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Regulatory Affairs EMEA Regional Manager- Pharmaceuticals

Req # JR - 072149 Location Dublin, Leinster, Ireland Job Category Regulatory Affairs Date posted 06/24/2022

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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.

Regulatory Affairs EMEA Regional Manager- Pharmaceuticals

The regulatory Affairs Regional manager is responsible for supporting the regulatory activities related to all pharmaceutical products across the EMEA region, including SIP (specialty injectable products), inhaled anesthesia and compounding (where applicable).

He/she will play liaison role with the regional commercial teams and the global Pharmaceutical business unit to ensure on-time execution of regulatory

activities of all projects in-scope. This includes but not limited to new

acquisitions, New products introduction, and maintenance of the existing pharma portfolio across the WE  region.

Major Duties and Responsibilities:

Submissions Planning:

  • Responsible for tracking, generating and maintaining the project status & information in major submissions as requested
  • Regulatory Liaison between countries RA teams in EMEA including, but not limited to external suppliers, Seller regulatory point of contact (where required) , Manufacturers and authorities...etc. to ensure project execution on time.
  • Map most latest and valid country submission document requirements for countries in scope.
  • Keep track of emerging regulatory trends in WE with potential impact on Project time.
  • For new product submissions, develop regional specific regulatory plans in liaison with local RA for incorporation into the global regulatory strategy document.
  • For geo expansion molecules, perform regulatory gap analysis with local RA on country requirements versus available core dossier documents; identify and flag in case of risk  on timelines to stakeholders  and propose solutions where needed.
  • Work with the global regulatory team to support the modification of the EU core dossier (all modules) as needed to close identified gaps in regulatory document requirements
  • Works with EMEA countries local 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

Project management:

  • Serve as primary regulatory contact for the regional marketing/commercial teams in WE to support all aspects of the pharma portfolio
  • Participate as a member of the regional regulatory leadership team
  • Ensure close alignment with regional regulatory lead to provide project updates and secure resources to support all pharma specific projects
  • Manage end to end project scheduled tasks and RA deliverable including 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 interdependency to other functional tasks, flag and engage cross functional workstreams to prepare mitigation 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 WE 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:

  • Play liaison/leader role between WE local RA teams and global/central RA team in  Change control RA activities and CCDS update to ensure meeting Baxter timeline and to ensure submission/approval are tracked regularly. 
  • Special high value project leadership and support as assigned.
  • Process improvement that allows smooth implementation of RA activities for projects in-scope.
  • Responsible for all Advertising/Promotional activities for the Pharma business unit in the EMEA region

Qualifications

  • Minimum of 5 years regulatory experience, including demonstrated experience in project management and regulatory submissions (drug)
  • Sound knowledge of regulatory environment and requirements in EMEA markets
  • 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

What are some of our benefits of working at Baxter?

  • Competitive total compensation package
  • Professional development opportunities
  • High importance placed on work life balance
  • Commitment to growing and developing an inclusive and diverse workforce.
  • Baxter is committed to growing and developing an inclusive and diverse workforce – you can read more about our specific values here https://www.baxter.com/careers/inclusion-diversity.

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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 [email protected] and let us know the nature of your request along with your contact information.

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