- Professional
- Oficina en Berlin
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.
Key Responsibilities
Prepare and review pharmaceutical quality documentation including CTD Modules 2.3 & 3, IMPDs, and ASMFs
Provide strategic regulatory advice to clients on pre- and post-approval topics
Conduct due diligence and gap analysis of legacy products and in-licensing opportunities
Prepare and submit marketing authorisation applications and variations, and respond to regulatory deficiency letters
Communicate effectively with regulatory authorities, manufacturing sites, API suppliers, and QC laboratories
Support technology transfer projects from a regulatory affairs perspective
Monitor regulatory changes and ensure alignment with evolving requirements
Foster strong client relationships through reliable execution and regulatory insight
Qualifications
Demonstrated experience within the pharmaceutical industry, ideally in Regulatory Affairs, Manufacturing, Quality, or Product Development
Strong understanding of the pharmaceutical product lifecycle and regulatory requirements
Proven track record of preparing high-quality documentation for regulatory submissions
Consistently delivers work with precision, accuracy, and reliability
Excellent communication skills with the ability to collaborate across all levels of the organization
Ability to transfer knowledge effectively and support colleagues through structured, educational approaches
Fluent in English, with strong written and verbal skills
Willingness to travel for client engagements and collaboration with other ProPharma sites
Positive mindset and strong team-oriented approach
Self-driven, with initiative and sound decision-making within established frameworks
Skilled at managing multiple projects simultaneously while meeting deadlines and maintaining high standards
Education
BSc Degree in Life Sciences (preferred)
Experience
Minimum 3 years of relevant experience in regulatory affairs
Prior exposure to client-facing roles in a consultancy environment is a strong advantage
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.***
