Regulatory Sciences Manager CMC

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 ResponsibilitiesPrepare and review pharmaceutical quality documentation including CTD Modules 2.

3 & 3, IMPDs, and ASMFsProvide strategic regulatory advice to clients on pre- and post-approval topicsConduct due diligence and gap analysis of legacy products and in-licensing opportunitiesPrepare and submit marketing authorisation applications and variations, and respond to regulatory deficiency lettersCommunicate effectively with regulatory authorities, manufacturing sites, API suppliers, and QC laboratoriesSupport technology transfer projects from a regulatory affairs perspectiveMonitor regulatory changes and ensure alignment with evolving requirementsFoster strong client relationships through reliable execution and regulatory insightQualificationsDemonstrated experience within the pharmaceutical industry, ideally in Regulatory Affairs, Manufacturing, Quality, or Product DevelopmentStrong understanding of the pharmaceutical product lifecycle and regulatory requirementsProven track record of preparing high-quality documentation for regulatory submissionsConsistently delivers work with precision, accuracy, and reliabilityExcellent communication skills with the ability to collaborate across all levels of the organizationAbility to transfer knowledge effectively and support colleagues through structured, educational approachesFluent in English, with strong written and verbal skillsWillingness to travel for client engagements and collaboration with other ProPharma sitesPositive mindset and strong team-oriented approachSelf-driven, with initiative and sound decision-making within established frameworksSkilled at managing multiple projects simultaneously while meeting deadlines and maintaining high standardsEducationBSc Degree in Life Sciences (preferred)ExperienceMinimum 3 years of relevant experience in regulatory affairsPrior exposure to client-facing roles in a consultancy environment is a strong advantageWe 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. ***