Regulatory Manager, CMC MSRs and PREPs

Basic qualifications:

  • Proven experience in managing a regulatory medium-size team that successfully delivered outputs to time and quality over a sustained period,
  • Proven experience in regulatory submissions across the product lifecycle,
  • Experience of operating within a complex organization,
  • Excellent interpersonal, influencing and communication skills, together with the professional credibility to build influential cross-functional and multi-national relationships at a senior level,
  • Effective communication in local language and English,
  • Chemistry, pharmacy or closely related science degree,
  • Strong sense of urgency, able to effectively prioritize such that key issues or emerging high priority matters are handled in a timely and effective way,
  • Service-oriented attitude and ability to interact effectively with all levels of personnel in an interdisciplinary and matrix environment,
  • Ability to implement new processes and quality initiatives.

Preferred qualifications:

  • Knowledge of resource management tools/techniques,
  • Ability to self-manage the schedule of work, adapting to changing priorities and circumstances through a disciplined and logical work style,
  • Coaching skills in order to help in team members development process,
  • Negotiation and problem-solving skills, ability to identify risks before they emerge,
  • Multitasking skills, overseeing and prioritizing multiple activities across sites for multiple customers.

Details:

GSK is deeply committed to professional and personal development offering employment opportunities across a diverse collection of businesses and geographies. So you'll flourish in an inspiring environment where personal growth plays a vital part in the changing face of the business. Most of all, you'll enjoy the sense of purpose that comes from leading change in an industry that touches millions every day.

Global Regulatory Platform and Delivery (GRPD) in GlaxoSmithKline is a regulatory affairs function which brings together the operation and execution aspects for key regulatory deliverables such as new chemical entity and product expansion dossiers, labeling outputs, license maintenance and lifecycle management dossiers and regulatory information management. GRPD provides regulatory support across the product lifecycle for pharmaceutical products (clinical development to market maturity).

Regulatory Manager, CMC Market Specific Requirements (CMC MSRs) and Programme for Registration of Established Products (PREPs) is reporting to GRPD Poznan Head and is accountable for managing the team responsible for delivering assigned regulatory outputs for global markets in line with existing business needs, strategies, goals and objectives in order to support GSK's existing and new product licences worldwide.

As a Regulatory Manager you will:

  • Manage responsibilities for direct reports,
  • Be accountable for on-time and quality delivery of teams' assigned regulatory activities,
  • Liaise with customers within GRPD as well as external to GRPD,
  • Be responsible for managing resource to accommodate workload demands via agreed processes and tools,
  • Be responsible for tracking and reporting on team performance against key indicators,
  • Be responsible for understanding regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products globally,
  • Be responsible for maintaining appropriate organizational networks,
  • Be responsible for delivery of the following behaviours: customer driven, flexible thinking, continuous improvement,
  • Be responsible for identifying risks and proposing solutions for risks associated with regulatory deliverables.

Closing date for applications: 30/09/2017

When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above. Thank you for your interest in this opportunity. The information that you have provided in your cover letter and CV will be used to assess your application.

Please note that interviews for these roles will commence from ASAP, due to the short recruitment period we would appreciate your flexibility in attending interviews asap.

Contact information:

You may apply for this position online by selecting the Apply now button.

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