Regulatory Affairs Specialist Prague, Praha

Regulatory Affairs Specialist

We are (COMPANY NAME)
Home to the worlds 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
About the role
Regulatory Affairs Specialist is responsible for delivering the regulatory and compliance program for selected (COMPANY NAME) Hygiene products, leading to the growth of the CZ and SK business. To work to ensure on-time delivery of registrations and notification for Hygiene products. Regulatory Affairs Specialist is a key partner to a Regulatory & Safety Manager in developing the right portfolio strategy for brilliant innovation and activation in our markets.
Regulatory Affairs Specialist 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.
**Responsibilities**:
- Deliver all activities related to the implementation of regulatory and product safety strategies for (COMPANY NAME) Hygiene products within the CZ and SK business.
- Works independently at RB Regulatory Excellence Project as required by (COMPANY NAME) (project oriented to improving quality of dossier
submitted to Regulatory bodies related to regulated Hygiene products).
- Responsibility for preparation and coordination of regulatory submissions and strategies.
- Actively cooperates with Regulatory & Safety Manager CZ/SK regarding projects as per agreed timelines.
- Work collaboratively with the Regulatory & Safety Manager CZ/SK to maintain and improve current product portfolio of regulated Hygiene products.
- Cooperate on the resolution of regulatory issues affecting the relevant products and provide advice to Regulatory & 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 Hygiene 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 & 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 were looking for
- 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.
- Fluent in English
- Minimum 2 years experience working within a Regulatory Affairs environment either in pharmaceutical company, FMCG Company (local or international) or Governmental or laboratory environment.
- Basic Excel
- Strong communication skills
- Strong project planning and estimating skills related to area of expertise
- Ability to develop, communicate and execute regulatory strategy for advancing (COMPANY NAME) 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 (COMPANY NAME)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 (COMPANY NAME)s pay for performance philosophy.
Equality
We recognise that in real life, great people dont always tick all the b

Zajímavé nabídky práce v okolí: