- The Manager of Regulatory Operations is responsible for supporting key functions within the Regulatory Operations team and across the organization. This includes overseeing submission projects, including the planning, tracking, assembly, submission, and archiving of regulatory documents in collaboration with other team members and vendors.
- Ensuring electronic assembly of all submissions are planned, coordinated, and delivered on time, and adhere to regulatory standards in collaboration with external vendors.
- Maintain Veeva Vault RIM system and ensure that content plans and regulatory records are up to date.
- Ensure that is updated and accurate accordingly.
- Ensure that all US/ex-US submissions and correspondence files are up to date.
- Maintain templates and style guides for regulatory submissions.
- Working closely with other members of the Regulatory team and providing support to their projects as needed.
- Establish a collaborative partnership with business units to understand their requirements and strategic vision.
- Additional duties and responsibilities as required.
- A BS/BA is required.
- 5+ years of experience managing Regulatory Operations in a Biotech or pharmaceutical company.
- Proficient on global Regulatory Submission requirements
- Knowledge in global requirements for submission formats (eCTD for IND, BLAs, and routine submissions)
- Experience with Veeva Vault systems
- Proficiency in
- Proficiency in technologies such as Egnyte, eCTD publishing tools, Smartsheets and Microsoft Office Suite
- Ability to manage multiple projects simultaneously, manage conflicting priorities, and be flexible when priorities change.
- Travel requirement of [10%] domestic and global.
- Brings attention to detail coupled with creative thinking to work through obstacles.
- Experience working with all levels of management and consulting with key business stakeholders.
- An 'always learning' approach - willing to test out new ways of working and thinking.
- An ability to influence for greater outcomes.
- Independent thinker with a strategic mindset, sound business judgment and exceptional Regulatory Operations skills.
- Demonstrated ability to lead others through matrix to deliver outstanding results.
- Ability to strategically translate customer needs into executable action plans.
- Excellent interpersonal, communication, and presentation skills with the ability to interface seamlessly with other parts of organization.
- Active listener, low-ego team player mentality, and a willingness to always go the extra mile.
- The salary range for this position is commensurate with experience.
Manager, Regulatory Operations - Waltham, United States - Viridian Therapeutics
Description
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, thoughtful 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 has an exciting new opportunity to join our growing Regulatory team as a Manager, Regulatory Operations. Reporting to the Director, Regulatory Operations, the Manager, Regulatory Operations will be responsible for the execution of Regulatory Submissions operational activities in support of pipeline programs. The ideal candidate will enjoy troubleshooting complex problems as they arise and driving sustainable solutions. You will also work to identify key value add enhancements for Regulatory Operations and drive implementation forward.
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):
•C ompetitive 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.