- Serve as an administrator for RIM and provide direct support to functional disciplines and program teams responsible for developing submission contents
- Manage day-to-day submission activities both internally and in collaboration with business partners
- Organize, archive and track Health Authority correspondences, submissions, and questions/commitments
- Partner with Regulatory Leads to provide input into scheduling and planning of submissions
- Provide project management support in generation of timelines for Regulatory interactions and submissions
- Provide document formatting and report level publishing and compilation support
- Provide insights to ensure streamlined end-to-end content generation and submission publishing process
- Maintain up-to-date guidance knowledge and industry standards to ensure all regulatory submissions are compliant and effective to HA reviewers
- Develop and maintain Standard Operating Procedures, training materials, and job aids
- Support in maintaining content repositories for external collaboration, project management, regulatory intelligence
- Participate in change management activities in building optimal usage of the regulatory systems
- Foster collaborative relationship with business partners and manage contracts, budgets and invoices as needed
- Perform other regulatory related duties as assigned
Education and Skills Requirements: - Minimum of a BA/BS degree
- Minimum of 8 years of experience in eCTD/submission publishing and Regulatory Operations, preferably in a clinical-stage biotechnology company
- Able to display excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic regulatory operation strategies
- Able to demonstrate flexibility and accountability and identify potential issues and mitigate risks
- Thorough knowledge in eCTD, validation criteria, data standards, submission standards and requirements
- Experience with document formatting and authoring templates
- Knowledge in authoring and publishing in Veeva RIM. Experience in Business or System Administrator is a plus
- Experience in RIM process and question/commitment tracking
- Experience in compiling both US and ex-US submissions
- Experience with change management and validation of GxP computerized systems
- Experience with managing consultants and partners
- Able to proactively support and consult colleagues for guidance and training in business process, EDMS, and submission standards, as necessary
- Able to work with strategic deadlines and adapt quickly to changing requirements and priorities
- Attention to detail
- Embrace Dyne's core values and culture
- Excitement about the vision and mission of Dyne
#LI-Onsite
The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law. -
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Associate Director, Regulatory Operations - Waltham, United States - Dyne Therapeutics
Description
Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD).
Role Summary:
This role is accountable for managing the submission activities and supporting development of Regulatory Operations practices. The Associate Director of Regulatory Operations is responsible for the assembly, publishing, and submission of regulatory filings to global Health Authorities (HA) in an efficient and timely manner. This role will drive efficiencies in both submission and RIM activities with creative thought process to support improvements and long-term vision of the group.
This role is based in Waltham, MA without the possibility of being a remote role. Applicants must be able to relocate to the area.
Primary Responsibilities Include:
