Regulatory Affairs Specialist

Join Polpharma as a Regulatory Affairs Specialist and play a key role in ensuring regulatory compliance and lifecycle management of pharmaceutical products across international markets. In this position, you will contribute to the preparation, submission, and maintenance of regulatory dossiers, collaborating in a dynamic, multinational environment and supporting the successful registration of products worldwide.

Your responsibilities:

• Prepare, review, and submit regulatory dossiers (eCTD) for Marketing Authorisations, variations, and renewals in the EU and worldwide

• Assist in developing and implementing regulatory strategies for new and existing products

• Coordinate and prepare responses to queries from regulatory authorities

• Collaborate with cross-functional teams and external partners

• Support lifecycle management activities and maintain regulatory data

• Work in a multinational and multilingual environment, collaborating with global teams, partners, and B2B clients across different geographies and cultures

Our requirements:

• University degree in Pharmacy, Chemistry, Biochemistry, Medicine, Biotechnology, or a related field

• Minimum 3 years of experience in Regulatory Affairs or drug registration

• Familiarity with EU guidelines for registration processes and post-registration changes

• Knowledge of regulatory requirements in countries outside the EU is an advantage

• Advanced level of English (both written and spoken), enabling fluent communication and documentation work

• Computer literacy, including MS Office skills

• Strong communication and collaboration skills

• Good organizational skills and openness to change

• High level of responsibility, precision, and attention to detail

• Ability to work effectively in a team environment

We offer:

• Permanent contract

• Private healthcare and life insurance

• Training and development opportunities

• Multisport card and additional benefits

• International working environment

• Christmas packages for children

• One extra day off

• Retirement plan