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Regulatory Affairs Manager/DSO

City:  Kyiv

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.

About the role

As a Regulatory Affairs Manager & DSO at Reckitt, your regulatory expertise becomes a pivotal part of our business's success. In this role, you won't just be part of the process — you'll lead it, making strategic decisions that influence the direction and achievements of our brand. Enhance your career by working in a space where your insights impact our footprint, and your initiative shapes our industry presence. If you're ready to see your regulatory acumen translated into tangible business outcomes, we're looking for you.

Your responsibilities

  • Maintaining the system for collecting, assessing, and submitting data on adverse reactions and lack of efficacy in Ukraine. 
  • Ensuring the implementation of necessary pharmacovigilance and product safety measures in accordance with national legislation, the corporate Vigilance Agreement, and Standard Operating Procedures (SOPs). 
  • Interaction with the national regulatory authority and Risk Management & Vigilance to ensure timely submission of pharmacovigilance reports, risk management plans, and other safety information regarding medicinal products. 
  • Implementing safety-related variations for medicinal products, and liaising with regulatory authorities regarding registration, re-registration, or safety amendments. 
  • Drafting texts for product labeling and instructions for the medical use of medicinal products in accordance with regulatory requirements. 
  • Reviewing and approving advertising and promotional materials for medicinal products in compliance with regulatory requirements. 
  • Participating in the approval process of color layouts (AWs) for the instructions accompanying the medicinal product, as well as reviewing and approving AWs of other packaging elements. 
  • Analyzing changes in Ukrainian legislation and corporate procedures concerning pharmacovigilance, medicinal products, medical devices, and cosmetics, and implementing these changes into practice.

The experience we're looking for

  • Degree in pharmaceutical or medical field
  • At least 2 years of experience in pharmacovigilance and regulatory affairs
  • Experience in maintaining a pharmacovigilance system
  • Fluent Ukrainian and
  • Solid grasp of regulations, with a knack for interpreting their impact and implementing them innovatively. 
  • Proven communication skills, able to manage relationships with stakeholders and cross-functional teams. 
  • A record of delivering results and adapting to new information and challenges. 

The skills for success

Pharmacovigilance, Commercial awareness, Accountability, Consumer insight, Collaboration and partnership building.

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, Healthcare

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