Opis stanowiska podany przez pracodawcę:

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!

For our client specialized in pharma industry we are searching for a Regulatory Affairs Professionals in Submissions Publishing – mid and senior professionals.

Regular Specialist: The Experienced Regulatory Submissions Publishing professional is responsible for executing the electronic publishing of moderate to complex regulatory submissions for national, regional and global regulatory agencies and operating companies in both eCTD and non-eCTD format.

Senior Specialist: The Senior Regulatory Submissions Publishing professional is responsible for executing the electronic publishing of complex regulatory submissions for national, regional and global regulatory agencies and operating companies in both eCTD and non-eCTD format.    

Job Tasks:

• Navigating  through systems and tools to assemble, publish, validate, dispatch and archive complex submissions according to internal processes and regulatory guidelines for paper and electronic submissions with a high degree of independence
• Component-level publishing support for regulatory-owned deliverables in PDF format to ensure dossier components conform to submission standards (e.g., bookmarking, linking, PDF version, etc.)
• Applying appropriate regulatory submission standards, requirements, processes, and policies to ensure compliance with applicable internal and external health agency guidelines
• Maintaining open, timely, and effective communications with all publishing contributors and responsible regulatory affairs professionals
• Providing technical support and/or guidance to submission contributors on submission requirements, standards, and processes to facilitate efficient processing by regulatory agencies
• Managing multiple high complexity submissions simultaneously with a high-degree of independence
• Interpretation and enforcing paper and electronic regulatory submission standards, policies, and operating procedure requirements
• Close cooperation with various departments within RA matters

Requirements:

• Proficient use of Regulatory Information Systems, planning, and/or publishing tools
• Degree in pharmacy, bioscience or similar fields would be an asset
• Experience in in regulatory, medical, or pharmaceutical fields, or a background in information/library science
• Expert level knowledge of and experience with various submission and application types, publishing templates and relevant regulatory agency and industry guidelines
• Project or submission management skills
• Therapeutic area and product knowledge, in-depth understanding of product development process
• Fluency in English
• Ability to work or lead in a matrix environment  
• Effective interpersonal, teamwork, networking, and communication skills
• Skill in collaborating across an organization to influence and develop work practices, standards and procedures
• Skill to coach and/or mentor colleagues in applicable guidelines, standards and publishing requirements

Offer:

• Opportunity to join a global team and work on global innovative projects
• Option for 100% remote job within Poland
• Work mainly in English within an international team
• Attractive salary
• ManpowerGroup Benefit Package – healthcare, sports card, insurance, professional development program 

Permanent job offer.

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