Regulatory Affairs Manager (all genders)

Opella Healthcare Group SAS; Deutschland; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading healthcare company is seeking a Regulatory Manager in Germany to develop strategies for over-the-counter medicines and medical devices. The ideal candidate has over 3 years of experience in Regulatory Affairs for medicines in the EU, strong communication skills, and fluency in both German and English. This role offers the opportunity to work on meaningful projects in a collaborative and creative environment.

Leistungen

Challenging and meaningful work

Inclusive culture

Skill development opportunities

Qualifikationen

• Minimum 3 years in Regulatory Affairs for medicines in Germany and the EU.
• Experience with medical devices and supplements is a plus.
• Fluent in German and English, written and spoken.

Aufgaben

• Develop regulatory strategies for OTC medicines and medical devices.
• Communicate with authorities and respond to deficiency letters.
• Create and approve product information texts.

Kenntnisse

Proactive communication

Teamwork

Regulatory database proficiency

Attention to detail

Ausbildung

Degree in natural sciences (Pharmacy, Chemistry, Biology)

Tools

PC applications

Jobbeschreibung

Opella is the self-care challenger with the third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.

Our mission is to bring health in people's hands by making self-care as simple as it should be, serving half a billion consumers worldwide.

At the core of this mission are our 100 loved brands, our 11,000-strong global team, 13 manufacturing sites, and 4 innovation centers. Headquartered in France, Opella produces brands like Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale, and Mucosolvan.

We are B Corp certified in multiple markets and committed to healthier people and planet. Learn more at www.opella.com.

About the job:

• As Regulatory Manager Germany, you will actively contribute to Consumer Health Care solutions, responsible for evaluating and implementing international and local development projects and OTC switches of prescription medicines for our German CHC portfolio, from product idea to launch. You will also ensure product safety and quality through lifecycle management, advertising, and product information regulation as the information officer under § 74 AMG.

Main responsibilities:

• Develop regulatory strategies for OTC medicines, medical devices, and potentially OTC switches of prescription medicines. Collaborate with global and local teams in an interdisciplinary environment.
• Assess external registration documents (Due Diligence).
• Develop regulatory defense strategies in case of product risks.
• Plan, organize, and execute activities for drug approval applications and maintenance (national, MRP, DCP).
• Communicate with authorities, respond to deficiency letters, and conduct Scientific Advice Meetings.
• Create, review, and approve product information texts.
• Approve promotional materials, ensuring compliance as the designated information officer for specified medicines.

About you:

• Experience: Minimum 3 years in Regulatory Affairs for medicines in Germany and the EU; experience with medical devices and supplements is a plus.
• Skills: Experience with medical devices and supplements advantageous. Proactive, flexible, excellent communication and teamwork skills. Structured, diligent, business-oriented. Proficient with complex regulatory databases and PC applications.
• Education: Degree in natural sciences (e.g., Pharmacy, Chemistry, Biology); MDRA is a plus.
• Languages: Fluent in German and English, written and spoken.

Why us?

At Opella, you will undertake challenging, meaningful work, developing consumer brands with passion and creativity. Grow new skills in a bold, collaborative, inclusive culture where everyone can thrive.

Our Challenger Culture:

• All In Together: Supporting each other and maintaining honesty.
• Courageous: Breaking boundaries and taking thoughtful risks.
• Outcome-Obsessed: Being accountable and driving impact with integrity.
• Radically Simple: Making things simple for us and consumers.

Join us on our mission: Health. In your hands.

www.opella.com/en/careers