companies, providing products to customers in approximately 145 countries and territories. The company maintains one of the industry’s broadest and highest quality product portfolios, which is regularly bolstered by an innovative and robust product pipeline. With a workforce of more than 30,000, Mylan has attained leading positions in key international markets through its wide array of dosage forms and delivery systems, significant manufacturing capacity, global commercial scale and a committed focus on quality and customer service. At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the world’s 7 billion people. If you are unconventional, relentless and passionate. If you believe in doing what’s right, not what’s easy. If you are a ‘doer’ and have a passion for serving others, we want to talk to you.

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Location: Zagreb, Croatia

Contract type: Fixed term

Make a Difference

At Mylan, each person has the ability to make a difference. From the providers who sell and market our products to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Here’s how this role will help:

Core Job Responsibilities:

Registration of new products and maintaining current registration according to global and local procedures of Mylan and local laws and regulations
Solving regulatory issues on product registrations of the company’s portfolio
Maintain central control of documentation to ensure availability of information for the submission and maintenance of government licenses
Ensure that the technical content of the packaging leaflets and product labels meets the regulatory requirements and Mylan policies
Play an active role in New Product Introduction Team in terms of planning, coordinating and monitoring that everything is according to the launch plan
Collect information from the market as market condition changes, registration regulations / guidelines, etc.
Determine appropriate regulatory reporting requirement(s) in accordance with the local and global regulations and guidelines

Qualifications:

University degree (Pharmacy, Biotechnology, Medicine or similar formal education)
Experience in the same/similar regulatory positions is preferred
Excellent knowledge of English language
Solid PC skills
Ability to perform in streched situations

Why Mylan?

Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that, by working together we can run faster, reach higher and achieve more. If you want to be part of a global health care company that is making a difference and changing lives, Mylan may be the place for you. We encourage you to visit Mylan.com to learn more about our unconventional approach and how your skills might complement our mission.

Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. Mylan is an Equal Opportunity Employer. All information received will be handled carefully and treated with confidentiality.

If you want to be part of our team please apply for the position before {END_DATE}
Only selected candidates will be contacted. We thank the other candidates for applying.

Regulatory Affairs Specialist (m/f)

Mylan

Viatris Hrvatska d.o.o.

Prosječna neto plaća u kategoriji Farmaceutika i biotehnologija iznosi 1292.58 EUR*