Regulatory Affairs and Safety Associate RO&BG

This job is with Reckitt, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
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.

In Research and Development, we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance.

We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.

The size of our organisation means you'll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.

About The Role
As a Regulatory Affairs and Safety Associate RO&BG, you're at the forefront of shaping the synergy between our innovative products and the regulatory framework that guides them.

You will be responsible for implementing regulatory practices in the defined categories (OTC products). By adhering to global standards and local procedures, you will contribute to providing safe, effective and compliant products to customers, consumers and patients, as well as accurate and consistent information to internal and external stakeholders. You will be responsible for registration, labeling and implementation of regulations applicable to OTC products in Romania and Bulgaria.

Your responsibilities

• Responsible for all aspects of filing registrations and maintaining documentation compliance throughout the product life cycle
• Exercises the necessary authority to prepare and submit documents and product files for approval/authorization/notification to the appropriate agencies
• Collaborate with relevant local and global teams and the commercial teams in Romania and Bulgaria to establish and implement regulatory strategies within the agreed timeframes to execute the business plan for the commercialization of OTC medicine products
• Coordinate the resolution of regulatory issues affecting OTC products, advising the company on registration and regulatory issues
• Provide regulatory support and advice to internal and external clients in the region in a professional manner
• Collaborate closely with external partners, contractors and licensees to ensure that regulatory issues are properly managed and resolved
• Collaborate with the team while taking on independent responsibility for regulatory innovation and compliance activities
• Interpret and implement regulations and guidelines as needed to foster industry compliance
• Engage with trade associations, contributing to and utilising our resources to influence favourable legislation
• Understand the regulatory necessities of diverse projects, actively participate in them, and remain alert to project advancements and their benefits
• Manage updates and actions in your area, ensuring tasks are completed effectively and efficiently

The experience we're looking for

• University degree preferably in Pharmacy or Medicine
• At least 2-3 years of experience in Regulatory Affairs
• Fluent in Romanian and English
• Results-oriented, entrepreneurial and self-motivated
• Proficient in multitasking, executing tasks under pressure, and making objective decisions when faced with complex issues
• Acute business acumen accompanied by commercial awareness
• Demonstrated ability to cultivate insights from consumer interactions and translate them into strategic actions
• Skilled in collaborating with teams across various functions, fostering an environment of partnership building
• Agility to adapt to the ever-evolving technological landscape, complemented by a mindset that seeks to improve and advance current processes

The skills for success

Regulatory Affairs, Safety, Business Acumen, Commercial Awareness, Accountability, Collaboration and partnership building, Adapt to changes in technological development plans, Task execution under pressure.

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.