- Managing all regulatory processes for our brand: Rx, OTC, food supplements, incl. management of product registration documents (procedures NP, MRP, DCP)
- coordination of all regulatory submissions and commitments, to obtain the approval decisions
- Close cooperation with medical team to ensure an optimal regulatory knowledge, requirement and procedures
- Substantive support for our brands strategies development and implementation
- Ensuring the regulatory affairs' activities are delivered on time, within budget with established procedures and regulatory requirements regarding distribution, marketing, logistics & medical department
- Monitoring current and changing local and European regulatory legislation
- Managing a team of Regulatory Affairs ( x2)
- Participating in bid defense meetings, project Kick-off meetings, audits, inspections, and other project related meetings according to the company / client needs
Substantial experience in the pharmaceutical Industry in a regulatory, medical or laboratory position
Knowledge of regulatory landscape and procedures within the country/region is highly desirable
Advanced PC skills including database applications such as Vault
Fluency in both Polish as the local language and English written and spoken
Display strong organizational and planning skills, along with meticulous attention to detail combined with the ability to work well independently and as part of a team, handling conflicting time pressures and a large volume of work.
Master's degree in pharmacy, Life Science or equivalent- Work in a hybrid model in a multinational pharmaceutical company
Opportunity and support to continuous development
Unlimited access to e-learning platform- Necessary work tools
- Benefit package
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Regulatory Affairs Manager - Warsaw, Polska - Michael Page
Opis
Użytkownicy zawodu Regulatory Affairs Manager w Warsaw
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Ewelina Naumnik
Regional Market Access Manager