Senior Consultant Regulatory Affairs

ProPharma Group; Deutschland; Vor Ort; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

A leading consulting firm, ProPharma Group, seeks a Senior Regulatory Consultant to enhance regulatory excellence across Europe and Emerging Markets. The role entails providing strategic regulatory guidance, managing registration applications, and liaising with health authorities, requiring strong communication and project management skills.

Qualifikationen

• Strong verbal and written communication skills in English and German.
• 5+ years of extensive experience in regulatory affairs.
• In-depth knowledge of regulatory requirements and submission processes.

Aufgaben

• Provide strategic regulatory guidance and ensure compliance.
• Coordinate and compile registration dossiers for marketing authorization applications.
• Manage and oversee the creation and maintenance of product information texts.

Kenntnisse

Communication

Project Management

Regulatory Knowledge

Detail Orientation

Ausbildung

MSc Degree in Life Sciences

Jobbeschreibung

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.

We're seeking a talented Senior Regulatory Consultant to join our Regulatory Operations Group, where your expertise and meticulous attention to detail will ensure regulatory excellence across Europe and Emerging Markets.

Key Responsibilities

• Provide strategic regulatory guidance by interpreting country-specific regulations to ensure compliance and mitigate risks.
• Coordinate and compile registration dossiers for marketing authorization applications in EU (CP, DCP, MRP) and non-EU markets, with a focus on Module 1.
• Prepare and author lifecycle management applications (renewals, variations), including Module 1 documents.
• Assess and classify variations in alignment with EU and non-EU regulatory frameworks.
• Independently manage and oversee the creation and maintenance of product information texts (SmPC, PIL, labeling) and artwork globally, including translations.
• Serve as the key liaison with health authorities, addressing submission-related queries.
• Represent Regulatory Affairs in cross-functional initiatives, fostering alignment between departments.
• Demonstrate strong project management skills to ensure efficient workflows and timely regulatory submissions.
• Maintain exceptional attention to detail and accuracy in all regulatory documentation and compliance activities.

Requirements & Skills

• Strong verbal and written communication skills in English and German (mandatory).
• MSc Degree in Life Sciences (essential)
• 5+ years of extensive experience in regulatory affairs within the pharmaceutical or biotech industry, preferably in a consultancy role with global responsibilities.
• In-depth knowledge of regulatory requirements and submission processes across multiple regions.
• Proven expertise in coordinating EU (CP, DCP, MRP) and non-EU registration procedures.
• Exceptional project management capabilities and a proactive approach to problem-solving.
• High level of accuracy and attention to detail in regulatory documentation.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***