Hybrid Regulatory Sciences Manager CMC bei Propharmagroup

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