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Regulatory Affairs Manager

We are looking for a Regulatory Affairs Manager to join our team in Budapest. In this role you will report to the Regulatory Affairs Senior Manager SEE&EU and your will be responsible for a team of two.

 

You’ll have the following key responsibilities:

  • Manage all regulatory work related to Reckitt’s Health Business Unit’s products
  • Ensure compliance with all local regulations and with company Regulatory, Safety and Environmental policy, guidelines and procedures
  • Ensure the registration and regulatory compliance of locally marketed products
  • Proactively lead the development and implementation of strategies to ensure regulatory compliance efforts
  • Interface with local government agencies and industry associations to assess the impact and implementation of required company compliance with all regulations, laws and industry policies that affect the ingredients, packaging, marketing, advertising, labelling and production of our products
  • Being member of the local regulatory associations to have updated information and knowledge of the local and EU regulatory requirements and legislation

  • Represent Company interests with local government agencies, industry associations and/or other organizations
  • Develop and maintain a database of local regulatory requirements
  • Provide regulatory and product compliance expertise in the area of advertising and label claims for existing and new products. Regulatory approvals for marketing promotional materials for healthcare products in Hungary.
  • Manage and supervise the process of developing artworks for healthcare products for Hungary
  • Assist in the organization of internal audits and monitor audits performed by 3rd parties
  • Maintain and report measures of product registration and regulatory compliance performance
  • Obtain the authority permissions (final sample permission, special permission etc.) necessary to place the healthcare products on the market
  • Prepare, maintain and update local product registration and regulatory compliance files

You’ll succeed because you have:
 

  • University or College degree in Pharmacy, Chemistry, Biology, Bioengineering or related discipline
  • Minimum 5 years of experience in managing product registration and regulatory compliance functions in a consumer-oriented industry (ideally pharmaceutical)
  • Prior experience in product registration
  • Proven track record of interacting with Hungarian regulatory authorities
  • Fluent English besides native Hungarian
  • Great negotiation, analytical and influencing skills, efficient priority setting
  • Commercial, marketing and consumer understanding

We offer:

  • Modern and friendly office located in the 11th district
  • Regular home office opportunity and flexible working hours
  • Attractive benefits package: cafeteria, free entrance in 2 gyms, products discounts, shortened working days on certain Fridays
  • Being empowered to take responsibility and work independently
  • Continuous learning and self-development possibilities

 

You’ll love it because… 

…you’ll get to make an impact like never before. The products you get out there will make people’s lives better. Our iconic brands will provide an incredible platform for you. And our dynamic, ownership-driven culture will help 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, Pharmacy, Healthcare

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