Senior Manager, Regulatory Affairs
Employment Type: Full-Time
Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne's broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on Twitter, LinkedIn and Facebook.
The Senior Manager, Regulatory Affairs will help drive forward our regulatory strategy and operational activities related to Dyne's muscle disease programs. A successful candidate must thrive working in a fast-paced environment where flexibility, accountability and fearless innovation are key. Additionally, this individual must have excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to help analyze complex issues to develop relevant and realistic regulatory and strategies. A shared passion for Dyne's mission to bring transformative therapies to people living with serious muscle diseases is a must. This individual should be a creative, resourceful, integrative thinker for a role that is responsible for regulatory activities related to Dyne clinical development programs.
Primary Responsibilities Include:
* Work with the Director, RA to develop regulatory strategies for assigned projects or product(s) aimed at achieving marketing authorization and appropriate product labeling
* Support the development of cross functional strategic plans and tactical implementation leading to the creation and submission of Regulatory documents, e.g., INDs, CTAs, MAAs NDA/BLAs
* Participate in regulatory agency meetings for assigned products including meeting planning and ensuring submitted documents are compliant and of the highest quality. This includes working with the RA Director to develop, prepare and manage the content and timelines for meeting requests, briefing books, etc.
* Compile, review, approve and submit clinical trial and marketing registration applications, amendments, and supplements
* Interact cross functionally to provide proactive guidance to program teams based on technical and regulatory knowledge.
* Lead regulatory sub-teams to meet development program objectives
* Manage and ensure compliance with all reporting requirements, including annual and periodic reports
* Provide guidance for and author applications related to designations for expedited programs (e.g., Fast Track, Breakthrough, Priority) or special status (e.g., Orphan)
* Support and participate in the development of Regulatory Department systems and processes
* Perform Regulatory Intelligence activities by monitoring the development of new regulatory requirements/guidance documents and advise product teams of the impact on the business or development programs
* Perform other duties as required, interfacing with other departments, CROs and external vendors as needed
Education and Skills Requirements:
* Minimum of a bachelor's degree in life science or related discipline is required
* Minimum of 3-5 years of experience in regulatory strategy preferably in a clinical-stage biotechnology company
* Strong experience with CTD format and content regulatory filings
* Experience and in the preparation of major regulatory submissions and supportive amendments or supplements
* Experience in preparing for Health Authority Meetings
* Knowledge of EU and international regulations related to the clinical, nonclinical, and CMC development a plus
* Ability to work independently to manage multiple projects in a fast-paced environment
* Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each program's critical regulatory milestones
* Outstanding communication skills (verbal and written), regulatory writing skills and willingness to share knowledge and lessons learned
* Ability to effectively communicate the regulatory risks, mitigations, and overall plans to Project Teams and senior management
* 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 plans, programs and recommendations
* Demonstrated ability to operationalize complex regulatory strategies
* Ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks
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.