Along with ManpowerGroup Solutions, we are seeking a candidate for the position of Senior Regulatory Affairs Professional-Analyst (M/K).
The Company we are recruiting for is a global leader in pharmeceutical innovations, specializing in innovative reasearch and clinical trials. As a global company they are representing international values and creating multicultural working environment. Seize this opportunity for work in a very well-known organization and join our client as a Senior Regulatory Affairs Professional/ Analyst!
Tasks:
Apply now to contribute to impactful projects and enjoy comprehensive benefits designed to enhance your professional and personal well-being. Join the team of our client and elevate your career in regulatory affairs today!
Employer: ManpowerGroup Solutions Sp. z o.o.
The Company we are recruiting for is a global leader in pharmeceutical innovations, specializing in innovative reasearch and clinical trials. As a global company they are representing international values and creating multicultural working environment. Seize this opportunity for work in a very well-known organization and join our client as a Senior Regulatory Affairs Professional/ Analyst!
Tasks:
- Participating in Working groups to ensure timely regional and local input into product objectives, to align regions with CDT/global strategy
- Working with the regional staff and LOCs to support regional and local activities
- Assisting in the preparation of meetings with Regulatory Agencies
- Assisting in the development of processes related to regulatory submissions
- Drafting and reviews document content (depending on level of regulatory knowledge/expertise
- Providing regulatory support throughout registration process and life-cycle management (e.g. iCTDs, ACTDs, renewal applications, Health Authority
- Responding site registrations and routine marketed product submissions including PSURs, RMPs)
- Advising team on required documents in preparation of submissions as assigned
- Responsibility for the critical review of submission documents to ensure compliance with regulatory requirements
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field
- Proven experience in regulatory affairs, specifically in global submissions within the healthcare industry
- Strong understanding of international regulatory requirements related especially to submission requirements for lifecycle submissions e.g., protocol amendments,post-approval variations, annual reports, PSURs, DSURs, RMPs, renewal applications
- Excellent organizational and project management skills with attention to detail
- Awareness of competitive landscape, e.g., views of HA, regulatory precedence, labeling differences and product related issues
- Effective communication skills in English, both written and verbal
- Ability to work independently and collaboratively within a multidisciplinary team
- Proficiency in regulatory software and document management systems
- Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) is advantageous
- Employment via ManpowerGroup Solutions based on an employment contract for 12 months
- Flexible work arrangement: remote (outside Warsaw) or hybrid (Warsaw-based)
- ManpowerGroup employment benefits including healthcare coverage
- Additional perks such as a Sport Card to support a healthy lifestyle
- Opportunities for professional development and career growth within a global organization
- Supportive and inclusive work environment in Warsaw, Poland
Apply now to contribute to impactful projects and enjoy comprehensive benefits designed to enhance your professional and personal well-being. Join the team of our client and elevate your career in regulatory affairs today!
Employer: ManpowerGroup Solutions Sp. z o.o.
Manpower (Agencja zatrudnienia nr 412) to globalna firma o ponad 70-letnim doświadczeniu, działająca w 82 krajach. Na polskim rynku jesteśmy od 2001 roku i obecnie posiadamy prawie 35 oddziałów w całym kraju. Naszym celem jest otwieranie przed kandydatami nowych możliwości, pomoc w znalezieniu pracy odpowiadającej ich kwalifikacjom i doświadczeniu. Skontaktuj się z nami - to nic nie kosztuje, możesz za to zyskać profesjonalne doradztwo i wymarzoną pracę!