Pfizer Team Leader Regulatory Affairs CMC in Little Island, Ireland

The Closing date for applications is Tuesday 26th February 2019

The Team Lead, Regulatory Affairs CMC, is an emerging senior level position, recognized as an expert for global CMC regulatory knowledge and quality expertise. The position is primarily devoted to development of strategic CMC regulatory approaches to expedite the preparation and review of regulatory submissions in support of the Upjohn product portfolio.

The scope of this role requires the following skills and competencies:

  • A recognized technical subject-matter expert with extensive relevant regulatory experience & business knowledge.

  • A leader and strategist capable of leading interactions with regulatory agencies for assigned projects and programs.

  • Develops & advocates CMC regulatory & quality policies & provides regulatory leadership, guidance & support to project teams.

  • Exercises independence in judgment and decision-making to influence regulatory & business strategy, guide complex projects with broad impact and balance risk with organizational flexibility & business needs.

The Team Lead, Regulatory Affairs CMC, is accountable for:

  • Working within cross-functional project teams to develop and provide global robust regulatory strategies for assigned Upjohn products and therapeutic portfolios, leveraging both technical and regulatory knowledge to mitigate risk.

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

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

  • Leveraging connections to contribute to global regulatory submissions, strategies, policies & risk assessments

  • Delivery of high quality regulatory submissions & submission management plans.

  • Endorsing execution of regulatory policies and implementation of operational processes for delivering the product portfolio.

  • Managing a team of colleagues

The Team Lead, Regulatory Affairs CMC, is responsible for:

  • Cultivating sustainable & effective relationships across a network of stakeholders, partners and customers to drive and establish aligned approaches to regulatory strategies and/or policies.

  • Interpreting CMC regulatory requirements, developing strategies (including novel approaches), assessing risks and developing contingency proposals.

  • Using technical and scientific knowledge in the preparation and analysis of CMC submission documentation and maintenance of product compliance and management of CMC change control.

  • Ensuring all CMC regulatory activities are executed effectively & efficiently, and in compliance with external regulatory requirements & internal quality procedures.

  • Serving as a liaison with regulatory agencies for specific topics and providing oversight for the fulfillment of agency commitments and providing responses to agency queries.

  • Providing guidance & direction to direct reports, managing resources & resource capacity along with prioritizing workload appropriately.

  • Accomplishing performance-management & training related activities, encouraging & supporting a healthy work/life balance, supporting roll-out of HR policies, recruiting & hiring vacancies, providing guidance & facilitating opportunities for talent development, encouraging colleague participation in cross-disciplinary forums & learning opportunities, engaging colleagues in Straight Talk & Listen exchanges, demonstrating & modeling adherence to all Pfizer behaviors & values, embracing & complying with Principles of Integrity.

  • Presenting and articulating issues for resolution, communicating regularly with key stakeholders to ensure alignment, providing consultation as a scientific/technical resource within the department/cross-functional and therapeutic teams for assigned projects, mentoring and sharing experience with colleagues.

  • Managing, leading and contributing significantly to Upjohn projects and initiatives within cross-functional project teams.

  • Serving on governance & steering committees

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.