Regulatory Affairs Associate CIS
Job Summary
Welcome to Haleon. Were a purpose-driven world-class consumer company putting everyday health in the hands of just three years since our launch weve grown evolved and are now entering an exciting new chapter one filled with bold ambitions and enormous opportunity.
Our trusted portfolio of brands including Sensodyne Panadol Advil Voltaren Theraflu Otrivin and Centrum lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science.
Now its time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose to deliver better everyday health with humanity at the heart of everything we do. It unites us inspires us and challenges us to be better every day driven by our agile performance-focused culture.
As a Regulatory Affairs Associate for CIS countries you will ensure regulatory compliance across markets manage submissions and approvals maintain regulatory documentation and collaborate with authorities and cross-functional teams to support successful product launches and maintaining product registrations.
In this role you will report to Regulatory Affairs Lead CEE Export market.
At Haleon you will have the opportunity to make a meaningful impact by helping ensure the availability of healthcare products that support millions of people in their everyday health.
This role offers valuable regional exposure across multiple CIS markets( Azerbaijan Turkmenistan and Georgia) allowing you to strengthen your understanding of diverse regulatory environments while developing your expertise in product registrations launches dossier management compliance and regulatory strategy.
You will work closely with experienced Regulatory Affairs professionals and collaborate with medical quality supply chain marketing and commercial teams gaining broad business exposure and influence. The role also gives you the chance to contribute to continuous improvement by identifying practical solutions to regulatory challenges and helping shape effective ways of a dynamic and strategic environment you will balance regulatory requirements business priorities compliance and speed to market while being part of a collaborative supportive and inclusive culture where expertise initiative and continuous learning are valued.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Engage with the external regulatory environment within defined area of responsibility - Azerbaijan Turkmenistan and Georgia.
Maintain the registration launch of new products in OTC&MD categories: apply regulatory knowledge in preparing submissions and ensuring compliance. Prepare and manage regulatory documents dossiers and applications to support new product launches and lifecycle maintenance across CEE Export Markets.
Obtain required market authorizations and submit new product files variations renewals notifications and updates in line with legal and business requirements.
Review and approve product labelling artwork packaging components and promotional materials to ensure compliance with Haleon standards and local regulations.
Analyze regulatory issues assess risks and work with stakeholders to develop practical business-aligned mitigation plans.
Maintain compliance across assigned portfolios including regulatory databases systems records and quality-driven processes.
Collaborate with cross-functional teams including marketing supply chain quality and regulatory colleagues to support new product development and value engineering projects. Interact with colleagues in other global functions and Regulatory Affairs to deliver high quality dossiers documents and materials to local Regulatory Affairs in accordance with business priorities.
Monitor regulatory changes maintain strong product and scientific knowledge and contribute to continuous improvement of team performance and ways of working.
Strategically achieve and maintain a balance between regulatory concerns marketing objectives time to market technology compliance and costs.
Researching analyzing and interpreting regulatory rules and guidelines
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Min. Bachelors degree in Pharmaceutical or Life science/Pharmaceutically-related science (Chemistry Pharmacy Biochemistry Biology Medical Engineering)
Fluent written and verbal communication in English and Russian
Experience in Regulatory Affairs role min 1-2 years (preferably region: EAEU nonEAEU CIS) from pharmaceutical/consumer health products environment
Skilled in scientific interpretation/evaluation/communication of technical information; dossier management
Proficiency and familiarity with databases
Ability for analyzing and evaluating laws and regulations that apply to the process of determining the impact on company activities
Critical thinking proactive reliable/executive &decision making results driven abilities
Well-developed analytical skills and the ability to pay particular attention to details
Excellent written and oral communication and interpersonal skills to frequently work with other employees and team members remotely
Significant multitasking skills and the ability to manage competing priorities
Ability to work with multiple stakeholders across planning quality supply chain marketing and wider cross-functional teams
Flexible mindset and the ability to search for information using available resources
Significant organizational time management skills and ownership of follow-up actions
None of us should ever feel like we are standing still. Instead we want Haleon to be a place where we feel like we are always progressing. Improving everyday health takes dedication. Energy. Effort. So we look to reward your contribution with a benefits package that includes:
Besides the base salary we provide annual bonus based on individual and company performance
Cafeteria flexible benefits package including preventative health programs
Employee assistance program
Hybrid work
Haleon Global Parental Leave Global Caregiver Leaveand Global Volunteer Leave
Haleon rewards your contribution with a benefits package depending on each CEE locations. More detailed information will be disclosed at a further stage of recruitment process depending on a location.
Location this role is primarily based in: Budapest Hungary
Additional location: Warsaw/Poland Kiev/Ukraine Almaty/Kazakhstan
This position is a grade: 8
Please save a copy of the job description as this may be helpful to refer to once the advert closes.
#Li-hybrid
HUF - HUF The salary range for this position is indicative and provided as a guide. The final offer may vary depending on factors including relevant experience skills qualifications and internal equity considerations. Further details regarding the total reward and benefits package will be shared during the recruitment process. Salary ranges may vary by location in line with local market conditions and applicable pay transparency regulations. Compensation information is shared for the primary location of this role. Where the position is advertised with additional locations the compensation range will be discussed during the recruiting process.Job Posting End Date
Haleon are committed to mobilising our purpose in a way that represents the diverse consumers and communities who rely on our brands every day. It guides us in creating an inclusive culture where different backgrounds and views are valued and respected all in support of understanding and best serving the needs of our consumers and unleashing the full potential of our people. Its important to us that Haleon is a place where all our employees feel they truly belong.
During the application process we may ask you to share some personal information which is entirely voluntary. This information ensures we meet certain regulatory and reporting obligations and supports the development refinement and execution of our inclusion and belonging programmes that are open to all Haleon employees.
The personal information you provide will be kept confidential used only for legitimate business purposes and will never be used in making any employment decisions including hiring decisions.
If you require a reasonable adjustment or accommodation or other assistance to apply for a job at Haleon at any stage of the application process please let your recruiter know by providing them with a description of specific adjustments you are requesting. Well provide all reasonable adjustments to support you throughout the recruitment process and treat all information you provide us in confidence.
The Haleon recruitment team will contact you using a Haleon email account (@). If you are not sure whether the email you received is from Haleon please get in touch.
Required Experience:
IC
About Company
About us We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.