Pfizer Manager in Little Island, Ireland

The Closing date for applications is Tuesday 26th February 2019.

The Manager, Regulatory Affairs CMC, Upjohn, possesses CMC regulatory knowledge and quality expertise to independently prepare regulatory assessments & contribute to global regulatory strategies for projects across all aspects of drug development or manufacturing lifecycle and works to support the Upjohn product portfolio.

The Manager, Regulatory Affairs CMC, Upjohn is accountable for:

  • Ensuring regulatory conformance & consistency globally and in compliance with external regulatory requirements & internal quality procedures.

  • Demonstrating regulatory knowledge & experience, balanced judgment, crisp decision-making, exemplary collaboration & business acumen , i.e., regulatory strategy development, regulatory submission quality, investigations, review of policy & quality standards

  • Development and provision of robust regulatory strategies, leveraging both technical & regulatory knowledge, to mitigate risks.

  • Preparation & Delivery of high quality CMC regulatory submissions & submission management plans for global regulatory agencies.

  • Execution of regulatory policies and implementation of policies and operational processes for delivering the product portfolio.The Manager, Regulatory Affairs CMC, Upjohn, possesses CMC regulatory knowledge and quality expertise to independently prepare regulatory assessments & contribute to global regulatory strategies for projects across all aspects of drug development or manufacturing lifecycle and works to support the Upjohn product portfolio.

The Manager, Regulatory Affairs CMC, Upjohn is responsible for:

  • Serving as CMC representative on a core project(s), managing project activities, assessing regulatory risks & development plans to develop global regulatory strategies for programs in accordance with regulatory, scientific & technical criteria.

  • Managing regulatory issues, maintaining submission information in relevant CMC systems, tracking regulatory commitments & timelines for specific projects/products/markets with minimal supervision.

  • Presenting and articulating issues for resolution, communicating regularly with key stakeholders to ensure alignment, providing consultation as a scientific/technical resource for assigned projects, mentoring and sharing experience with colleagues.

  • Authoring and/or coordinating CMC activities for new registrations, post approval changes, renewals, annual reports and line extensions to meet filing requirements. Coordinating & contributing to responses to Agency queries and performing quality review of regulatory CMC submissions.

  • Serving as a technical and scientific resource and providing guidance for completion of difficult and complex projects.

  • Prioritizing & independently completing assigned workload appropriately.

  • Developing effective relationships with local & global internal partners, i.e., R&D, PGS, Country Regulatory Leads, other CMC lines.

  • Developing relationships with regulatory authorities to improve Pfizer's regulatory success.

  • Executing training related activities (e.g. compliance-related, HR policies) & individual development plans, participating in cross-disciplinary forums & learning opportunities, engaging in Straight Talk & Listen exchanges, demonstrating & modeling adherence to all Pfizer behaviors & values, embracing & complying with Principles of Integrity.

  • Managing and contributing to CMC-related projects, initiatives & actions.

  • Participating, as required, in pharmaceutical industry conferences or serving externally as a representative to pharmaceutical trade group advisory committees relevant to CMC functions.

  • Mentoring colleagues within focused area of expertise.

How to apply

Make a difference today, all suitable candidates should apply though the link with CV provided. We are looking forward to hear from you!

Additional Detail

  • In order to be considered for this position you need to be legally eligible to work in Ireland.

  • Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Due to high volume of applications we will be contacting successful candidates only.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.