Job: Associate Director Regulatory Affairs, CoImmune Inc., Durham, NC
Associate Director Regulatory Affairs
Durham, NC 27704 United States
Serves as CoImmune's internal representative for regulatory activities related to development, manufacturing and licensing of biologic products. Serves as primary or secondary regulatory interface with Clinical, Manufacturing, Development, QA, QC and external regulatory partners to ensure alignment and compliance with local, regional and global registration requirements, as well as with company policies. Provides supervision to other regulatory personnel.
• Identification and assessment of regulatory risks associated with product development and strategies to mitigate risks.
• Acts as direct liaison with regulatory authorities to facilitate prompt review and approval of applications.
• Responsible for regulatory activities pertaining to required disciplines (e.g. CMC, clinical).
• Coordinate and prepare organized and scientifically valid regulatory documentation for clinical applications within
• Provide regulatory guidance within the company.
• Assist other groups as necessary with qualification, validation and product comparability documentation which meet
• Review of change control documentation for regulatory impact.
• Write and edit Module 1, 2, 3, 4 and/or 5 documents according to CTD guidelines.
• Prepare components of regulatory briefing packages.
• Provide responses to regulatory agency comments and questions.
• Manage contractors/consultants as assigned and ensure activities are completed according to timelines.
• Maintain up to date knowledge of regulatory requirements and communicate updates within the company.
• Prepare for and assist with regulatory inspections.
• Assist with the selection, development, training and evaluation of Regulatory Department personnel.
• Other duties as required.
• PhD or MS degree, preferably in life sciences, with minimum of 10 years' experience in the biopharmaceutical industry or
equivalent education and experience.
• Extensive experience preparing components of INDs, CTAs, and BLAs.
• Expert knowledge of the CTD format and content.
• Experience in scientific advice process with at least one regulatory authority (e.g. FDA).
• Proficiency in GCP, GLP, GMP and GTP regulations and expert proficiency in at least a subset of regulations (e.g. GMP
regulations and CMC related ICH guidelines).
• Experience participating in GxP inspections by regulatory authorities.
• Experience with cell therapies or, at a minimum, other classes of biologics or specialty products within the oncology or
infectious disease therapeutic areas. Process or analytical development/validation experience a plus.
• Excellent oral and written communication skills.
• Ability to communicate successfully with the regulatory authorities.
• Strong interpersonal skills and willingness to positively connect with people.
• Ability to work successfully in a team environment and be self-motivated to drive projects and activities.
• Must meet deadlines and be adept at organizing other team members to meet deadlines.
• Proficiency in Microsoft Office Applications (Word, Excel and/or Access, PowerPoint).
• Experience with MasterControl or comparable electronic document warehousing system.
• Ability and willingness to be regularly, predictable and reliably at work.
Work is primarily sedentary in nature.
The requirements listed in this job description are representative of the management's assignment of essential function, with knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Nothing in this herein restricts management's right to assign or reassign duties and responsibilities to this job at any time. Furthermore, the job description doesn't constitute a contract of employment and CoImmune Inc. may exercise its employment-at-will at any time.
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