Head of Regulatory - Czech Republic & Slovakia

Why Haleon?

• Unprecedented opportunities
• Unique experience
• Unstoppable growth

The future of everyday health is changing, and we are the ones changing it.

Join us in what others dare not.

Build a career you'll be proud of.

About your job

GSK is a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. Our products are used by millions of people around the world, helping them to do more, feel better and live longer. For our activities we are looking for candidates for the position:

Head of Regulatory - Czech Republic & Slovakia
Job Purpose

• Leadership of Regulatory activities, strategy and compliance for pharma and vaccines product portfolios in Czech Republic & Slovakia
• The development and implementation of standardized, efficient and compliant processes across the 2 markets and support to the cluster head.
• Line management, coaching and development of a team or Regulatory staff across 2 markets
• Be an authority on the regulatory framework in Czech Republic & Slovakia (with support from local point of contact as required) and Europe to provide guidance to the local business to ensure compliance and support commercial growth

Key Responsibilities

• Lead regulatory strategy for Portfolio to underpin the Pharmaceutical business in Czech Republic and Slovakia to support competitive license approvals, market access, product launch and supply continuity.
• Leadership of regulatory affairs activities for product portfolio in Czech Republic and Slovakia to enable the delivery of business priorities and maintain highest standards of regulatory compliance and quality
• Dual reporting to cluster and LOC GMs. Advise LOC Management Teams (MT) on Regulatory matters and support MT business strategy.
• Builds, maintains and leads an efficient and well-motivated team ensuring appropriate prioritization and flexible resourcing including driving and measuring performance
• Leads the resource management, objective setting and review, development and coaching of staff.
• Ensure the development and optimization of standardized, efficient and compliant processes across the Czech Republic and Slovakia.
• Ensure compliant management of marketing authorizations.
• Ensure regulatory documentation are maintained according to internal procedure.
• Ensure local responsibilities relating to regulatory conformance are adhered to Regulatory Lead at audits and inspections
• Develop and maintain strong relationships with all key personnel within the Regulatory Agencies Local Industry groups and with key internal groups including those at a senior level in Global Regulatory, Safety and Medical.

About you

• University degree: Life sciences/pharmacy/professions aligned to medicine
• Knowledge of the policies and regulatory climate in the Czech Republic and Slovakia.
• A proven track record of effective collaboration and negotiation with regulatory agencies
• Advanced knowledge of drug development process and laws, regulations and practices affecting the pharmaceutical industry.
• The ability to recognize, anticipate and discuss potential regulatory challenges with teams in the Business and Global Regulatory.
• Strong management and project leadership skills, ability to provide advice and counsel to company staff in strategic decisions;
• The ability to make decisions/influence outcomes that include assessment of the risk and impact on the business and using good judgment regarding when to refer issues to senior management

Financial benefits

Non-financial benefits

Advertiser

Brief description of the company

Haleon Levice, s.r.o.

Stable, dynamically developing production plant in Levice , with more than 500 employees , is part of the distribution network for Haleon Consumer Healthcare . It focuses on the production of personal care products in the category of oral hygiene care. The production plant in Levice has many of the world's most popular toothpaste brands in its production portfolio, such as Sensodyne, Parodontax, Aquafresh.

Number of employees

500-999 employees

Contact

Contact person: Mgr. Ingrid Furst