Regulatory Affairs Manager CEE

1 miesiąc temu

Warsaw, Polska Galderma Pełny etat

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

Job Title: Regulatory Affairs Manager CEE & CIS

Location: Warsaw (hybrid)

Job Description

We are looking for a highly skilled Regulatory Affairs Manager to join our team in Warsaw, Poland. You will drive and execute all Regulatory Affairs priorities for Galderma's product classes (medicinal products, injectable medical devices, cosmetics) across distributor markets in CIS (e.g. Kazakhstan, Azerbaijan, Uzbekistan, Georgia) and non-EU CEE (e.g. Albania, Serbia, Bosnia-Herzegovina, Ukraine) countries . In this role, you will collaborate closely with distributors, service providers, and agents to ensure compliance and facilitate market access.

Key Responsibilities

  • Lead regulatory strategy development and execution for CIS and non-EU CEE countries, ensuring timely and high-quality submissions.
  • Manage the entire 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.

Skills & Qualifications
  • 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 in return
  • You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.
  • You will receive a competitive compensation package with bonus structure and extended benefit package
  • You will be able to work in a hybrid work culture
  • You will participate in feedback loops, during which a personalized career path will be established
  • You will be joining a growing company that believes in ownership from day one where everyone is empowered to grow and to take on accountability

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

Our people make a difference

At Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.

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