Director, CMC Regulatory Affairs
San Francisco, California, United States of America
Full Time
3 weeks ago
$195,500 - $272,500 USD
Key skills
Leadership
About this role
Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN® dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies.
Vir Biotechnology has exclusive rights to the universal PRO-XTEN® masking platform for oncology and infectious disease. PRO-XTEN® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.
We believe the success of our colleagues drives the success of our mission. We are committed to creating a company where everyone feels supported and encouraged to give their best.
THE OPPORTUNITY
Vir Biotechnology is seeking an a highly motivated, self-driven and enthusiastic Director of Regulatory CMC accountable for ensuring all assigned products have a successful regulatory CMC strategy for clinical development and commercialization. You should bring both a track record of successful regulatory submissions that demonstrates core capability in technical (CMC) development, as well as a passion to challenge conventional paradigms and influence global Health Authorities. We are looking for someone with experience or willingness to expand to cover multiple modalities. The ideal candidate will contribute to a culture of high performance, empowerment, continuous learning and diversity and inclusion. This position will work closely with the Technical Operations (CMC) functional groups and Regulatory Affairs department to plan and lead high quality regulatory submissions to health authorities.
This role is located in our San Francisco headquarters with an expectation of 3 days per week in office.
WHAT YOU'LL DO
- As a member of the CMC project teams, provide strategic CMC regulatory leadership to develop and execute sound regulatory strategies that meet global regulatory requirements and enable Vir business objectives
- Provide CMC regulatory expertise to enable global development and registration for INDs, CTAs, BLAs and MAAs
- Identify and communicate regulatory risks and facilitate the development and execution of risk mitigation strategies in concert with Technical Operation functions
- Plan strategy for and lead HA interactions for CMC specific issues
- Manage CMC regulatory changes throughout the product life cycle, including support for relevant quality systems related to change control, discrepancy management, as well as Health Authority inspection support (as applicable)
- Ensure overall dossier compliance with regulatory requirements
- Ensure compliance with internal SOP's and policies
- Contribute to regulatory excellence by identifying opportunities and supporting continuous improvement
WHO YOU ARE AND WHAT YOU BRING
- B.S., M.S., Ph.D. or other relevant advanced degree or certificate
- 10+ years experience in pharmaceutical product development including strong global Regulatory CMC leadership
- Regulatory CMC experience leading both development projects (IND/CTA) and initial registration (BLA/MAA)
- Experience with CMC regulatory considerations for late stage and/or commercial large molecules (biologics) is required experience with combination product or oligonucleotide experience is a plus
- Preference will be given to candidates with recent experience with initial BLA and/or NDA (CMC sections). Management of US post-market, biologic product CMC changes is a plus
- Experience with Health Authority interactions is desirable
- Thorough understanding of major FDA, EMA, ICH, EudraLex CMC guidelines
- Global clinical filing experience (US, EU, UK, CA,). Working knowledge of other global clinical territories procedures a plus
- Ability to effectively present to Senior Management
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WHO WE ARE AND WHAT WE OFFER
The expected salary range for this position is $195,500 to $272,500. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
Vir Biotechnology's compensation and benefits are aligned with the current market and commensurate with the person’s experience and qualifications. All full-time employees receive a package that includes compensation, bonus and equity as well as many other Vir Biotechnology benefits and perks such as health and welfare benefit plans, non-accrual paid time off, company shut down for holidays, commuter benefits, 401K match and lunch each day in the office.
Applicants must currently be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
All employment decisions at Vir Biotechnology are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications. Employment decisions are made without regard to any legally protected characteristics.
This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs. Vir Biotechnology also strongly commits to providing employees with a work environment free of unlawful conduct or harassment.
Vir Biotechnology Human Resources leads recruitment and employment for Vir Biotechnology. Unsolicited resumes sent to the company from recruiters do not constitute any type of relationship between the recruiter and Vir Biotechnology and do not obligate us to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.
For hires based in the United States, Vir Biotechnology, participates in E-Verify.