Regulatory Affairs Established Products Manager

Job title:

Regulatory Affairs Established Products Manager

Company:

Randstad

Job description

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.Regulatory Affairs Established Products Manager Nr ref.: 566/1/2025/PR/259491/jobs.pl Warszawa (mazowieckie)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.

What we expect

• education: Minimum of a Bachelor’s 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 47this job offer is intended for people over 18 years of age

Expected salary

Location

Warszawa, mazowieckie

Job date

Sun, 02 Feb 2025 23:58:54 GMT

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