Regulatory Affairs SIP Manager

Regulatory Affairs SIP Manager

Baxter International

Warsaw, Poland

Summary

The Regulatory Affairs Manager SIP (Specialty hospital products) in a newly formed business unit is responsible for the regional regulatory activities of SIP portfolio across ECEMEA region.

You will play liaison role across ECEMEA RA teams to ensure on-time execution of regulatory activities of projects in-scope includes but not limited to new acquisitions, New products introduction, products Variations impacting SIP portfolio across ECEMEA region.

You will be working closely with WE SIP RA team to ensure alignment, collaboration and execution of RA plan on time.

Major Duties and Responsibilities:

Role Key responsibilities:

  • Responsible for tracking, generating and maintaining the projects status & information in major submissions as requested;
  • Regulatory Liaison between countries RA teams in ECEMEA (SEE, CE, ME, Africa and Russia & CIS) and global regulatory and other parties including but not limited to external suppliers, Manufacturers and authorities...etc. to ensure project execution on time;
  • Keep track of emerging regulatory trends in ECEMEA markets with potential impact on portfolio in-scope;
  • Regulatory representative for SIP portfolio/projects in-scope cross functions and business;
  • Perform regulatory gap analysis between country regulatory document requirements versus available documents, identify and flag in case of risk on timelines to stakeholders and propose solutions where needed;
  • Works with ECEMEA countries RA team, and Global RA to review and submit Responses to regulatory authorities’ questions and LODs within strict deadlines;
  • Understand the technology used to support all aspects of the submission and publishing process;
  • Work with global RA, R&D and country RA to coordinate all system training needed for the submissions;
  • Develop and execute role-based regulatory plans with countries RA aligned with agreed Projects plan;
  • Map latest and valid country submission document requirements and building registration data base for ECEMEA countries.

Project management activity scope:

  • Manage end to end projects scheduled tasks and RA deliverable including submission in planning, coordinating and executing regulatory submission development, based upon thorough knowledge of applicable regulations;
  • Identify if there are any risk on RA Milestones due to interdepency to other functional tasks, flag and engage cross functional workstreams to prepare mitigation plan (where needed);
  • Work closely with RA SIP team of WE to ensure alignment and on-time execution of regulatory activities for projects in-scope;
  • Manage and report submission updates within defined timelines against milestones and define risks which could affect submission timeline;
  • Establish appropriate communication within RA and with other functions to ensure Regulatory activities meeting timeline of projects.

Qualifications

  • Minimum of 5 years regulatory experience, including demonstrated experience in project management and regulatory submissions (drug);
  • Clear understanding of EU pharma regulations, requirements regarding submission content and format is required education;
  • Sound knowledge of regulatory environment and requirements in key Emerging markets of EMEA (e.g Russia, Gulf countries, Turkey, S.Afric,) is plus;
  • Clear understanding of NeeS/CTD/eCTD requirements;
  • Technical understanding and project management skills;
  • Demonstrated interpersonal skills including strong negotiation skills;
  • Ability to multitask and manage multiple and changing priorities;
  • Strong interpersonal, communication and presentation skills;
  • Ability to manage complex projects and timelines in a matrix team environment;
  • Highly self-motivated individual and self-starter, independent worker;
  • Ability to work under pressure and adhere to deadlines;
  • Ability to work effectively in multinational/multicultural environment;
  • Computer proficiency in Microsoft Office required, including: Word, Excel, PowerPoint, Project, Outlook and Visio;
  • Experience in electronic document management/publishing systems is desired;
  • Fluent command of spoken and written English.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

More Job Searches

Poland     Clinical Research     Manager and Executive     Regulatory Affairs     Baxter International    

© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies