Regulatory Affairs Associate

Krka is one of the leading generic pharmaceutical companies in the world. We have now been successfully implementing our strategies and pursuing our mission and vision for more than 60 years. Krka’s basic line of business is the production and sale of prescription pharmaceuticals, animal health pharmaceuticals and non-prescription products. Krka´s medicines are trusted and known for their high quality. Krka´s products are produced in Europe and sold in over 70 countries. We would like to invite you to join our team in KRKA France as a: Regulatory Affairs Coordinator (Junior) Location: Paris France Department: Regulatory Affairs Experience Level: Entry-level / Junior Job Summary: We are looking for a motivated Regulatory Affairs Coordinator to support the preparation and submission of regulatory dossiers for pharmaceutical products in France. This is an ideal opportunity for a recent graduate or junior professional seeking to build a career in regulatory affairs within a dynamic and regulated environment. Key Responsibilities: Assist in preparing, submitting, and tracking regulatory dossiers (AMM, variations, renewals) for submission to competent authorities Coordinate the collection and formatting of CTD/eCTD documents Liaise with internal teams (Quality, Pharmacovigilance, Manufacturing, etc.) to gather necessary documentation Ensure the compliance of labelling, SmPC, and PIL according to national and EU requirements Maintain regulatory databases and documentation systems ( archives, tracking tools). Monitor regulatory changes in France and summarize updates for internal distribution Support the preparation of responses to questions from health authorities Profile / Requirements: Degree in Pharmacy, Life Sciences, Biochemistry, or related field 0–2 years’ experience in regulatory affairs (internship or apprenticeship welcome) Familiarity with French and EU regulatory environments (ANSM, EMA procedures, variations, renewals, etc.) Knowledge of ICH and EU regulations , and understanding of eCTD format is a plus Strong communication skills in both French and English (written and spoken) Organized, detail-oriented, and able to manage multiple tasks under deadlines Proficient with Microsoft Office; knowledge of RIMS or document management systems is a plus Proficiency in French and English language Compensation: Competitive salary and benefits Work an international company Possibility of professional and personal growth

Location: Paris, FR

Posted Date: 7/5/2025