Location: New Haven, CT (Northeast preferred)

This will be a hybrid position, with both at-home, remote working and time in our New Haven, CT HQ. 

Position Summary:

The Manager, Regulatory will play a pivotal role in supporting overseeing regulatory activities related to Invivyd's initiatives. This role involves actively contributing to the development and execution of regulatory strategies, regulatory submissions, organization of regulatory communications and submissions, and collaboration with regional regulatory authorities. While providing valuable support to higher-level management, the Manager, Regulatory focuses on executing regulatory tasks, ensuring compliance, and facilitating cross-functional collaboration to achieve successful outcomes for Invivyd’s initiatives.

Responsibilities:

• Accountable for the execution of regulatory strategies including, but not limited to, compiling regulatory submissions such as IND, CTA, Amendments, and support major submissions such as (s)BLA, MAA, variations, etc. in compliance with applicable regulatory requirements
• Lead the compilation of Agency interaction documents such as Meeting Requests and Meeting Packages
• Lead Labeling Working Group for assigned submissions and responsible for USPI annotations and mockups
• In alignment with the global regulatory team, assist with management of regulatory activities related to assigned projects that encompass technical areas including clinical, non-clinical, and CMC
• Organizes and maintains regulatory files within the regulatory information management (RIM) system to ensure the Company’s compliance with regulatory requirements
• May guide one or more associates or contractors to handle regional requests and associated documentation

Requirements:

• BA/BS degree in biological/physical sciences required, advanced degrees preferred
• 5+ years relevant Regulatory Affairs experience in the biotechnology or pharmaceutical industry or a combination of education and experience
• Strong understanding of the drug development process, pharmaceutical regulatory requirements, healthcare environment and policy
• Strong written and oral communication and organizational skills, including ability to prioritize work tasks across multiple projects and timelines
• Ability to comprehend complex scientific information and regulatory guidelines, and formulate recommendations based on assessment
• Demonstrated ability to effectively work independently (with limited oversight) and/or collaboratively with pragmatism while navigating stressful situations and diverse stakeholders
• Experience effectively leading regulatory submissions and interactions in a fast-paced, matrixed environment
• Experience with document management and RIM systems, Veeva Vault (RIM Suite) experience preferred
• Proficient with MS Office tools to perform project management, tracking, writing and presentation tasks
• Strong problem-solving skills and attention to detail
• 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
• Ability to work onsite at least 1x/week in New Haven HQ

Pay Range

$120,000 - $160,000

The pay range represents the expected full-time base salary for this role at the time of posting. Actual base pay will be determined based on a variety of factors, including relevant experience, skills, and education. In addition to base pay, this role is eligible for both an annual short-term incentive (e.g., bonus or sales incentive) and an annual long-term incentive (e.g., equity), reflecting our commitment to rewarding strong performance and long-term impact. Learn more about our total rewards by visiting https://www.invivyd.com/careers/.

Location: New Haven, CT (Northeast preferred)

This will be a hybrid position, with both at-home, remote working and time in our New Haven, CT HQ. 

Position Summary:

The Sr. Director, Advertising and Promotion is a strategic role leading the review and approval and submission of advertising and promotional materials, related training, and other nonproduct commercial communications.  The Sr. Director will also be responsible for developing and managing labeling globally. In this role, you will be responsible for ensuring compliance with regulatory agencies’ requirements and Invivyd’s promotional, medical, and corporate communications objectives. Additional responsibilities will include monitoring regulatory compliance trends in industry and interpreting new and updated regulations and guidance documents for both labeling and promotion.

The Sr. Director, Advertising and Promotion will also coordinate training pertaining to advertising, promotion, and product launch activities.  The individual will work collaboratively with medical affairs, legal, compliance, and commercial teams in the development and implementation of advertising and promotional processes and materials for Invivyd’s product portfolio. 

The ideal candidate is someone who thrives in a fast-paced environment, is a strategic problem solver, and is proactive, flexible, detail-oriented, and hands-on.

Responsibilities:

• Represents Regulatory Affairs as a member of cross-functional commercial review committee, providing regulatory input into the review and approval of promotional and nonpromotional materials
• Maintain a deep and current awareness of evolving US and global regulations, Codes and guidelines, enforcement actions and policy issues affecting the pharmaceutical/biotech Industry as it pertains to labeling and promotion
• Effectively partner and collaborates with Medical Affairs, Legal, Compliance, Commercial, and other stakeholders as needed to ensure that promotional and non-promotional materials are reviewed in a timely fashion throughout the product life cycle
• Primary Liaison with OPDP and effectively manages relationships with FDA contacts
• Provide strategic regulatory advice for labeling taking into consideration marketing use post-approval
• Interpret and communicate regulatory perspective on promotional and non-promotional activities and risks to all stakeholders and management
• Coordinate regulatory training on regulatory issues pertaining to advertisement and promotion activities

Requirements:

• Doctorate, Master's, or Bachelor's degree in a relevant/scientific discipline (graduate degree preferred)
• Minimum of eight years working in the pharmaceutical or biotech industry with a minimum of 10-15 years in Regulatory Affairs
• Experience working with OPDP
• Thorough knowledge of US regulatory requirements pertaining to marketing authorization filings for new products or updates to existing products particularly related to advertising and promotion
• Knowledge of global drug/biologic regulations and standards particularly related to promotion including but not limited to EU and international Requirements is a plus
• Ability to work in a fast-paced environment where drive is critical to success
• Ability to assess areas of regulatory risk and effectively communicate and coordinate discussions to influence all business functions in order to reach resolution
• Strong writing, project management and communication skills
• Ability to travel as needed (2x a month) to our New Haven, CT office

Pay Range

$220,000 - $293,000

The pay range represents the expected full-time base salary for this role at the time of posting. Actual base pay will be determined based on a variety of factors, including relevant experience, skills, and education. In addition to base pay, this role is eligible for both an annual short-term incentive (e.g., bonus or sales incentive) and an annual long-term incentive (e.g., equity), reflecting our commitment to rewarding strong performance and long-term impact. Learn more about our total rewards by visiting https://www.invivyd.com/careers/.