Regulatory Affairs Manager – International Markets including US / Biological drugs, vaccinesExecMind is a Life Science Executive Search company connecting life sciences companies with world-class scientists and visionary leaders.
Regulatory Affairs Manager – International Markets including US / Biological drugs, vaccinesExecMind is a Life Science Executive Search company connecting life sciences companies with world-class scientists and visionary leaders.
Regulatory Affairs Manager – International Markets including US / Biological drugs, vaccinesExecMind is a Life Science Executive Search company connecting life sciences companies with world-class scientists and visionary leaders.
Regulatory Affairs Manager – International Markets including US / Biological drugs, vaccinesExecMind is a Life Science Executive Search company connecting life sciences companies with world-class scientists and visionary leaders.
Regulatory Affairs Manager – International Markets including US / Biological drugs, vaccinesExecMind is a Life Science Executive Search company connecting life sciences companies with world-class scientists and visionary leaders.
Regulatory Affairs Manager – International Markets including US / Biological drugs, vaccinesExecMind is a Life Science Executive Search company connecting life sciences companies with world-class scientists and visionary leaders.
Regulatory Affairs Manager – International Markets including US / Biological drugs, vaccinesExecMind is a Life Science Executive Search company connecting life sciences companies with world-class scientists and visionary leaders.
Regulatory Affairs Manager – International Markets including US / Biological drugs, vaccinesExecMind is a Life Science Executive Search company connecting life sciences companies with world-class scientists and visionary leaders.

We help our clients find world-class scientific talents that deliver high-quality contributions to their companies. Connecting people who have strong aptitude and passion for their work with companies that share their vision and values - this is why we do what we do.

 

 

We help our clients find world-class scientific talents that deliver high-quality contributions to their companies. Connecting people who have strong aptitude and passion for their work with companies that share their vision and values - this is why we do what we do.
 
We are looking for an experienced professional to join a regulatory team as
 
Regulatory Affairs Manager – International Markets including US / Biological drugs, vaccines


Location:  Offices in Warsaw, Lublin / hybrid mode

 

 

We are partnering with a biopharmaceutical company focused on creating biological drugs that are based on microorganisms and blood derivatives. 
Their products are distributed globally, reaching 50 countries. They aim to become a leading force in the Life Science industry, setting new benchmarks and trends. To achieve this, we are seeking an experienced individual to lead the registration department and help improve current processes. The ideal candidate should have a proven track record in developing successful strategies for entering new markets with pharmaceutical products.

 

 

Key tasks:

  •  Development and implementation of a new/optimal strategy and process for registration of a pharmaceutical products in the Polish, EU, CIS and other markets (including the US).
  • Monitoring and developing the entire product registration process, including pharmacovigilance monitoring.
  • Generating and implementing improvements to the registration process.
  • Overseeing the assessment of all registration dossiers, including reviewing and approving protocols, reports and registration documents.
  • Cooperation with appropriate external registration units in Poland, European Union or US registration authorities.
  • Conducting audits of registration processes and mitigating risks.
  • Supervision of the budget and department resources

 

 

Requirements:

 

  • MSc/PhD in medicine, pharmacy, biotechnology, biology or related fields.
  • Strong experience in registering medicinal products and a minimum of 4 years of management experience.
  • Highly preferred expertise in regulatory management.
  •  Experience in operational processes, including establishing a strategy and improving a process for registering new medicinal products (preferably biological drugs) for new markets.
  • Knowledge of pharmaceutical legislation, particularly current EMA and ICH guidelines regarding detailed registration documentation, is also required.
  • General knowledge of rules and regulations in preclinical and clinical research is a plus.
  • Ability to report post-registration changes.
  • Knowledge of license in and license out principles.
  • Knowledge of document management systems (software) and experience in implementations of such systems will be a plus.
  • Nice-to-have qualifications include knowledge of the development of medicinal products in the initial phase.
  • Excellent English coomunication skiils required.

   

We offer:

  • High level of independence and responsibility for decision-making.
  • Significant impact on the organization.
  • Work in stablished, recognizable, and growing organization with an international presence.
  • Full-time employment contract with occasional travel.
  • Preferred location: Warsaw or Lublin / hybrid work. 

 

We would be happy to discuss the career opportunities and guide you through the recruitment process.

 

Please, apply using our fast recruitment system.

 

                   

 

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