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Regulatory Affairs Project Lead (2 years contract)

Req # JR - 035347 Location Warsaw, Mazovia Job Category Regulatory Affairs Date posted 02/23/2021

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Summary

Responsible for Regulatory documents planning and submission process for assigned projects/products in markets for acquired product/s to ensure complete transfer of products ownership to Baxter in countries in-scope including MAH transfer, labelling, promotional material updates  and complete regulatory obligations related to production transfer.

Essential duties and responsibilities

Submissions Planning:

  • Responsible for tracking, generating and maintaining the project status & information in major submissions as requested,

  • Regulatory Liasion between countries RA teams in ECEMEA (SEE, CE, ME, Afirca and Russia & CIS) and global regulatory project team and other parties including (but not limitted to) external suppliers, Seller regualtory point of contact (where required) ,  Manufacturers and authorities...etc. to ensure project execution on time,

  • Map most latest and valid country submission document requiremnents for countries in scope,

  • Keep track of emerging regulatory trends in ECEMEA markets with potential impact on Project time,

  • Perform regulatory gap analysis between country regualtory docuemnt requirements versus available docuements, indentify and falg 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 project teams 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 Project plan,

  • Manage the assembly, review and technical approval for regulatory dossiers and documents for assigned products.

Project management:

  • Manage end to end project scheduled tasks and RA delieverable 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 mitagation plan (where needed),

  • Manage and report submission updates within defined timelines against milestones and define risks which could affect submission timeline,

  • Management of submission content/format to ensure high quality submissions to Regulatory Authorities,

  • Represent ECEMEA markets, on assigned project, with cross-functional project teams,

  • Establish appropriate communication within RA and with other functions to ensure Regulatory activities meeting timeline of the project.

Additional Responsibilities:

  • Establish and maintain positive relationships with cross-functional counterparts,

  • Ensure the use of appropriate document policies and standards to create “Regulatory Submission Ready” documents and maintain confedentiality (where needed),

  • Special high value project leadership and support as assigned.

Qualifications

  • Minimum of 4 years regulatory experience in international environment, including demonstrated experience in project management (i.e. product acquisition) and regulatory submissions (drug),

  • Clear understanding of EU file requirements regarding submission content and format is required,

  • Clear understanding of NeeS/CTD/eCTD requirements,

  • Technical understanding and project management skills,

  • Sound knowledge of regulatory environment and requirements in EU Emerging markets of EMEA (Middle East, Africa, Russia & CIS),

  • 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.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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