Director/Senior Regulatory Affairs CMC

Redwood City, CA, United States

The Director/Sr Regulatory Affairs will lead the overall CMC Regulatory strategy for Adverum's gene therapy program/s. This individual will be the key interface between the Regulatory and CMC functions, partner with Process Development, Manufacturing, Supply Chain, and Quality; and assist in ensuring regulatory compliance. The Director/Sr will be responsible for developing, executing, and advising on global Regulatory CMC strategies through all phases of Adverum's development program/s. As appropriate, this individual may interface with business partners regarding development, regulatory, and registration strategies.

What you'll do:

Manage the Regulatory Affairs (CMC) Strategy for Regulatory Affairs

Strengthen internal gene therapy CMC capability and serve as regulatory subject matter expert and influential leader within the R&D organization to contribute to drug development at Adverum for its development programs

Proactively partners with Technical Operations, Manufacturing, and Quality counterparts on processes and program prioritization; Ensures cross-functional alignment on regulatory plans and strategies

Proactively partners and aligns with the SVP/Head of Regulatory on the development of the regulatory CMC strategy; ensures line management and key stakeholders are apprised of developments that may impact regulatory success in a timely manner

Function as the regulatory CMC Lead, working with other Regulatory colleagues to drive regulatory strategies

Provide high-level strategic and operational regulatory direction and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for domestic and international markets, regulatory strategic development plans and risk assessments, critical issue management, and advice on Health Authority interactions

Anticipate risks and lead internal discussions to find innovative solutions for the identified risks, including assessment and communication of probabilities of technical and regulatory success

Build the scope and design of experiments as well as troubleshoot the generation of robust GMP processes and analytics for Adverum's gene therapy products

Possess strong scientific and technical expertise, including the ability to develop robust and compliant global regulatory strategies covering all phases of drug development

Lead and provide direction for the effective execution of the developed regulatory strategies, tactics, and implementation of all regulatory aspects of the assigned program and responsible for the timely production and submission of regulatory documentation

Must be able to work effectively in a strongly matrixed team-oriented structure using excellent communication, interpersonal, and relationship management skills to interact with the Technical Operations and Quality staff successfully, and other teams within the organization, as needed

Must have a proven track record of managing critical projects as a part of an interdisciplinary team

Responsible for regulatory intelligence for trends that may impact the business;

Maintain regulatory expertise and serve as an internal consultant on relevant global CMC regulations and guidelines, current regulatory environment, and regulatory precedence

Must be willing to work in a smaller organization and support other duties and special projects as assigned

Demonstrate excellent communication and influencing skills internally and externally at all levels of the organization

Possess curiosity and passion for science and new manufacturing technologies

Ability to effectively work in a multi-disciplinary team

May be responsible for creating and reviewing SOPs

Actively trains/mentors junior staff; provides broader guidance on regulatory interpretation to staff inside and outside Regulatory Affairs

May supervise Regulatory Affairs team members

Having an eye for detail is required

About you: BS, MS, Masters, PharmD, PhD in science preferred or equivalent relevant experience

A breadth of regulatory experience with at least 12-15 years of Regulatory Affairs experience in a regulated industry; the regulatory experience should be broad (across the life cycle of biotech products and across main regions such as US, EU, Japan, and Canada)

Extensive regulatory experience including IND/CTA, BLA/MAA, life-cycle management, interactions with Health Authorities, leading and managing teams, developing and implementing complex regulatory strategies with a proven track record of significant regulatory accomplishments

Proven ability to work successfully and influence within a cross-functional team/partnership environment with a high level of professionalism

Management experience preferred

Skilled in conflict resolution/negotiation. Fosters open communication. Listens and facilitates discussion

$200,000 - $270,000 a year

The salary range for this position is $200,000 USD to $270,000 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, l ength 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.