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    Vice President, Head of Regulatory Affairs - Emeryville, United States - Metagenomi

    Metagenomi
    Metagenomi Emeryville, United States

    1 week ago

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    Description

    Metagenomi is a gene editing company committed to developing potentially curative therapeutics by leveraging a proprietary toolbox of next-generation gene editing systems to accurately edit DNA where current technologies cannot. Our metagenomics-powered discovery platform and analytical expertise reveal novel cellular machinery sourced from otherwise unknown organisms. We adapt and forge these naturally evolved systems into powerful gene editing systems that are ultra-small, extremely efficient, highly specific and have a decreased risk of immune response. These systems fuel our pipeline of novel medicines and can be leveraged by partners. Our goal is to revolutionize gene editing for the benefit of patients around the world.

    Whether it's the biological diversity of our gene editing systems or the people that help discover them, Metagenomi celebrates the diversity of life. This is achieved through a compassionate culture that acknowledges the dimensions of our diversity. We know that when people feel a sense of inclusion and belonging in the workplace, they have a safe space to bring creativity and innovation to everything they do. We are intentional about building and maintaining a culture where people are valued and respected, there is equity in opportunities, and our respective opinions and differences matter.

    We are hiring a Vice President of Regulatory Affairs to build our Regulatory function and define our global regulatory strategies from pre-IND to regulatory approvals across our in vivo and ex vivo gene editing product portfolio.

    Reporting to the Chief Medical Officer, this role will serve as the primary point of contact representing the company to global regulatory agencies, manage content and operational aspects for all regulatory submissions, and oversee clinical (GCP) quality affairs. This person will be the company's Regulatory Head for strategy, execution, regulatory operations, and partnership with other functions. As we mature our pipeline, this person will advance therapies into the clinic and market in a high-impact role while building the function. The position will be based in Emeryville, California.

    How you'll contribute:

    • Building and leading the Regulatory Affairs function in the development and implementation of global regulatory strategies and processes to gain global product approvals
    • Serving as the primary point of contact for global regulatory authorities, regulatory inspections, and overseeing the company's GLP/GCP vendor/site audit plans
    • Educating the company on regulatory issues, recent trends in approvals, and initiating regulatory intelligence activities as appropriate
    • Managing the strategy and operational aspects of all regulatory submissions (INDs, NDAs, MAAs, etc), including the oversight of vendor activities and budgets
    • Overseeing the review and approval for product packaging and labeling, and when appropriate, participating in the approval of advertising and promotional materials and activities
    • Partnering with the executive leadership team on presentations to the Board of Directors, investors, potential corporate collaborators, and all other external constituents
    • Contributing to the development and maintenance of a positive team-focused company culture
    Must haves:
    • Minimum of BA/BS in a scientific discipline with at least 12 years of pharmaceutical and/or biotechnology industry experience - regulatory affairs certification (RAC) and/or graduate work in the life sciences/engineering preferred
    • Strong leadership skills to translate corporate objectives into effective regulatory action plans
    • Experience leading global regulatory organizations through critical product milestones, preferably with some experience in rare disease development involving novel regulatory strategies and novel treatment modalities
    • Experience with all phases of product development, including complex international early-stage development programs involving gene editing, gene therapy, or cell therapy products
    • Extensive hands-on experience in the development of key regulatory submissions, including NDAs, BLAs, MAAs, and INDs, as well as interacting with regulatory authorities and supporting site/sponsor regulatory inspections
    • Experience in developing and tracking departmental budgets
    • Outstanding leadership abilities with a track record of recruiting, developing, retaining, and motivating high-performing teams
    • Thorough understanding of GCP and ICH Guidelines governing the conduct of clinical trials, applicable sections of the Code of Federal Regulations, and GMP requirements
    • Solution-oriented team player with executive presence and demeanor, excellent written and verbal communication skills, and outstanding analytical abilities
    • Ability to adapt quickly to changing environments and priorities
    • Positive attitude and high personal and ethical standards in achieving corporate goals
    Metagenomi Company Values:

    Driven by innovation

    Dedicated to scientific rigor

    Championed by each other

    California Pay Transparency Disclosure:

    This position is classified as exempt under the Federal Labor Standards Act. This position's anticipated base salary range will be $305,000 - $365,000. Metagenomi has the right to modify this range at any time. Depending on the position offered, you will also be eligible to receive equity, bonuses, and a full range of benefits. Please note that individual total compensation for this position will be determined at the Company's sole discretion and may vary based on location, skill level, years and depth of relevant experience, and education.

    What makes Metagenomi a unique place to work?
    • We are passionate about developing technologies derived from microbial-rich ecosystems that have the power to enable therapeutic development and the potential to cure devastating diseases.
    • We have cultivated an amazing culture that values teamwork, curiosity, scientific rigor, and fun. We have a strong commitment to work/life balance, host a weekly employee happy hour and events, provide catered lunches and endless snacks, and more
    • We offer competitive compensation, including a market-benchmarked salary, annual target bonus potential, equity, comprehensive benefits plan, 401(k) with company matching, retirement safe harbor plan, and other perks.
    At Metagenomi, we know that our people drive our success. We are an equal opportunity employer and believe in and value diversity and inclusion. Metagenomi provides an open, collegial, and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers. Metagenomi does not discriminate on the basis of race, color, religion, sexual orientation, gender, age, physical or mental disability, or any other status protected under federal, state, or local law.

    Applicants/Employees have rights under various State and Federal Employment Laws, including without limitation:
    • Family & Medical Leave Act
    • Equal Employment Opportunity Commission
    • Employee Polygraph Protection Act
    • California Family Rights Act
    • California Fair Employment and Housing Act
    Notice to agencies: Our in-house Talent Acquisition Team manages all employment opportunities at Metagenomi. Agencies and independent recruiters must be approved as a vendor by Metagenomi's Talent Acquisition team. To protect the interests of all parties, Metagenomi will not accept unsolicited resumes, profiles, or biographies. Any unsolicited resumes sent to Metagenomi will be considered referrals and the property of Metagenomi.
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