Regulatory Affairs Manager CEE

1 tydzień temu

Warszawa, Mazovia, Polska Galderma Pełny etat

Description

Key Responsibilities

  • Take the lead in developing and executing regulatory strategies for CIS and non-EU CEE countries, ensuring timely submissions of high quality.
  • Oversee the entire registration process, including approvals for new products, manufacturing and import permits, and product amendments.
  • Assist distributors in engaging and negotiating with Health Authorities, pushing for a conducive regulatory atmosphere.
  • Offer strategic guidance to the business, aligning regulatory strategies with its needs and objectives.
  • Organize and oversee regulatory files, documentation, and company databases, ensuring compliance and updated records.

Skills & Qualifications

  • Minimum of 5 years of experience in a similar role, preferably in Regulatory Affairs.
  • Proficiency in Russian and English.
  • In-depth knowledge of regulatory frameworks, particularly within the CIS and non-EU CEE regions, including the Eurasian Economic Union framework.
  • Outstanding communication and negotiation skills, fostering effective relationships with Health Authorities and other stakeholders.
  • Demonstrated ability to manage complex projects and coordinate multi-disciplinary teams.
  • Exceptional organizational skills, attention to detail, and capacity to work autonomously.

What We Offer in Return

  • You will be part of a diverse and inclusive organization that believes in leveraging diverse perspectives for better outcomes.
  • Competitive compensation package with bonus structures and comprehensive benefits.
  • Opportunity to work in a hybrid work environment.
  • Engagement in feedback sessions to establish personalized career progression paths.
  • Joining a growing company that emphasizes ownership from day one, empowering everyone to grow and take on responsibilities.

Next Steps

  • If your profile aligns, you will be invited for an initial virtual meeting with the recruiter.
  • Subsequently, a virtual discussion with the hiring manager will follow.
  • The final stage involves a panel conversation with the extended team.

Our People Make a Difference

At Galderma, you will collaborate with a diverse group of individuals who bring unique perspectives. We appreciate the contributions each team member makes, fostering a professional, collaborative, and supportive environment where everyone can thrive and excel.

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