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Manager, Regulatory Affairs
4 months ago
At Viridian (NASDAQ: VRDN), we aim to advance new treatments for patients underserved by today's therapies. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data- driven decisions, strategic risk-taking, and efficient use of time and funds to best position our ideas for success. We value thoughtful ideas, open communication, and transparency, and are committed to a culture that allows employees to contribute at a high level, grow their careers, and balance their personal and professional ambitions.
Viridian Therapeutics is seeking a Manager of Regulatory Affairs to provide strategic and operational leadership to the development and commercialization of products within the Thyroid Eye Disease (TED) and Autoimmune portfolios. Reporting to the Sr. Director, Regulatory Affairs, the right experienced candidate will be a collaborative leader to work across the organization in this senior regulatory role to help us build the required capabilities to bring our products to patients.
This role is based in our Waltham, MA headquarters. Our office-based employees follow a hybrid in-office schedule. Remote work is allowed, and the frequency is at the discretion of management.
Responsibilities
(Including, but not limited to):
Support the preparation and implementation of regulatory strategy and regulatory submissions such as, BLAs/NDAs, MAAs, related supplements, responses to questions from government authorities regarding regulatory submissions, and annual reports.
Support program team and cross-functional colleagues to coordinate regulatory submissions in support of ongoing and future global clinical studies.
Write regulatory documents to support regulatory submissions.
Provide regulatory oversight and guidance to project teams on compliance matters, FDA and other competent authority requirements, clinical study design, timelines, logistics, and operations.
Work closely with clinical development and operations teams to facilitate clinical study progress, including protocol/CTA amendments and submissions.
Ensure compliance with laws and regulations governing clinical trial disclosure (eg EU CTIS and US clinicaltrials.gov).
Establish relevant processes and procedures to support the Regulatory A?airs functions.
Participate in regulatory intelligence gathering activities and maintain knowledge of US and EU regulatory requirements.
Requirements
Bachelor's degree in life sciences required; advanced degree preferred.
At least 5 years pharmaceutical industry regulatory experience
Experience in US and ex-US regulatory activities, registration and marketing requirements
Familiarity with eCTD formats.
Excellent communication/interpersonal skills;
Excellent organizational capabilities related to new drug development and clinical support activities.
Knowledge of FDA and international requirements for sections of IND, NDA and international ?lings as well as clinical trial disclosure requirements.
Excellent written and oral communication skills
Strong project management skills and drive for excellence
Strong commitment to ethical standards
Proficient with Microsoft Office Suite (i.e., Word, PowerPoint, Excel, Outlook, etc.)
Ability to travel up to 10%
The salary range for this position is commensurate with experience
Viridian offers a comprehensive benefits package including:
•Competitive pay and stock options for all employees
•Medical, dental, and vision coverage with 100% of premiums paid by Viridian for employees and their eligible dependents
•Fertility and mental health programs
•Short- and long-term disability coverage
•Life, Travel and AD&D
•401(k) Company Match with immediate company vest
•Employee Stock Purchase plan
•Generous vacation plan and paid company holiday shutdowns
•Various mental, financial, and proactive physical health programs covered by Viridian
Viridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.
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