Regulatory Affairs Manager CEE
1 dzień temu
Job Title: Regulatory Affairs Manager CEE
Job Summary:
We are seeking a highly skilled Regulatory Affairs Manager CEE to lead our regulatory strategy development and execution for CIS and non-EU CEE countries. The successful candidate will be responsible for managing the entire registration process, including new product approvals, manufacturing and import permits, and product amendments.
Key Responsibilities:
- Develop and execute regulatory strategies to ensure timely and high-quality submissions.
- Manage the registration process, including new product approvals, manufacturing and import permits, and product amendments.
- Support distributors in interactions and negotiations with Health Authorities, driving an agenda to create a favorable regulatory environment.
- Provide strategic direction to the business, aligning regulatory strategies with business needs and goals.
- Maintain and manage regulatory files, documentation, and corporate electronic databases, ensuring compliance and up-to-date records.
Requirements:
- At least 5 years of experience in a similar role, preferably in Regulatory Affairs.
- Fluency in Russian and proficiency in English.
- Strong understanding of regulatory frameworks, especially within the CIS – including Eurasian Economic Union framework - and non-EU CEE countries.
- Excellent communication and negotiation skills, with the ability to build effective relationships with Health Authorities and other stakeholders.
- Proven ability to manage complex projects and coordinate cross-functional teams.
- High level of organization, attention to detail, and ability to work independently.
What We Offer:
- A competitive compensation package with bonus structure and extended benefit package.
- A hybrid work culture that allows for flexibility and work-life balance.
- Opportunities for professional growth and development, including feedback loops and personalized career paths.
- A collaborative and inclusive work environment that values diversity and promotes a sense of belonging.
Next Steps:
- If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
- The next step is a virtual conversation with the hiring manager.
- The final step is a panel conversation with the extended team.
About Us:
At Galderma, we value what every member of our team brings. We believe in professionalism, collaboration, and a friendly, supportive ethos that allows people to thrive and excel in what they do.
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