Full-Time

Director – Global Regulatory Science CMC

Oncology

Posted on 9/10/2024

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines for health

Senior, Expert

Norwood, MA, USA

Position based at the Norwood, MA site.

Category
Risk & Compliance
Legal & Compliance
Requirements
  • Bachelor’s degree in a scientific/engineering discipline
  • 12+ years of experience in the pharmaceutical/biotech industry
  • 8 + years of experience in Regulatory CMC
  • Strong knowledge of current Global CMC regulations, including with CTD format and content of CMC regulatory submissions
  • Strong knowledge of and broad experience with regulatory procedures and legislation related to CMC aspects for drug development, product registration, line extension and license maintenance
  • Ability to effectively collaborate in a dynamic, cross-functional matrix environment to drive meeting each program’s critical regulatory milestones
  • Prior management experience required
  • Excellent interpersonal skills for internal and external negotiation and influence
  • Exceptional written and oral communication skills
  • Bachelors Degree with 15 years of experience in the pharmaceutical/biotech industry
  • MS/PhD degree in Molecular Biology, Pharmaceutics, Chemistry, or closely related field is desirable
  • 10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus
  • 8+ years of experience in Biologics focused Regulatory CMC
Responsibilities
  • Develop/implement effective CMC regulatory strategies for submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks
  • Provide guidance for regulatory CMC aspects of product development projects
  • Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines
  • Lead Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions
  • Develop regulatory processes and procedures to support CMC components of regulatory submissions
  • Support the creation and maintenance of CMC submission templates
  • Provide CMC regulatory guidance to manufacturing and quality teams; evaluate CMC change controls
  • Perform assessment of manufacturing change controls
  • Provide interpretation of regulatory guidance documents, regulations, and directives – advise Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs
  • Lead oversight of multiple programs in various therapeutic areas (vaccines, oncology and/or rare diseases)

Moderna focuses on developing medicines using messenger RNA (mRNA), which is a crucial component in how cells produce proteins necessary for various biological functions. Their approach involves creating a new class of medicines that utilize mRNA to instruct cells to produce specific proteins, potentially leading to significant advancements in treatment options for patients. Unlike traditional pharmaceuticals, which often rely on chemical compounds, Moderna's mRNA-based therapies aim to enhance the discovery, development, and manufacturing processes of medicines. The company's goal is to harness the power of mRNA to improve patient outcomes and transform the landscape of medical treatments.

Company Size

5,001-10,000

Company Stage

IPO

Total Funding

$6.5B

Headquarters

Cambridge, Massachusetts

Founded

2010

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Simplify's Take

What believers are saying

  • Moderna plans to launch a cancer vaccine with Merck by 2027.
  • The company secured a $590 million contract for bird flu vaccine development.
  • Moderna's mRNA COVID-19 vaccine supply agreement with the EU spans four years.

What critics are saying

  • Moderna faces a high-profile patent lawsuit with Pfizer and BioNTech.
  • The company reported significant net losses in 2024, impacting financial stability.
  • Regulatory scrutiny may delay product approvals, affecting future growth.

What makes Moderna unique

  • Moderna is pioneering mRNA as a new class of medicines.
  • The company focuses on mRNA technology for personalized medicine and vaccines.
  • Moderna's mRNA platform enables rapid development of therapeutics and vaccines.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

Sabbatical Leave

Hybrid Work Options

401(k) Company Match

Parental Leave

Family Planning Benefits

Fertility Treatment Support

Adoption Assistance

Wellness Program

Mental Health Support

Phone/Internet Stipend

Home Office Stipend

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

0%

2 year growth

4%
Assure Test
Mar 7th, 2025
Pfizer & BioNTech vs. Moderna: COVID-19 Vaccine Patent Lawsuit

The high-profile lawsuit between Pfizer, BioNTech, and Moderna over mRNA COVID-19 vaccine patents remains one of the most closely watched cases in 2025.

Bloomberg
Mar 5th, 2025
Moderna Eyes 2027 Launch for Cancer Vaccine Developed With Merck

Moderna Inc. expects to launch a personalized cancer vaccine that it's developing with Merck & Co. by 2027, one of its top executives said.

The Wall Street Journal
Feb 27th, 2025
Moderna Shares Fall After Reports of HHS Review of Bird Flu Vaccine Contract

Moderna was awarded the contract from the U.S. Department of Health and Human Services in January during the Biden administration to accelerate development of its mRNA-based vaccine, and as part of an effort to address growing concerns of a bird flu pandemic in humans.

Financial Modeling Prep
Feb 14th, 2025
Moderna, Inc. (NASDAQ:MRNA) Faces Challenges and Opportunities in Biotech Sector

Moderna is developing new products, including a next-generation COVID vaccine, with a revenue forecast between $1.5 billion and $2.5 billion for 2025.

PharmiWeb
Feb 14th, 2025
Moderna Reports Fourth Quarter And Fiscal Year 2024 Financial Results And Provides Business Updates

Reports fourth quarter revenues of $1.0 billion, GAAP net loss of $(1.1) billion and GAAP EPS of $(2.91); loss includes approximately $0.2 billion of non-cash charges related to manufacturing resizingReports full-year revenues of $3.2 billion, GAAP net loss of $(3.6) billion and GAAP diluted EPS of $(9.28)Expects 2025 revenue range of $1.5 to 2.5 billion andending cash balance of approximately $6 billionSubmitted three investigational mRNA products for regulatory approval, including Moderna's next-generation COVID vaccine, RSV vaccine for high-risk adults aged 18 to 59, and flu/COVID combination vaccineCAMBRIDGE, MA / ACCESS Newswire / February 14, 2025 / Moderna, Inc. (NASDAQ:MRNA) today reported financial results and provided business updates for the fourth quarter and fiscal year 2024."We have made progress in 2024 across our late-stage pipeline and cost reduction efforts. Our team successfully filed three Biologics License Applications in the final months of the year and reduced our costs by 27 percent compared to 2023," said Stéphane Bancel, Chief Executive Officer of Moderna. "In 2025, we remain focused on driving sales, delivering up to 10 product approvals through 2027, and expanding cost efficiencies across our business. By the end of 2025, we aim to remove nearly $1 billion in costs. With strong momentum in our late-stage pipeline, we anticipate multiple approvals starting this year, along with key Phase 3 readouts that will support our long-term growth."Recent progress includes:Commercial UpdatesModerna is entering 2025 with two approved products, Spikevax® and mRESVIA®.COVID-19: The Company reported $923 million in Spikevax® sales in the fourth quarter of 2024, which includes $244 million of U.S

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