Senior Manager, Regulatory Operations (Lexington)
Employment Type: Full-Time
Industry: Non-Executive Management
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This Senior Manager, Regulatory Operations role is responsible for various day-to-day functions related to document publishing, regulatory information management, and submission management among other tasks as required. Under the direction of the Senior Director, Regulatory Operations, this individual will support various regulatory application types including INDs, NDAs, MAA, CTA and related amendments/supplements in eCTD format. The individual is accountable for being knowledgeable of and for monitoring global systems guidance, technology specifications, identifying process/system impacts and ensuring system updates to meet the current requirements. Works under consultative direction supporting the Regulatory Management Team toward long range goals and departmental objectives. Demonstrates expert technical, project management and communication skills.
- Partner with the Senior Director in leading NDA and MAA eCTD submission preparation and publishing activities.
- Electronic document publishing, scheduling and coordination of various document complexities (clinical protocols/amendments, nonclinical reports, SAPS, CSRs, related regulatory documentation, etc.)
- Support various internal functional groups ensuring the compliant use of eCTD Authoring Templates
- Primary user of Adobe Acrobat, 3rd-party plugins, eCTD Authoring Templates and related tools as required
- Ensure tracking and archiving of regulatory filings, correspondence and related information for various regulatory applications
- Perform U.S. and international regulatory research tasks as related to Regulatory Technology and Operations
- Attending internal team meetings to collect and organize potential upcoming publishing and submission tasks
- Participate in Regulatory initiatives aimed at improving internal regulatory standards, systems and procedures
- Works with internal project team members in the selection, development, testing, validation, training, implementation and ongoing support of business systems.
- Identify resource plans in support of projects and coordinate user testing needs in support for new system and maintenance releases.
- Prepare training materials and conduct training of user personnel in the use of systems and on-going system updates.
- Manage the development, authoring and implementation of SOPs for new system implementations and system updates.
- Provides expert technical guidance within Regulatory and to other functional areas on regulatory processes, systems and electronic regulatory submissions.
- BA/BS in science discipline 7 years of biopharmaceutical regulatory experience.
- Strong technical skills in current publishing software and document management systems.
- Experience in publishing multiple global regulatory submissions including but not limited to IND, IMPD, CTAs, Agency Briefing Packages, DMF, NDA, SPL Labelling, and MAAs.
- Excellent understanding of ICH, Part 11, Annex 11 and related requirements.
- Experience managing resources and various GxP systems.
- Experience managing and mentoring staff.
- Attention to detail.
- Ability to work independently with minimal supervision.
- Positive attitude, energetic and proactive.
- Proven ability to manage multiple projects.
- Strong interpersonal skills and the ability to effectively work with other departments and vendors.
Karyopharm Therapeutics Inc. (the "Company") is an equal opportunity employer.All qualified applicants will be considered without regard to age, race, color, sex, religion/creed, national origin, marital status, ancestry, citizenship, military, reservist or veteran status, pregnancy, sexual orientation or preference, gender identity, gender expression, physical or mental disability, genetic predisposition or carrier status, or any other category protected under applicable federal, state or local law.Consistent with its obligations under applicable law, the Company will make reasonable accommodations for qualified individuals with disabilities.If you require an accommodation in the application process, please contact a member of the Companys Human Resources department.
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