What are the responsibilities and job description for the Associate Director Regulatory CMC Combination Products (remote) position at EMD?
Employer Industry : Healthcare and Life SciencesWhy consider this job opportunity : Opportunity for career advancement and growth within a diverse and inclusive working cultureWork with innovative drug-device combination products that improve and prolong livesEngage with regulatory authorities and build scientific credibility in the industryCollaborate with multidisciplinary teams across 6 continentsFlexible working environment that encourages personal developmentWhat to Expect (Job Responsibilities) : Develop global regulatory strategies for submissions and approvals of drug-device combination productsImplement regulatory strategies for drug-device combinations in clinical trial programsCollaborate with technical, development, quality, commercial, IP, and business development teams to support projectsBuild relationships with internal and external stakeholders to accelerate developmentEnsure compliant and timely execution of regulatory updates, submissions, and reporting responsibilitiesWhat is Required (Qualifications) : Degree in a Life Science or related discipline (minimum MSc or equivalent degree); higher degree preferred (e.g., PhD)Over 8 years of experience in regulatory affairs of drug-device combination products and / or medical devicesProven expertise in building global regulatory strategy and submissions dossiers for global submissionsStrong understanding of regulatory frameworks in the EU and US for combination productsFluency in English is mandatoryHow to Stand Out (Preferred Qualifications) : Proven track record of effective collaboration with regulatory authoritiesPrior experience with CMC and connected drug / device combination productsGood understanding of international regulatory frameworks such as ICH, EU-MDR, and ISO-13485Strong team player with effective communication skills across diverse backgroundsExperience in scientific advice meetings with regulatory authoritiesWe prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately.We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.#J-18808-Ljbffr
