Our commitment to people with muscle diseases
is our greatest strength

Director, Regulatory Operations

Department: 130 Regulatory

Location: Waltham, MA

Company Overview:

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 TwitterLinkedIn and Facebook.

Role Summary:

Dyne Therapeutics is searching for a creative, fearless innovator, to join the Dyne Family. This role is accountable for leading the regulatory publishing operations group, is the first hire and will report into the Head of Regulatory. The Regulatory Publishing Director is responsible for the creation, assembly, and publishing of electronic submissions and the delivery to global health authorities in an efficient and timely manner. The Director of Regulatory Operations will also be responsible for document management related to filing and archiving of submissions and correspondence to FDA. This Role will be responsible for quality driven and timely execution of submissions as well as 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:

  • Provide vision and road map specific to regulatory informatics & submissions
  • Initiate strategic plan for implementation of an electronic document management and publishing system to support global regulatory authority requirements
  • Partner with Global Regulatory Leads to provide input into scheduling and planning of submissions
  • Provide global regulatory guidance regarding regulatory operation requirements for clinical development and registration of pharmaceuticals
  • Oversee preparation, review and submission of regulatory documents maintaining compliance with regulatory requirements
  • Archive Health Authority communications and tracking of questions and commitments
  • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
  • Provide regulatory project management of timelines and preparation of meeting requests and briefing documents
  • Support and partner with IT, Regulatory, Medical Writing and cross-functional team members to ensure compliance with submission standards and processes
  • Prepare documents for submission as needed (document level publishing)
  • Assist with SOP generation as needed

Education and Skill Requirements:

  • BA/BS Degree
  • 6-8 years of eCTD Publishing and/or Regulatory Operations experience in a biotech/pharmaceutical industry
  • Must thrive working in a fast-paced environment, where fearless innovation is a core value
  • Demonstrate flexibility, accountability, and drive toward the mission
  • 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 
  • Demonstrated ability to operationalize complex regulatory strategies
  • Ability to clearly communicate and to resolve complex issues and mitigate risks
  • Extensive experience with Sharepoint, Microsoft Word, Adobe Acrobat, and electronic publishing software
  • Experience using electronic document management systems.
  • Thorough knowledge of CTD/eCTD format and regulatory submission requirements.
  • Experience compiling IND, NDA, and other CTD submissions.
  • Strong team player that has a customer service approach and is solution oriented.
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
  • Embrace our core values
  • Excitement about the vision and mission of Dyne

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.


Apply for this Job

* - required fields





Attach File or Paste

Attach File or Paste








Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in this company’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.



If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.


Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.



BACK | NEXT