Back to jobs

Director, Regulatory Operations

Hybrid/Waltham

ABOUT US

There are more than 9 million immunocompromised people in the United States. Almost half a million of those represent a population that are moderately to severely immunocompromised and at highest risk for severe COVID-19, including stem cell and solid organ transplant patients as well as those with hematologic cancers.

At Invivyd, Inc., we take those numbers very seriously and we come to work each day on a mission to deliver protection from serious viral infectious diseases, beginning with SARS-CoV-2. Our proprietary INVYMAB™ platform approach combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering, designed to facilitate the rapid, serial generation of new monoclonal antibodies (mAbs).

Join an incredible team of innovators, disrupters, predictive modelers, and antibody engineers who embrace a shared sense of ownership, a passion to save lives, think boldly and creatively, take targeted risks, are unafraid of failure, and welcome change as a positive catalyst to new opportunities.

Be part of making a difference. Be part of Invivyd.

The Director will be responsible for successfully executing the daily activities required for the global marketing application submission projects, process improvement, and transition projects from planned development through completion. This position will own the Veeva Vault RIM Suite continuous improvement and assist with additional Veeva implementations. Success in this role will require a thorough and current understanding of appropriate FDA and ICH regulations pertaining to global regulatory and technical requirements for documents of all submission dossier types, including Word document format, PDF specifications, and CTD structure and compliance, with full awareness of a global environment, and a robust knowledge of regulatory information management systems. While this person will work on a cross-functional team, they will be a team of one and must be comfortable rolling up their sleeves and performing all levels of tasks.

Responsibilities:

  • Responsible for leadership, accountability, and oversight for active programs and projects with a proven understanding of IND and lifecycle management for all submission types as they pertain to internal and external commitments that include submission planning, timelines, document preparation, global submission activities, and archival processes.
  • Proven leadership and expertise in all aspects of formatting, publishing, version control, and quality control of Word and PDF documents during draft and final document team reviews with full knowledge of global document specifications per ICH and FDA guidance.
  • Lead Veeva RIM Suite continuous improvement and roll-out to cross-functional teams.
  • Author job aids with step-by-step tasks and processes associated with document approvals, workflows, searching, archiving, commitments, running reports, submission tracking, metrics, and additional aspects of the capabilities of the Veeva RIM Suite platform.
  • Provide Regulatory Operations User requirements and recommendations during auto releases and out of cycle configurations.
  • Lead SOP updates that align with auto releases, configurations, and process improvement updates.
  • Lead issue and resolution management with Users and Veeva Managed Services.
  • Provide Regulatory Operations leadership during the implementation process of Veeva PromoMats in preparation for eCTD submissions to OPDP.
  • Encourage and maintain a strong interface with Regulatory staff, facilitating and prioritizing the development of compliant submissions. 
  • Works through complex situations across functional areas and identifies issues that may delay timelines while recommending appropriate action through strategic decisions and recommendations
  • Sets clear objectives and consistently delivers while demonstrating full accountability for functional area results.
  • Assist Regulatory Operations with financial and budgeting support for annual and long-range planning
  • Provide expertise while participating in assigned corporate leadership initiatives in various aspects of business process improvement.

Requirements:

  • Bachelor’s degree and/or Master’s degree with a minimum of 10 years relevant experience in pharmaceutical/biotechnology Regulatory Operations and project management
  • Proven leadership oversight for IND and lifecycle management
  • Expert skills in MS Office Suite, Adobe Acrobat and plug-ins and Veeva RIM Suite
  • Must have superior quality control document review skills for Word and PDF with the ability to identify, communicate, and train on inconsistencies that align with Invivyd's processes
  • Precise document tracking management over multiple products is essential for success in this role
  • Must be detail-oriented, decisive, and capable of influencing individuals and managing teams while demonstrating leadership, flexibility, and strong communication and negotiation skills in a fast-paced environment with constant change and diversity
  • Proven leadership on overall operational planning, coordination, and support of compliant submission dossier publishing activities with the ability to development and manage publishing timelines for the compilation of submission and maintenance of regulatory filings
  • Articulate with strong analytical, ethical decision-making, sound judgment, problem solving, and interpersonal skills while communicating with internal and external stakeholders
  • Must have the ability to present a positive and professional image through communication and interaction with key stakeholders, including colleagues, customers, vendors, and appropriate regulatory authorities, with the adeptness to work autonomously and effectively manage time to deliver results within defined
    timelines
  • Proven success in demonstrating leadership style that incorporates independent decision making, technical proficiency, creativity, and collaboration with team members
  • Knowledgeable in financial planning that defines FTE, contracts, and fees assumptions

At Invivyd we strive to create a welcoming and inclusive environment. Here all applicants will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics.

Invivyd is proud to be an equal opportunity employer.

We do not accept unsolicited resumes from agencies. 

 

We do not accept unsolicited resumes from agencies. 

Apply for this job

*

indicates a required field

Resume/CV

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf


Select...
Select...
Select...

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 Invivyd’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

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.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, 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?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

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.