Informacje o stanowisku

as Manager, Regulatory Affairs Established Products, you will be responsible for the regulatory support of a portfolio of established oncology and internal medicine products. Your objective will be to ensure compliance with regulatory requirements and to implement the global regulatory strategy for post-approval products.

What we expect

• education: Minimum of a Bachelors degree in Life Sciences, Pharmacy or related field (MS, PhD, MD or PharmD preferred).
• experience: several years of regulatory affairs experience in the pharmaceutical industry preferred.
• familiarity with regulatory processes, including registration procedures and lifecycle documentation management.vVery good
• knowledge of FDA regulations and global drug guidelines.
• strong communication skills and ability to work in a cross-functional environment.
• ability to manage and prioritise multiple projects simultaneously.

Employment agency entry number 47

this job offer is intended for people over 18 years of age

What we offer

• opportunity to work in an international environment and gain experience in global post-approval product management.
• influence regulatory strategy for established products on the market.
• work with experts in a variety of fields - from clinical trials to drug safety management.
• career development in a stable and key area of Regulatory Affairs.

Your tasks

• management of regulatory activities for medicines already on the market, including implementation of the post-approval development strategy.
• ensure compliance with global and local regulatory requirements and their continuous updating.
• preparation and submission of INDs, NDAs, CTAs and CTD documentation for registration and post-registration variations.
• product lifecycle management including submission of IND/NDA, PSUR, PADER annual reports and label updates.
• maintaining liaison with the FDA and other regulatory agencies, including correspondence and management of safety submissions.
• provide advice to cross-functional teams on regulatory requirements and registration strategies.
• participate in Established Products regulatory audits and inspections.
• support strategic portfolio optimisation initiatives.

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