Senior Director, Regulatory Affairs
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The Senior Director of Regulatory Affairs will lead the overall regulatory strategy for Adverum’s development programs, aligning with program and corporate goals. This individual will serve as the internal and external regulatory lead, overseeing program implementation and assisting in developing procedures to ensure regulatory compliance. The Executive Director will be accountable for developing, implementing, and advising on global regulatory strategies through all phases of clinical development success of Adverum’s programs. This role involves managing the regulatory aspects of Adverum’s development products. The Executive Director will have significant influence and/or oversight within the department and core teams and will act as an advisor and liaison to senior management to plan, evaluate, and recommend regulatory strategies for their products. This individual will also engage with external regulatory agencies and business partners, as necessary, regarding development, regulatory, and registration strategies. Additionally, this position may involve line management, mentoring, people development, and performance management, as well as supporting and leading the development and implementation of departmental policies and procedures.
What you'll do:
- Oversee the Regulatory Affairs (Nonclinical, Clinical, or CMC) Strategy for Regulatory Affairs department.
- Serve as regulatory subject matter expert and an influential leader within the R&D organization, contributing to drug development efforts at Adverum for its development programs.
- Provide high-level strategic and operational regulatory guidance and mentorship on projects. This includes but not limited to general regulatory strategies, understanding regulatory requirements for clinical studies in both domestic and international markets, creating regulatory strategic development plans, conducting risk assessments, managing critical issues, and advising on interactions with health authorities. Ensure cross-functional alignment on regulatory plans and strategies.
- Keep line management and key stakeholders informed of developments that may impact regulatory success.
- Anticipate risks and lead internal discussions to identify innovative solutions. This includes assessing and communicating the probabilities of technical and regulatory success.
- Utilize extensive knowledge of U.S., EU, and ICH regulatory requirements and apply this knowledge strategically and operationally to development projects and regulatory issues to support corporate goals. Demonstrated experience in managing complex worldwide products/projects is essential.
- Develop and implement innovative regulatory strategies aimed at submitting investigational and marketing applications (INDs/CTAs and BLAs/MAAs) in compliance with global regulatory agency requirements.
- Lead regulatory activities for assigned projects and territories in alignment with ICH requirements, regional regulations, and company policies and procedures.
- Possess strong scientific and technical expertise, capable of developing robust global regulatory plans covering all phases of drug development.
- Guide and direct the effective execution of developed regulatory strategies and tactics. Ensure the timely production and submission of regulatory documentation for assigned programs.
- Work effectively within a matrixed and team-oriented environment, employing excellent communication, interpersonal, and relationship management skills to interact successfully with Clinical Development, Clinical Operations, Clinical Science, Data Management, Biostatistics, Research Scientists, and other teams within the organization.
- Build a strong relationship with regulatory authorities and act as primary liaison in matters of development and registration, including conducting meetings with regulatory agencies.
- Support the creation and development of content for regulatory submissions. Review sections of IND/CTA and other global submission documents to ensure compliance with local regulatory requirements for clinical trials and their amendments.
- Review inputs to the regulatory submissions and provide regulatory input into target product profile.
- Responsible for regulatory intelligence in relevant disease area, identifying and communicating implications of upcoming trends that may impact the business.
About you:
- BS Degree is required/preferred; an advanced degree (Masters, PharmD, PhD) is a valuable asset; an equivalent combination of education and experience
- A minimum of 15 years of Regulatory Affairs experience in a regulated industry
- Extensive regulatory experience, including IND/CTA, BLA/MAA, life-cycle management, interactions with Health Authorities, and leading and managing teams.
- Proven ability to develop and implement complex regulatory strategies with a track record of significant regulatory accomplishments. Experience in collaborating with external business partners and Regulatory Agencies is important.
- Demonstrated ability to work successfully within a cross-functional team environment and influence outcomes with a high level of professionalism.
- Experience in specialty pharmaceuticals or rare & orphan disease experience is advantageous.
- Strong skills in conflict resolution and negotiation, fostering open communication, listening, and facilitating effectively.
- Solid knowledge of regulatory and business strategies to ensure alignment with overall corporate goals.
- Must be willing to work in a smaller organization and undertake additional duties as assigned.
- Demonstrate excellent communication and influencing skills at all levels of the organization, both internally and externally.
- Strong organizational, communication, negotiation, and interpersonal skills are essential.
- Ability to effectively negotiate and influence upper management, team members, regulatory agencies, and industry stakeholders to meet the company’s regulatory and business needs is required.
- Ensure compliance with US, EU, and international regulations.
- Work on special projects as requested.
- Willingness to travel for business up to 10-20% of the time.
The salary range for this position is $236,818 USD to $261,801 USD annually, with the opportunity to earn an annual bonus. This salary range is an estimate, and the actual salary may vary based on a candidate’s qualifications, including education, length of experience, location, and market data. Employees in this position are eligible to participate in the applicable Company equity incentive award plan. The amount of incentive varies and is subject to the terms and conditions of the plan. Employees in this position are eligible to participate in the Company’s standard employee benefit programs, which currently include the following: medical, dental, vision, 401k, STD/LTD, life and accident insurance, and either paid time off or flexible paid time off.
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.
At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self. We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation