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Regulatory Affairs Associate, Health

Want to see your expertise recognised? As a Regulatory Affairs Associate, Health you’ll have the freedom to influence decisions that shape our next generation of leading brands.

 

Regulatory Affairs Associate, Health

Soborg, Hovedstaden

 

 

Critical for driving innovation and optimising our product portfolio strategy, you’ll help us navigate a complex regulatory environment. Globally. You’ll ensure we remain compliant and continue to deliver the highest quality products. You’ll act as a steward for our brands. You’ll track, interpret and anticipate legislation and ensure we make smart decisions for the future. Your ideas will ensure our new products continue to make people’s lives better.

 

Responsibilities: 

 

  • Work collaboratively with the relevant Global teams and Country Commercial teams to implement the regulatory strategies within agreed timescales to bring competitive advantage to Reckitt brands. 
  • Ensure on-going regulatory and product safety compliance of Reckitt's existing product portfolio within the assigned Category segment(s).
  • Implement regulatory strategies that enable the delivery of a pipeline of product innovation to meet country requirements. 
  • Ensure compliance and perform impact assessment in relation to regulatory requirement such as EU directives, e-commerce and local legal requirements for promotional material and artwork. 
  • Understand and apply the Reckitt processes and procedures as necessary. 
  • Maintain and report on agreed key performance indicators.
  • Maintain Regulatory databases, documentation and electronic archives.
  • Support Deputy Quality Management Representative (Kvalitetsansvarlig)
  • Responsible for the Regulatory Affairs Nordic Medical product dossiers.

 

Deputy QMR:

  • Implementation of current GDP legislation incl. Danish Legislation (BG on Distribution at lægemidler, Vejledning I GDP for lægemidler til humant brug, BG om udlevering af lægemiddelprøver) and maintenance of the overall QM System within Reckitt Health Nordics.
  • Handling all quality issues including ensuring that Reckitt Health Nordics handles medical products according to current GDP-guidelines and legislation.
  • Support the recall team consisting of the QMR, CMH and SCD and is responsible for managing product recall situations. 
  • Ensure that the current valid SOPs and WIs related to their area always are available for the employees. 

Qualifications: 

 

Education: University Science degree, ideally in a relevant Scientific discipline 

 

Experience: 1-2 years of experience from the pharmaceutical industry or health authorities

 

Language skills: Fluency in English and one of Nordic languages (both oral and written) 

 

Other requirements: 

  • Experience in the OTC market and within an FMCG environment, or within a pharmaceutical environment desirable
  • Experience in biocides, devices and cosmetics regulations highly desirable
  • Knowledge of regulatory and healthcare systems in Scandinavian Region
  • Possesses excellent working knowledge of regulatory environment and processes in local markets 
  • Clear and logical thinker with the ability to recognize patterns and develop innovative solutions 
  • Pro-active self-direction with a high level of initiative and persistence and a very hands-on approach to results delivery 

 

You’ll succeed because… 

…you’re degree qualified in a scientific discipline. You excel in a fast-paced environment. You’ve an understanding of the new product development cycle, technical documentation or global product registrations. You’re a relationship-builder who thrives in an international environment. You’ve close attention to detail and are comfortable reviewing and documenting technical information. You maintain high standards, are results-orientated and highly entrepreneurial. Like us.

 

You’ll love it because… 

…you’ll have the freedom to make a difference. You’ll put your own ideas into practice. The products you get out there will allow people to live healthier lives and have happier homes. And our dynamic, ownership-driven culture will bring the very best out of you, every day.

Equality

All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law. 


Job Segment: Medical, Healthcare

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