Regulatory Submission Manager

Job Ref: J30933
Sector: Clinical
Sub-sector: Pharmaceuticals
Job Type: Permanent
Date Added: 20 March 2019
  • Warsaw, Poland Warsaw Poland 00000
  • Competitive
  • Emanuele Giansanti

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Regulatory Submissions ManagerFully Office Based - Extremely Competitive PackageMultiple Locations Available: Warsaw, Prague, Budapest.

Having previously our client, a growing Global Clinical Research Organisation, with individuals for Clinical Project Management and Monitoring; we are now helping them to build a global team of Regulatory Affairs Specialists based across Europe.

Specifically, we are looking for proficient a Regulatory Submissions Managers. This position plays a key role in the clinical trial management process and will be responsible for all the main tasks associated to Regulatory Submissions and Notifications, while providing Project Management and Regulatory oversight.

Additional repsonsibilities include, but not limited to:

  • In charge of the execution of all Regulatory aspects of global start-up;
  • Take on quality checks on submission documents and site essential documents (CTAs, ECs)
  • Preparation, review and approval of informed consent forms;
  • Able to take part in and carry out bid defenses, general capabilities meetings, and audits.

Qualifications:Life Sciences degree qualified (Essential)

  • Extensive industry experience clinical Regulatory Affairs ideally with a CRO. Experience may include CRA or project management experience;
  • Strong hands on exposure within Clinical Regulatory submissions.
  • Strong oral and written communication skills both in English and Local Language, depending on location.

WANT TO APPLY?For an immediate consideration please press 'apply' or alternatively contact Emanuele either via email () or on the phone (+44 0203 910 9516) now and get more information about the role.Our team at SRG Clinical also cover roles in Biometrics, Medical Affairs, Clinical Operations, Medical Information, Pharmacovigilance and Regulatory affairs so do not hesitate to get in touch.Fancy getting rewarded? We find that good people know good people. So when you recommend a friend to SRG and we place them in a contract or permanent job, you could earn a bonus of up to £1,000 of Red Letter Days vouchers as a thank you. words: CRO, Pharma, Pharmaceutical, Biotechnology, Biotech, Clinical Research Organisation, Medical Device, Permanent, Freelance, Contract, Full-time, Temporary, Regulatory Affairs, Regulatory Submissions, Submissions Manager, Country Clinical Operations, CCO, TAL, Line Management, Leadership, People Skills, Oncology, Respiratory, Cardiovascular, cardiology, Rheumatology, Diabetes, Ophthalmology, Dermatology, Urology, CNS, Neurology, haematology, orphan diseases, nephrology, musculoskeletal, endocrinology, gastroenterology, infectious diseases, Budget, Protocol, Vendor oversight, Vendor management, Vendor meeting, Line Management, Ethics submissions, Regulatory body

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

19/04/2019 16:16:04
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