Regulatory Affairs Established Products Manager

3 tygodni temu


Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etat
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 47

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

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