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Regulatory Affairs Manager CMC

Company: Hays
Location: Durham
Posted on: August 5, 2022

Job Description:

Regulatory Affairs Manager CMC - Perm - Durham, NCThe end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.An American Company is seeking a Regulatory Affairs Manager CMC in Durham, NC.Role DescriptionReporting to the Director, Regulatory Affairs and Clinical Sciences, the Manager, Regulatory Affairs will support the company's regulatory affairs strategies needed for IND/CTA/BLA/NDA filings and approvals in North America, Asia-Pacific (outside China) and EU. The Manager, Regulatory Affairs is a key member of project teams and is responsible for the managing the day-to-day tasks required to achieve regulatory goals across multiple programs. The Manager, Regulatory Affairs is expected to bring knowledge of the clinical development process and regulatory requirements, strong project management and vendor management skills, and excellent communication and writing skills to ensure that company submissions meet regulatory and company standards with high quality and within stated timelines.--- Interacts with vendors to submit applications and reports to applicable regulatory agencies within established timelines and with high quality standards--- Coordinates cross functionally to assist with the organization of regulatory applications and reports--- Manages company systems to ensure accurate documentation of all regulatory submissions--- Supports the maintenance of active INDs/CTAs in compliance with all relevant regulations--- Provides support to the department by ensuring that designated structures and systems are maintained appropriately--- Assists with regulatory research, literature searches, and safety narrative writing projects--- Supports the leadership team during interactions with FDA, Health Canada, EMA and other relevant regulatory agencies and bodies with meeting setup, minute preparation, and action item tracking--- Supports the implementation of new regulatory strategies, processes and SOPs.--- Develops strong relationships with team members internally and at contracted regulatory vendors, ensuring positive interactions and driving shared commitments--- Reviews and approves regulatory vendor invoices--- Performs other related duties, as assignedSkills & Requirements--- Bachelor's degree in the life sciences with 7+ years relevant experience; or post-graduate degree with 2+ years of relevant experience.--- CMC Regulatory experience is a plus.--- Strong organizational, problem solving, and project management skills--- Excellent written and verbal communication skills--- Ability to balances a sense of urgency with adherence to quality--- Strong leadership skills and understanding of cross functional interactions--- Strong professional research and writing skills--- Some international and domestic travel may be requiredWhy Hays?You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.Nervous about an upcoming interview? Unsure how to write a new resume?Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.Hays is an Equal Opportunity Employer including disability/veteran.In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570Drug testing may be required; please contact a recruiter for more information.

Keywords: Hays, Durham , Regulatory Affairs Manager CMC, Executive , Durham, North Carolina

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