Vice President, Regulatory Affairs CMC

Description

At Viridian Therapeutics, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets.

Reporting to the Senior Vice President, Regulatory Affairs, the Vice President, Regulatory Affairs CMC is a key strategic role ensuring regulatory CMC strategies support global approvals and maintenance of global licenses. This individual will be recognized as a global thought leader for Regulatory Affairs and be accountable for leading the interpretation and implementation of CMC regulatory guidelines, regulations and current environment to assure approvability in high priority regions.

This role may be fully remote or 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. Travel to headquarters for meetings may be required at the discretion of management.

Responsibilities (including, but not limited to):

• Lead the Regulatory CMC function to support the CMC portfolio goals with proven track record of successfully building and leading teams
• Lead global CMC regulatory strategies for projects in development and marketed products, including risk mitigation strategies to ensure approvals and maintenance of product licenses
• Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions including Technical Operations, Quality, and Regulatory Affairs
• Exercise expertise in the interpretation and implementation of ICH guidelines with a goal of an approved/ harmonized regulatory control strategy
• Ensure regulatory conformance & consistency for assigned products globally in compliance with regulatory requirements and internal procedures
• Closely interact with multiple functions to create high quality regulatory submissions that support product development strategy
• Has a proven track record of working with regulators to find solutions and drive positive impact and benefits for patients
• Facilitate the development of and reviews and comments on all technically complex CMC documentation for submission to regulatory authorities including process development, process validation, analytical method development, and analytical method validation supporting establishment of specifications and in-process, release and stability data and information appropriate to phase of development
• Develop meaningful and collaborative relationships with local & global internal/ external partners
• Mentor individuals with varying backgrounds, enabling them represent the organization internally and externally
• Actively engage and influence organization to think proactively and utilize science and risk-based approach to product development and life-cycle management activities

Requirements

• Requires 15+ years of professional experience in global CMC regulatory affairs and CMC technical areas
• A scientific degree: BA/BS, MA/MS, PhD or PharmD
• Regulatory CMC experience in biologic drug development and registration activities
• Experience managing complex regulatory projects that span multiple years, systems and regulatory standards
• Thorough knowledge of the drug development process
• Must possess and demonstrate an excellent understanding of FDA and international regulatory requirements and guidelines
• Detailed familiarity with the content and structure of regulatory submissions, including the eCTD
• Excellent communication skills, with the ability to communicate concisely and clearly across all levels of the organization
• Proven mindset of proactive continuous improvement
• Strong attention to detail
• Ability to work in a fast paced-environment and to handle multiple tasks
• Strong strategic thinking and problem-solving skills, with the ability to make informed decisions using risk-based approaches
• Strong commitment to ethical standards
• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
• Ability to travel up to 15%
• 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.