Regulatory Manager, Submission Coordination
Brentford, Middlesex
1d ago

As Regulatory Manager, Submission Coordination , you will be accountable for leading and managing the team responsible for delivery of Rx and Vx submissions for marketed products to agreed timeframes and appropriate content in compliance with Regulatory Authorities regulations, guidance’s and with GSK SOPs and working practices, and in line with existing business needs, strategies, goals and objectives.

You will cooperate with internal and external stakeholders according to agreed ways of working, priorities and deadlines to ensure delivery of overall departmental objectives.

You will be reporting to the Established Products, Submission Coordination Head.

As the Regulatory Manager you will :

  • manage people aspects of a team of direct reports to create and sustain an efficient and motivating working environment,
  • support submissions for marketed Pharma and Vaccines Products by timely delivering high quality applications (right first time),
  • ensure high standard of submissions,
  • identify risks to quality and / or timely completion of project, resolving any issues and escalating items to be resolved at a higher management level,
  • drive continuous process improvement within areas of your influence,
  • monitor regulatory intelligence and act proactively on identified changes to regulatory requirements,
  • take accountability for tracking, analyzing and reporting of team performance against departmental KPIs.
  • build and maintain quality relations with your internal and external stakeholders,
  • work closely with your peers and Established Products Submission Head to drive standardization across the business.
  • Basic qualifications :

  • Documented track of relevant experience in Regulatory Affairs,
  • Bachelor’s or Master's degree in biotechnology, pharmacy, chemistry or other related science or technical field,
  • Capability to build, motivate and maintain a team,
  • Fluent Polish & English (verbal and written),
  • Strong interpersonal and communication skills,
  • Ability to perform multiple tasks, set the right priorities to deliver objectives on time,
  • Adapting to changing circumstances through priorities reassessment and a disciplined, logical work style,
  • Sound understanding of the pharmaceutical industry and regulatory processes,
  • Project Management experience.
  • Preferred qualifications :

  • well-developed leadership skills,
  • negotiation and problem solving skills,
  • practical knowledge of risk management,
  • adapting to changing circumstances through priorities reassessment and a disciplined, logical work style.
  • We offer :

  • Important, established and interesting job in one of the leading global healthcare companies.
  • Possibility to work with engaged and enthusiastic people from various locations.
  • Opportunity to work in a professional team, playing crucial role in supporting GSK portfolio worldwide
  • Access to newest technologies and solutions.
  • Possibilities of development within the role and company’s structure.
  • Attractive reward package (annual bonus, awards for outstanding performance, rewards and recognition programme, private medical healthcare, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance).
  • Personalized learning approach (internal trainings, mentoring, access to online training’ platforms : Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training).
  • Extensive support of work life balance (flexible working solutions, remote work, short Fridays option, health & well-being activities).
  • Supportive community and integration events.
  • LI-Hybrid

    If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

    GSK is an Equal Opportunity / Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity / expression, age, disability, genetic information, military service, covered / protected veteran status or any other federal, state or local protected class.

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