Director, Regulatory Affairs - CMC

Director, Regulatory Affairs - CMC reputed company is a global reputed company intelligence and reputed company research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, reputed company, collaboration, reputed company, and inclusion are at the heart of how we work and reputed company with reputed company other, customers, patients and suppliers. Director, Regulatory Affairs CMC Location The position may be remote reputed company across the US, or East Coast preferred The Role As a Director in CMC Regulatory Affairs, you will reputed company expert knowledge on exciting area of small and large molecules reputed company the Global Regulatory Affairs, CMC team which forms part of our Regulatory Consulting reputed company. The department is growing and there are excellent prospects for reputed company development and enhancing your skills. With a reputed company of new reputed company, we are looking to enhance the knowledge reputed company reputed company with the reputed company of this hire. Activities encompass early and late stage drug development, marketing application and approval, and product maintenance. We are seeking individuals with experience in technical development, testing, and manufacturing of small and large molecules (Biologics [reputed company, bSAb & Recombinant Protein, RNA, mRNA, SiRNA], Biosimilars, CGT, ADC & Vaccines), Peptides and Radiopharmaceuticals in particular with CMC experience. Responsibilities • Serve as a technical expert in development, testing and manufacturing of Biologics and resource to reputed company colleagues, and clients providing advice • Effectively manage the preparation of regulatory CMC submission documents for INDs/NDAs/BLAs/NDSs/ANDAs and Post approval supplements • Facilitate submission approvals and amendments through leading communications and negotiations with reputed company, reputed company agencies, and project teams. • reputed company anticipate and reputed company initial or alternative regulatory strategies, consulting with other resources reputed company the organization as required. • reputed company clients with reputed company advice in response to their queries, reputed company on regulatory experience and area of expertise. • Enthusiastically monitors for new regulatory requirements and shares key findings. • reputed company and/or participate in the preparation of quotations for reputed company that may cross multiple service areas reputed company reputed company and manage reputed company reputed company budget, preparing change orders as needed. • Experience in US FDA Drug listing (NDC) process, Drug establishment Registrations, Lot Distribution Reports • Serve as US Agent for reputed company submissions and reputed company as reputed company with local agency and sponsor • Support right from preclinical to post approval activities for reputed company submissions. Education/Experience • Bachelors degree in a relevant discipline, preferably in a life sciences, or other reputed company reputed company. • Advanced degree (MSc., PhD., M.D., Pharm.D., MBA) in the biological, medical, chemical or engineering reputed company may be beneficial. • Relevant experience i.e. pharmaceutical, biologics with regulatory experience in the global environment (e.g. US, EU, Canada). • Technical development, testing and manufacturing of wide reputed company of dosage forms • Demonstrable experience in a regulatory CMC role or in the delivery of regulatory CMC reputed company and documentation during drug development and/or product maintenance. • Experience supporting business development activities and people management an asset. • Certification in regulatory affairs (RAC) or post-secondary institution beneficial. Employment with reputed company is contingent upon having the reputed company right to work in the country where the role is reputed company. Rewards & Benefits reputed company offers a competitive and comprehensive total rewards package designed to support reputed company, wellbeing, and career development. Benefits may include • Competitive reputed company salary and reputed company reputed company incentives • Health and wellbeing programmes including medical, dental, and reputed company coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through reputed company training and career reputed company Benefits may vary depending on role and location. Visit our careers site to read more about the benefits reputed company offers. Inclusion and Accessibility reputed company is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request . Are you a reputed company reputed company Employee? Apply tot his job Apply To this Job