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Senior Regulatory & Safety Associate

City:  Budapest

We are Reckitt

Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose.
Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.

​Research & Development​

You will work on the front line of Hungarian regulations, undertaking the activities required to meet the Reckitt Business needs as per defined priorities set by the regulatory management, and ensuring product compliance with all local regulations and Reckitt internal processes.

About the role

As Senior Regulatory & Safety Associate you’ll lead and undertake tasks from medical and safety perspectives and the regulatory actions related to them regarding Reckitt products necessary to meet the needs of the Reckitt Benckiser business in Hungary. You will help drive growth of the business by maintaining safe, effective and competitive products in the markets. In this position you will report to the Regional Regulatory Affairs and Safety Manager, and will be based in Budapest.

 

In this role you will: 

 

  • Ensure that promotional materials have the most up to date and SmPC compliant claims, and that these materials meet high standard of copy approval in line with the regional advertising codes of practice
  • Help drive growth of our Health business by creating and maintaining safe, effective and competitive claims and products in the markets
  • Communicate expert knowledge and the science behind our brands to various business partners within and outside Reckitt, ensure claim competitiveness and support product credibility and endorsement
  • Monitor, collect and interpret regulatory, medical issues/local trends in the OTC advertising legislation, that will impact Reckitt products, policies and procedures, share this information with appropriate local and global functions and assist in the development of strategies and plans of action to address them 

Your responsibilities

  • Submit or work with Regulatory Team to submit and document all Safety Reports to the Competent Authority
  • Interface with relevant government agencies, industry associations
  • Provide advice and training on our products and therapeutic areas to the local business
  • Provide technical input for sales and marketing campaigns
  • Check the medical marketing materials against the local legislation and the latest approved SmPC/technical documentation
  • Ensure compliance with local Pharmacovigilance, Medical Device Vigilance and Cosmetovigilance guidelines
  • Ensure up to date knowledge of the local regulatory legislation / requirements
  • Ensure that the National Business Unit has a 24-hour number set up to allow adverse event reports and enquiries to be dealt with by an appropriately qualified service outside normal office hours
  • Collect local adverse events from all sources and report properly within assigned reporting timelines, and undertake appropriate follow up

The experience we're looking for

  • University Science degree in a relevant Scientific discipline, ideally in Pharmacy or Medicine
  • Experience in the OTC market within an FMCG or pharmaceutical environment, with experience in a Medical, Regulatory and/or Safety function
  • Experience or understanding of Drug Safety on a local level
  • Fluent English and fluent Hungarian
  • Ability to handle competing priorities and issues resolution effectively
  • Sound performer in interacting with regulatory authorities
  • Proactive approach with the ability to take ownership
  • Ability to effectively manage projects and relationships with local partners, contractors, and consultants

The skills for success

Regulatory Affairs, Safety, Pharmacovigilance, OTC products, Pharmaceutical Industry, Business Acumen, Commercial Awareness, Accountability. 

What we offer

With inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way.
We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitt's potential future successes. For eligible roles, we also offer short-term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt's pay for performance philosophy.

Equality

We recognise that in real life, great people don't always 'tick all the boxes'. That's why we hire for potential as well as experience. Even if you don't meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you.
All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; 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 Device, Pharmacovigilance, Counseling, Nutrition, Pharmacy, Healthcare

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