Regulatory Affairs Manager Biologicals (m/f/d), Regulatory Affairs EU/ROW

Merz Aesthetics is an independent, internationally active company in the field of aesthetic medicine.

For years, our comprehensive product portfolio is among the highest quality in its category and is valued by healthcare professionals worldwide.

Merz Aesthetics is part of the Merz Group, with our Europe , Middle East and Africa (EMEA) headquarters in Frankfurt am Main.

Our global head office is located in Raleigh, North Carolina, USA.

Our purpose is to help people look better, feel better, and live better, and over 3,000 employees across 26 countries are dedicated to this mission.

Would you like to become part of our success story?

Join Merz Aesthetics!

The following responsibilities are awaiting you

• You develop and execute regulatory strategies for new product registrations and lifecycle management activities across EU and international markets with a focus on the Asia-Pacific region.
• You provide regulatory expertise to cross-functional project teams and ensure compliance with evolving regional regulatory requirements.
• You prepare, coordinate, and submit Clinical Trial Applications (CTAs) and amendments in accordance with EU Clinical Trial Regulation (EU CTR 536/2014) and international requirements.
• You support the compilation, maintenance, and submission of high-quality regulatory dossiers for marketing authorizations and registrations.
• You manage regulatory activities related to new registrations, approval procedures, variations, line extensions, renewals, and post-approval commitments.
• You contribute to the creation, maintenance, and implementation of Company Core Data Sheets (CCDS) and product information documents.
• You coordinate and prepare responses to regulatory authority questions, ensuring timely and compliant submissions.
• You monitor global regulatory developments and assess their impact on products and development programs.
• You prepare for and participate in interactions with health authorities, including scientific advice meetings and consultations.
• You maintain regulatory databases, submission tracking tools, and document management systems.
• You collaborate closely with internal stakeholders, affiliates, partners, and external consultants to achieve regulatory objectives.
• You support inspections, audits, and other regulatory compliance activities as required.

What we expect from you

• You hold a degree in Pharmacy, Natural Sciences, or a comparable academic qualification and bring at least 2 years of regulatory affairs experience with medicinal products (biologicals) in the pharmaceutical industry in a similar role.
• You have experience with Clinical Trial Applications in the EU (EU Regulation 536/2014) and/or the registration of medicinal products in the EU through Mutual Recognition Procedures.
• You have experience with CTIS submissions, CTD compilation and filing, document filing and archiving, and are proficient in Microsoft Word, Excel, and Power Point.
• You have experience with regulatory affairs for medicinal products in ROW markets, particularly APAC countries such as China, Japan, or South Korea, and experience with Docu Bridge is considered an advantage.
• You communicate fluently in English; business fluent German and additional language skills, particularly Chinese or Japanese, are considered an advantage.
• You demonstrate a creative mindset, innovative thinking, strong communication skills, emotional intelligence, resilience, and problem-solving capabilities.
• You are highly organized and bring strong time management, prioritization, collaboration, project management, leadership, and influencing skills.

What you can expect from us

Putting people first : You can expect to find an open work culture with flat hierarchies and short decision-making paths at Merz Aesthetics.

You will collaborate with colleagues from all around the globe.

And if life takes an unexpected turn and you need help or advice, then you can always rely on our different internal and external support systems.

Family and work : Our employees should be able to reconcile their family and work commitments.

That’s why you’ll find, for example, company day care centers at our locations.

In the EMEA region, we have been awarded the “Top Employer” and “Great Place to Work” certifications for our outstanding HR policies and work culture.

Work-life harmony

Our time is precious; our daily routines individual.

To help you reconcile work and leisure time with their conflicting demands, we have adopted contemporary flexible working time models.

We offer you flex-working time and mobile working.

Our employees also benefit from generous arrangements for annual leave.

Ongoing training : Your personal and professional development is the key to success for us.

To foster this, we conduct regular development discussions and facilitate a wide range of management and specialist training courses, soft skills courses, e-learning courses, language courses and coaching sessions.

Find out more about our benefits at https://careers. merz-aesthetics. com.

We look forward to your application!

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