Regulatory Affairs & Safety Associate

Pracovní nabídka

About the role

Regulatory Affairs & Safety Associate is obliged to deliver the regulatory and compliance program for selected Reckitt Health products, leading to the growth of the CZ and SK business. To work to ensure on-time delivery of registrations and notification for Health products. He/she is a key partner to a Regulatory Affairs & Safety Manager in developing the right portfolio strategy for brilliant innovation and activation in our markets. Regulatory Affairs & Safety Associate normally receives little instruction in day-to-day work, general instruction on new assignment from manager and independently establishes methods and procedures for attaining specific goals and objectives.

Your responsibilities

• Deliver all activities related to the implementation of regulatory and product safety strategies for Reckitt Core products within the CZ and SK business,
• Works independently at Reckitt Regulatory Excellence Project as required by Reckitt (project oriented to improving quality of dossier submitted to Regulatory bodies related to regulated Health and Personal Care Reckitt products),
• Responsibility for preparation and coordination of regulatory submissions and strategies,
• Actively cooperates with Regulatory Affairs & Safety Manager CZ/SK regarding projects as per agreed timelines,
• Work collaboratively with the Regulatory Affairs & Safety Manager CZ/SK to maintain and improve current product portfolio of regulated Health and Personal Care Reckitt products,
• Cooperate on the resolution of regulatory issues affecting the relevant products and provide advice to Regulatory Affairs & Safety Manager CZ/SK on registration and regulatory compliance issues,
• Provide regulatory affairs support and consultancy to internal stakeholders within the CZ and SK business in a professional way,
• Provide regulatory support to quality functions to ensure Core Products are maintained in compliance with local requirements,
• Work closely with external partners, authorities, inspections, local trade associations, distributors, contractors to ensure that regulatory affairs issues are properly managed and resolved,
• Approval of artworks and promotional materials from regulatory point of view,
• Keep record of the documents, maintain regulatory database,
• Assist the Regulatory Affairs & Safety Manager CZ/SK and Regulatory Director Poland & EE and Global and Local Functions to implement Company regulatory, safety & environmental policies, guidelines and procedures,
• Other tasks assigned by manager.

The experience we're looking for

• Fluent in Czech/Slovak and English
• Educated to honors degree level in Pharmacy, Chemistry, Biological Science or equivalent degree,
• Ability to understand and interpret directives and regulatory guidelines and communicate them effectively to the relevant stakeholders,
• Ability to deliver consistently under pressure, adhering to cost, time, and quality standards.
• Minimum 2 years experience working within a Regulatory Affairs environment either in pharmaceutical company, FMCG Company (local or international) or Governmental or laboratory environment.
• Commercially aware, adept at building partnerships and proposing improvements to enhance business processes.
• Capable of embracing change and setting clear objectives in line with our business goals.
• Degree in a scientific field with a robust understanding of global regulatory environments impacting consumer products.
• Experience in dossier creation, submission, and product lifecycle management.
• A track record of reviewing and authoring high-quality documents.
• Familiarity with the regulatory requirements for medical devices in the EU (MDR) and US (510k) would be beneficial.
• Basic Excel

Nice to have:

• Strong communication skills
• Strong project planning and estimating skills related to area of expertise
• Ability to develop, communicate and execute regulatory strategy for advancing Reckitt growth in close alignment with Regulatory initiatives.
• Contributes to increasing business results by addressing needs of the customers.
• Participates in developing new products, line extensions and product improvements.
• Acts on opportunities to improve the business and willingly takes risks. Enjoys the challenge of unfamiliar tasks, open to change, analyses both successes and failures for clues to improvement, learns quickly when facing new problems, intellectually curious, pragmatic.

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.