Regulatory Affairs OHC Specialist, Export Markets CIS

3 Hours ago • 2 Years +

Job Summary

Job Description

The Regulatory Affairs OHC Specialist will manage regulatory affairs for products within CEE Export Markets, specifically in the CIS countries, ensuring compliance for medicines, medical devices, cosmetics, and food supplements. Responsibilities include preparing regulatory documents, ensuring timely product launches, approving product labeling, analyzing regulatory issues, building stakeholder relationships, and managing promotional materials. They also proactively manage the impact of regulatory changes and maintain regulatory databases. The role requires collaboration with various teams to achieve business goals.
Must have:
  • University degree in a related science field.
  • Minimum 2 years of experience in Regulatory Affairs.
  • Understanding the environment of CIS countries.
  • Fluent written and verbal communication in English and Russian.
Good to have:
  • Planning and organization skills.
  • Strategic thinking.
  • Negotiation skills.
  • Innovative thinking.
Perks:
  • Annual bonus and awards for outstanding performance.
  • Extensive support for work-life balance and flexible working solutions.
  • Private medical package for employees and eligible counterparts.
  • Personalized learning approach for continuous growth.
  • Supportive community that values collaboration and inclusivity.

Job Details

Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question.

Regulatory Affairs Oral Health Care Specialist, Export Markets CIS

About the role

As a Regulatory Affairs OHC Specialist you will be responsible for Regulatory Affairs in defined portfolios or activity streams within CEE Export Markets, for the CIS countries. You will ensure products within scope (including medicines, medical devices, cosmetics and food supplements) can be placed on the market with optimal yet compliant claims, advertising and promotion in line with commercial plans.

You will be part of defined local regulatory team, including being a proactive partner to other stakeholders, e.g., marketing/sales within local commercial business, supply chain and quality etc. You will engage with the external regulatory environment within defined area of responsibility and act as a responsible voice of Haleon with local bodies. You will work together with regulatory colleagues and other stakeholders to proactively look for opportunities and solutions to challenges.

Role Responsibilities

  • Manage preparation of new regulatory documents, dossiers and applications to enable new products to be launched and maintained in market, with the correct alignment and compliance to regulations, proactively seeking innovative and rapid path to market.

  • Ensure the deadlines for product launch, new product application and variations submissions are kept.

  • Approve the products labelling/artwork in line with Haleon and local legislation requirements.

  • Manage labelling text and packaging components to ensure compliance with local registered details and corporate prescribing information. 

  • Analyse regulatory issues and communicate with key stakeholders. Work together to help develop plans to mitigate, so we can deliver science that is robust and aligned with business needs.

  • Build relationships with key stakeholders and represents Haleon in an appropriate manner according to company values.

  • Work together with other functions (e.g., marketing, supply chain) to deliver NPD and value engineering projects.

  • Check and approve promotional and advertising materials, ensuring that materials comply with Haleon and local requirements.

  • Obtain necessary approvals from competent authorities for the promotional and advertising materials before dissemination in a timely manner. Respond to authority’s comments, offer supporting evidence and argumentation for our claims, in order to obtain timely approval.

  • Proactively manage impact of regulatory changes within defined scope of responsibility on the business.

  • Maintain required regulatory compliance databases, systems and processes.

  • Employee is responsible for providing the necessary support, intelligence and adherence around all Quality driven activities to ensure that function/department performance is in accordance with agreed processes.

Why you?

Basic Qualifications:

  • University degree in Life science/Pharmaceutically related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering).

  • Minimum 2 years of experience in Regulatory Affairs including medicines, cosmetics, medical device or food supplements.

  • Understanding the environment of CIS countries.

  • Fluent written and verbal communication in English and Russian.

Preferred Qualifications:

  • Planning and organization skills.

  • Strategic thinking.

  • Negotiation skills.

  • Innovative thinking.

Please upload your resume in English.

Please save a copy of the job description, as this may be helpful to refer to once the advert closes.

What we offer?

Haleon offers a dynamic hybrid work model, allowing you to achieve a balance between professional and personal life. Enjoy an attractive reward package that includes an annual bonus, awards for outstanding performance, and recognition for additional achievements and engagement. We prioritize your well-being by providing extensive support for work-life balance, offering flexible working solutions, including the possibility of working from home, and engaging in various health and well-being activities. Our commitment to diversity is reflected in our open and inclusive environment, which welcomes individuals of all backgrounds, embracing diversity in gender, race, ethnicity, sexuality, disability, and any other characteristic. As part of our commitment to your health, we provide a private medical package for both employees and their eligible counterparts. Our personalized learning approach ensures continuous growth and development in your professional journey. Join a supportive community that values collaboration and inclusivity and take part in integration events that foster a sense of belonging.

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.

Care to join us. Find out what life at Haleon is really like www.haleon.com/careers/

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Accommodation Requests

If you require a reasonable 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 accommodations you are requesting. We’ll provide all reasonable accommodations to support you throughout the recruitment process and treat all information you provide us in confidence.

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About The Company

Hello. We’re Haleon. A new world-leading consumer healthcare company. Shaped by all of us. Together, we’re improving everyday health for millions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re building together. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us.

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