Director/Senior Regulatory Affairs CMC
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