Associate Director / Senior Regulatory Affairs CMC

h2Innovative Biopharmaceutical Company | Northwestern Switzerland /h2 pstrongShape the Global Regulatory Strategy for Innovative Small Molecule Therapies /strong /p pOur client is an innovative, research-driven biotechnology company advancing a portfolio of novel small molecule therapies through late-stage clinical development. /p pAs the organization prepares for pivotal development milestones and future marketing applications, we are looking for an experienced Regulatory Affairs CMC professional who combines strategic thinking with hands-on regulatory expertise across clinical development and registration. /p pThis position offers the opportunity to become a key member of the Regulatory organization and to play an important role in future regulatory leadership. /p hr pstrongYour Responsibilities /strong /p ul liDevelop and execute global Regulatory Affairs CMC strategies across clinical development and registration programs. /li liLead and coordinate CMC regulatory activities from clinical development through marketing application. /li liPrepare, review and drive high-quality Module 3 documentation for global regulatory submissions. /li liSupport and coordinate IND, IMPD, CTA, NDA and MAA submissions. /li liRepresent Regulatory Affairs CMC in multidisciplinary project teams. /li liProvide strategic regulatory guidance throughout product development, technical changes and lifecycle planning. /li liPrepare and support interactions with regulatory agencies including FDA, EMA and other Health Authorities. /li liCollaborate closely with CMC Development, Pharmaceutical Development, Manufacturing, Analytical Development, Quality and external development partners. /li liEvaluate regulatory risks and contribute to overall development strategy. /li /ul hr pstrongYour Profile /strong /p ul liDegree in Pharmacy, Chemistry or another Life Science discipline. /li liSeveral years of experience in Regulatory Affairs CMC within biotech or pharmaceutical development. /li liProven experience supporting clinical development programs through late-stage development and registration. /li liDemonstrated experience with IND, IMPD, CTA, NDA and/or MAA submissions. /li liStrong expertise in CTD Module 3. /li liExperience interacting directly with regulatory agencies such as FDA and EMA. /li liSolid background in small molecule development. /li liExcellent communication skills with the ability to influence multidisciplinary project teams. /li liFluent English. /li /ul hr pPreferred Experience /p ul liExperience supporting first marketing applications. /li liExperience in innovative biotech environments. /li liExperience working with outsourced manufacturing organizations and external development partners. /li liScientific background combined with pragmatic regulatory thinking. /li liPrevious exposure to global development programs from Phase I through registration. /li /ul hr pstrongWhat You Can Expect /strong /p ul liA highly visible strategic role within an innovative biotechnology company. /li liDirect involvement in global development and registration activities. /li liClose collaboration with experienced scientific and regulatory leaders. /li liBroad responsibility with significant influence on development strategy. /li /ulbrpgloorlang THE RIGHT CHOICE IN CONSULTATION FOR LIFE SCIENCE TALENTS /p