Regulatory Affairs Business Partner (CHC, non-EU) w… - Jobeax
Opis oferty
Regulatory Affairs Business Partner (CHC, non-EU) w Gdańsk, Polska
POLPHARMA S.A.
HybrydowoPołączenie biura i pracy zdalnej
Poland, Gdańsk
Regulatory Affairs Business Partner (CHC, non-EU) w Gdańsk, Polska is listed on Jobeax. Browse 110,000+ vacancies available.
Dołącz do zespołu Regulatory Affairs Consumer Healthcare w Polpharmie i zostań kluczowym ekspertem odpowiedzialnym za rozwój portfolio CHC na rynkach non-EU.
Szukamy osoby z dobrą znajomością wymagań rejestracyjnych na rynkach Europy Wschodniej i Azji Centralnej, która samodzielnie prowadziła procesy rejestracyjne produktów leczniczych, potrafi podejmować decyzje regulacyjne i skutecznie wspierać rozwój biznesu na rynkach takich jak Ukraina, kraje EAEU czy Uzbekistan.
Na tym stanowisku będziesz:
opracowywać i realizować strategie rejestracyjne dla produktów leczniczych CHC na rynkach non-EU
samodzielnie prowadzić projekty rejestracyjne i porejestracyjne od etapu oceny możliwości rejestracji do uzyskania decyzji administracyjnej
współpracować z lokalnymi partnerami, agencjami regulacyjnymi oraz zespołami w krajach Europy Wschodniej i Azji Centralnej
... Senior Bank, Regulatory and Audit Management. - Proven relationship management skills with ability to deepen relationships and build partnerships across the business, executive leadership and key functional support areas like Government Affairs, Communications, Legal, Compliance, Control, in‑business Risk and Independent ...
... support Managing the implementation of enterprise platforms supporting Regulatory Affairs and Supply Chain operations Coordinating cross-functional teams, business stakeholders, and external vendors across multiple regions Identifying the scope of regulatory documents to be migrated, ensuring compliance with GxP and sector-specific ...
... support Managing the implementation of enterprise platforms supporting Regulatory Affairs and Supply Chain operations Coordinating cross-functional teams, business stakeholders, and external vendors across multiple regions Identifying the scope of regulatory documents to be migrated, ensuring compliance with GxP and sector-specific ...
... C1 level (certificate welcome). Main responsibilities - Elicit, analyze, and document business needs, user stories, and requirements specifications. - Model business processes, capabilities, roles, and data structures using BPMN and UML notations. - Support business experts and Product Owners throughout the complete software ...
... initiatives. If you are looking to work directly with corporate clients, traders, and global teams, while having a tangible impact on the value delivered to the business, this position is for you. Key Responsibilities: Manage and analyze client queries related to the regulatory reporting of their trades. Work closely with the ...
#OTCFteam to ludzie pełni pasji i zaangażowania. Przed nami wiele wyzwań i ciekawych projektów. Jakie zadania przygotowaliśmy dla HR Business Partner w Centrum logistycznym 4F? bliska współpraca z kadrą zarządzającą (głównie centrum logistycznego) w zakresie realizacji strategii biznesowej i HR, doradztwo i wsparcie w obszarze ...
Ciekawe projekty - Funkcja : Osoba do kontaktu dla naszych pracowników i kierowników w Polsce oraz do kontaktu z działem HR w Niemczech - Obsługa pracowników: kompleksowa obsługa i doradztwo dla naszych działów specjalistycznych we wszystkich kwestiach związanych z HR - Controlling: kontrola przestrzegania wytycznych
HR Solutions Group / HR Solutions of USA w międzynarodowej organizacji technicznej poszukuje doświadczonej osoby na stanowisko HR Manager / Senior HR Business Partner. Rola łączy strategiczny business partnering z odpowiedzialnością za kluczowe procesy HR, ze szczególnym naciskiem na Compensation & Benefits, prawo pracy, ...
Pharmavise Consulting Corp. is seeking a seasoned Consultant/Biologics to advise clients in biologics development, manufacturing, and regulatory affairs. This is a fully remote role with global exposure and frequent collaboration with life science teams. You will conduct gap analyses, develop regulatory strategies (CMC, ...
... Instagram — @capgeminipl or visit our Facebook profile — Capgemini Polska . You can also find us on YouTube . About Capgemini Capgemini is an AI-powered global business and technology transformation partner, delivering tangible business value. We imagine the future of organizations and make it real with AI, technology and people. ...
... kompletowanie dokumentacji administracyjnej, technicznej i finansowej. - Nadzór nad harmonogramem, terminami i jakością składanych ofert. - Współpraca z klientami, partnerami oraz działem prawnym. Wymagania: - Minimum 3 lata doświadczenia w Bid Management, Project Management, konsultingu lub sektorze publicznym. - Minimum 1 rok ...
... assigned projects - Responsible for all submissions and obtaining approval from IRB/ECs (incl CTIS Part 2 package); - May be responsible for submissions to Regulatory Authorities in non-EU countries (ex. UK, Georgia, South Africa etc) - Coordinate feasibility efforts and work together with Clinical Team Leads on site identification ...
... role works closely with stakeholders across the business to assess the effectiveness of regulatory controls and identify opportunities to strengthen TCCL's regulatory control environment. Key Responsibilities: Regulatory Controls Testing - Execute regulatory controls testing in accordance with the approved testing plan and ...
... delivering excellence in customer service Key Requirements - Master’s degree in (International) Tax, Law or in a related field - Capability to understand the EU regulatory framework and of international corporate (tax) structures - Ability to work both independently and as part of an (international) team - Excellent communication ...
... openCAPAs , CAPAs coming due Requirements - Minimum of a Bachelor degree in a Natural Science, Pharmacy, or other Healthcare-related field - ≥3years in pharmaceutical industryand regulatory experience - Solid understanding of at least one major Health Authority (FDA, EMA, MHRA….. ) regulations and Regulatory standards - ...
... or similar technologies is highly desirable. - Exposure to Artificial Intelligence (AI), machine learning techniques, and Large Language Models (LLMs) for business analytics is a plus. - Excellent verbal, written, and presentation skills with the ability to communicate complex regulatory concepts to senior stakeholders. ...
... Instagram — @capgeminipl or visit our Facebook profile — Capgemini Polska. You can also find us on YouTube. About Capgemini Capgemini is an AI-powered global business and technology transformation partner, delivering tangible business value. We imagine the future of organizations and make it real with AI, technology and people. ...
... on pay equity, regulatory compliance, and EU Pay Transparency directives. - Drive compliance monitoring and pay equity analysis, ensuring adherence to evolving EU pay transparency requirements across all applicable markets. - Partner with HR, Legal, and business leaders to enhance pay equity frameworks and continuously improve ...
... in partnership with regulatory leaders, ensuring compliance, and coordinating activities to support global submissions. The ideal candidate has a Master's in Life Sciences and significant experience in regulatory labeling. The position offers opportunities for professional growth in a diverse and innovative environment.