Director/Sr. Director Regulatory Affairs (CMC)

Location
Redwood City, CA
Posted
Jul 29, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Contract
As the Director/Sr. Director, Regulatory Affairs Chemistry, Manufacturing and Controls (RACMC), you’ll have the opportunity to oversee and direct all CMC regulatory strategies. You’ll provide strategic input, perform risk assessments, and oversee preparation of CMC regulatory submissions. You’ll also collaborate with functional areas to provide regulatory guidance on quality related issues, provide the best possible CMC regulatory strategies that integrate with plans for other disciplines and company objectives, and to ensure timely and accurate preparation and review of regulatory submissions and related CMC documents. Finally, you will be able to supervise or manage others within the RACMC skill group.

What you'll do:
  • Function as RACMC lead for assigned products and regions
  • Provide strategic RACMC interpretation and guidance to project teams from early development through post-approval
  • Develop and execute the regulatory strategy (CMC aspects) to support the lifecycle of assets; determine from a strategic and scientific perspective the content of relevant CMC sections (technical and/or procedural) of project/product specific documents submitted to regulatory agencies (e.g. NDA, BLA, MAA, INDs, IMPDs, etc.) and ensure that these documents meet high scientific standards and regulatory requirements
  • Lead project/product-related discussions and provide strategic, scientific and regulatory input, for RACMC and/or procedural aspects
  • Direct creation of and update to quality sections of regulatory filings; compile/write/review high quality project/product specific CMC documents to be submitted to regulatory agencies and ensure that those documents meet regulatory requirements; review quality submission documents to ensure consistency with related filings, industry standards and regulatory requirements
  • Review CMC protocols/test methods; review and approve clinical manufacturing plans and labeling, and authorize drug shipment to clinical sites
  • Interact with manufacturing and quality groups, regulatory agencies, contract and partner organizations, regarding RACMC issues; assess impact of manufacturing changes pertaining to approved commercial products
  • Interface with international affiliates on regional regulatory strategy and implementation plans
  • Conduct business development efforts, as needed
  • Effectively communicate comments/recommendations and proactively engages program teams to establish solution to issues
  • Provide coaching, mentoring and knowledge sharing within the RACMC skill group
  • Review and approve timesheets and expense reports and guiding the performance of assigned staff
  • Excellent listening, verbal and written communication and presentation skills, as this position will interface with all levels within the organization, regulators, partners and key opinion leaders.
  • Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.


About you:
  • Bachelor’s degree, or international equivalent, in a science or health related field; PhD preferred, along with 12+ years of experience in the CRO, pharmaceutical, biotechnology or device/diagnostics industry (an advanced degree will be considered in lieu of a portion of industry experience); 8-9 years of RACMC experience in a CRO, pharmaceutical, device/diagnostics or biotechnology company; 6-7 years supervisory/management experience
  • Advanced knowledge of regulatory requirements, including ICH and FDA
  • Diverse experience including drugs, biologics, devices and international filings preferred
  • Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously
  • Results driven and team oriented, with the ability to influence outcomes as necessary
  • Able to develop and implement creative approaches to ensure regulatory success
  • Able to innovate, analyze, and solve problems with minimal supervision
  • Exceptionally keen attention to detail
  • Demonstrated ability to manage a staff of up to 5 employees to achieve company and client goals
  • Business travel up to 10-15% travel

About Us
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