Director/Sr. Director , Regulatory Operations

Director/Sr. Director , Regulatory Operations

The Role:

We are seeking a motivated individual to establish and lead a Regulatory Operations group within Moderna's broader Regulatory Affairs organization. The individual will be responsible for oversight and support of quality, timely regulatory submissions for all company products, including development of Regulatory Operations systems and practices; oversight of the publishing and submission of INDs, BLAs, MAAs, briefing packages, annual reports, safety reports, amendments, supplements, etc. The individual must have the ability to lead a functional team as an effective and engaged team member in a fast-paced environment. This role will report to the Head of Global Regulatory Affairs.

The Director/Sr. Director of Global Regulatory Operations will play a critical and leading role in leading publishing and operations efforts across the portfolio. The successful candidate will provide oversight to effectively support timely and quality submissions to ensure compliance to all global regulatory authorities and all aspects of electronic submissions and documentation that meet regulatory agency submission standards and technical requirements. He/She will coordinate the content finalization and review within cross-functional teams and subject matter experts, compile, prepare and review the various documents for content completeness and compliance with all the document standards.

Here's What You'll Do:

• Provides leadership and direction to the Regulatory Operations function, including the build and strategic scaling of an internal team and management of publishing vendors
• Responsible for logistics, preparation, quality check, and delivery of regulatory submissions in accordance with regulatory authority requirements and company standards. Acts as direct liaison with contributing departments and outsourced publishing vendor to facilitate effective management of submissions.
• Maintains current regulatory knowledge of submission requirements, content, format and publishing for submissions to global regulatory authorities, instructs the team of changes to process and implements appropriate regulatory strategies to mitigate risks
• Defines and implements standards and process efficiencies for submission management including drafting and adherence of SOPs and work instructions; ensures application of best practices standards are understood and followed by applicable departments/stakeholders and vendors
• Operates as subject matter expert in dossier types and/or processes with responsibility for training and mentoring regulatory staff and representatives from cross-functional teams
• Oversees compliant archiving of all regulatory documents and global regulatory correspondence, including developing archiving system and processes for regulating access to archives and overseeing maintenance of all correspondence logs.
• Maintains expertise in publishing best practices and manages relationships with vendors in the evaluation and implementation of regulatory submission processes, systems and software
• Act as a system administrator for Veeva RIM
  • Conduct user training
  • User assistance and system point of contact
• Perform other related duties as assigned.

Here's What You'll Bring to the Table:

• Bachelor's degree in a scientific discipline or systems technology
• 12+ years' experience in pharmaceutical or biotech industry in multiple phases of development (with both big and small company experience)
• 10+ years Regulatory Affairs experience in drug development and product registration activities
• Demonstrated expert knowledge of regulatory submission including IND, CTA, CTN, BLA, MAA submissions and technological advancement on global authority guidelines & current regulations in biologics and gene therapies
• Strong interpersonal skills and ability to work effectively and build relationships with cross-functional teams
• Knowledgeable in CTD/eCTD structure and requirements and US submissions, a solid understanding of international submission requirements for multiple-countries in all applicable global regions (EU, Asia Pacific, etc.)
• Strong knowledge of Microsoft Office suite, Adobe Acrobat, electronic document management systems, and viewing tools.
• A well-organized self-starter who shows strong initiative and drive, establishes priorities, able to anticipate departmental needs and develops templates, processes and procedures to ensure compliance with regulations
• Able to prepare interpretative analyses of key regulatory guidance documents related to submissions; interpret them, develop and implement submission strategies (from operations perspective)
• Must be able to adhere to strict project timelines and budgets, and to advise teams and management of impacts and changes in regulatory operations submission timelines.
• Must be able and willing to work in a high-visibility, fast- paced environment
• Must be flexible and able to work successfully within a cross-functional team

Here's What We'll Bring to the Table:

• Daily on-site catered lunches
• Company-provided iPhone
• Free parking, monthly subway pass or a subsidized commuter rail pass
• Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
• Flexible Spending Accounts for medical expenses and dependent care expenses
• 16 weeks of 100% paid parental leave for all new parents
• 16 weeks 100% paid family caregiver leave
• 20 weeks 100% paid medical leave
• Adoption assistance and discounts to local childcare centers, as well as access to care.com
• 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
• A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
• Voluntary legal assistance plan
• 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays

Why join Moderna Therapeutics

At Moderna, we believe messenger RNA, or mRNA, is the "software of life." Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of Science's list of top biopharma industry employers for the past four years. To learn more, visit www.modernatx.com .

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

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Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.