Regulatory Affairs Manager CEE

2 tygodni temu


Warszawa, Mazovia, Polska Galderma Pełny etat

About the Role

We are seeking a highly skilled Regulatory Affairs Manager to lead our regulatory strategy development and execution for CIS and non-EU CEE countries. As a key member of our team, you will be responsible for ensuring timely and high-quality submissions, managing the entire registration process, and providing strategic direction to the business.

Key Responsibilities

  • Develop and execute regulatory strategies for CIS and non-EU CEE countries.
  • Manage the registration process, including new product approvals, manufacturing and import permits, and product amendments.
  • Support distributors in interactions and negotiations with Health Authorities.
  • Provide strategic direction to the business, aligning regulatory strategies with business needs and goals.
  • Maintain and manage regulatory files, documentation, and corporate electronic databases.

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 and non-EU CEE countries.
  • Excellent communication and negotiation skills.
  • Proven ability to manage complex projects and coordinate cross-functional teams.

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.

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 diversity and inclusion and believe that our diverse team is the key to delivering better outcomes for our customers. We offer a dynamic and supportive work environment that allows our employees to thrive and excel in their careers.



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