Director, Regulatory Affairs - CMC

4 days ago

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Viridian Therapeutics, Inc.

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Description

• At Viridian Therapeutics, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. • Reporting to the Vice President, Regulatory Affairs CMC, the Director, Regulatory Affairs CMC will be responsible for leading CMC regulatory activities that support the company’s product development strategies. • This individual will ensure all applicable CMC regulatory requirements are considered and appropriately incorporated into clinical and commercial product development plans. • The incumbent will work collaboratively with senior leadership and key stakeholders to develop CMC regulatory objectives for one or more programs. • Lead the preparation and filing of regulatory CMC submissions, and manage the preparation for interactions with Health Authorities. • This role is fully remote for non-local candidates. • Travel to headquarters for meetings may be required at the discretion of management.

Requirements

• Bachelor’s degree in a science field such as Biology, Chemistry, or Pharmaceutical Sciences • Advanced degree preferred, but not required • Minimum of 10 years of increasing responsibility in Regulatory Affairs CMC within the biopharmaceutical industry • Demonstrated recent successful Regulatory Affairs track record in the development, submission, and registration of new drugs (biologics, innovative medicines, drug/device combination products, etc.) in the US, EU and/or international countries • Proven experience in the review, authoring, and/or managing of components of regulatory submissions such as of INDs, CTAs, NDAs/BLAs or MAAs, and their maintenance • Demonstrated experience interacting with the US FDA, EU, EMA, and other regulatory agencies • Candidates must have proven strategic development capabilities related to new drug development, commercial support, partner management, as well as product lifecycle management activities • Strong leadership abilities and the communication and interpersonal skills needed to influence decision-making • Strong oral and written communication, time management, and team-oriented leadership skills are essential • Ability to work independently, within a multi-disciplinary team, as well as with external partners and vendors • Proven mindset of proactive continuous improvement • Strong attention to detail • Ability to work in a fast paced-environment and to handle multiple tasks • Strong commitment to ethical standards

Benefits

• 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