Senior Director, Regulatory Information Management
2 weeks ago
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:
The Senior Director, Regulatory Information Management role is accountable for developing and implementing the strategy and processes for regulatory information management as well as global marketing application readiness and planning. The person in this role develops the process, tools and systems needed to build a core dossier for global marketing application submissions, and liaises with global counterparts and key internal stakeholders to develop strategic and tactical plans for global dossier planning capabilities globally. This role is expected to apply subject matter expertise in regulatory information and submission management to lead and identify opportunities, shape objectives and drive execution of key functional and corporate objectives.
This role is based in Waltham, MA without the possibility of being a remote role.
Primary Responsibilities Include:
Develop and implement the strategy for operationalizing simultaneous marketing application filings in multiple countries including assessing resourcing and budget needs
Partner within regulatory, medical writing, project management and across functions to plan, develop, and manage marketing applications from a regulatory operations perspective
Provide support planning, and tracking of timelines for global regulatory interactions and submissions
Provide solutions and support for the visualization of regulatory tasks and timelines
Provide insights to ensure streamlined end-to-end content generation and submission publishing processes
Partner with IT to assess current regulatory systems/technology and develop a plan for optimization and/or implementation of new systems/technology as needed
Maintain up-to-date knowledge of guidance, regulations, and industry standards to ensure all regulatory submissions are compliant with current standards globally
Participate in change management activities to optimize use of regulatory systems
Foster collaborative relationship with business partners and manage contracts and budgets as needed
Perform other regulatory related duties as assigned
Education and Skills Requirements:
Minimum of a BA/BS degree
10+ years of experience in Regulatory Operations with eCTD/submission publishing experience in a clinical late stage and/or commercial biotechnology company
Experience implementing and utilizing various outsourcing and support models
Leadership experience managing cross-functional teams with an ability to influence teams to prioritize activities and allocate resources without direct authority
Excellent written and oral communication skills, including well-developed presentation skills
Excellent organizational skills and ability to manage multiple priorities
Strong collaboration and interpersonal skills to effectively interact with internal or external stakeholders at all levels in the organization
General business management knowledge to assess the impact of project decisions on financial and corporate objectives
Expertise in global regulatory filing project management
Expertise in Global Health Authority submissions and requirements and guidelines
Ability to drive timelines, meet firm deadlines, and adapt quickly to changing requirements and priorities
Demonstrated flexibility and accountability and ability to identify potential issues and mitigate risks
Thorough knowledge in eCTD, validation criteria, data standards, submission standards and requirements
Advanced experience in Veeva RIM
Experience with change management and validation of GxP computerized systems
Ability to proactively support colleagues with guidance and training in business process, EDMS, and submission standards, as necessary
Very high 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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