Regulatory Affairs Director - Microbiology and Compliance

About the role

The Regulatory Affairs Director – Microbiology and Compliance reports to the Senior/Executive Director or Vice President of Regulatory Affairs and is responsible for preparing CMC regulatory strategies that enable first pass approvals. This role develops and manages content strategy for regulatory submissions, with a focus on sterile manufacturing, including new marketing applications and supplements. The position builds and maintains relationships within Regulatory Affairs, CMC, product supply and device groups, and manages products and change controls in compliance with regulations and company policies.

Responsibilities

• Prepare CMC regulatory strategies to support first pass approvals and successful NDA/BLA submissions.
• Develop and manage content strategy for regulatory submissions, focusing on sterile manufacturing and new marketing applications.
• Align CMC regulatory plans with cross-functional development and manufacturing teams.
• Direct negotiations and manage strategic FDA interactions related to CMC and GMP compliance.
• Evaluate proposed manufacturing and quality changes for impact on ongoing and existing filings and provide strategic regulatory guidance.
• Facilitate the development, review, and comment on technically complex CMC documentation for submission to regulatory authorities, including drug substance, drug product, and drug/device combinations.
• Train global functions within Regulatory Affairs and CMC, product supply, and device groups in U.S.-specific CMC and compliance requirements.
• Monitor changes in the regulatory CMC landscape and analyze the impact of evolving regulations on assigned projects.
• Manage, train, and mentor regulatory affairs personnel.

Essential Functions

• Strong background in aseptic processing, fill-finish operations, sterilization processes, cleanroom operations, environmental monitoring, quality systems, and equipment and process validation.
• Experience supporting FDA cGMP inspections.
• Ability to define regulatory pathways and milestones for submissions to support development activities leading to successful NDA/BLA approvals.
• Excellent interpersonal, oral, and written communication skills, including presentation skills.
• Demonstrated ability to work in a dynamic environment with flexibility and in cross-functional teams.
• Ability to prioritize competing work streams simultaneously.
• Highest ethical standards, integrity, credibility, and character.

Qualifications

• Science degree required; advanced degree strongly preferred; doctorate preferred.
• Industry experience of 12 years, with at least 7 years in CMC responsibilities.
• Experience preparing and executing CMC regulatory development strategies in biologics, including leading successful NDA/BLA submissions.
• CMC microbial control experience related to sterile manufacturing.

Physical Requirements

• 0-10% overnight travel required.

Pay

The base compensation range for this position is $225,000 to $285,000. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and/or company vehicles depending on the position's level or other company factors.

Benefits

• Medical, dental, and vision coverage.
• Life insurance and disability insurance.
• 401(k) savings plan and flexible spending accounts.
• Employee assistance program and tuition reimbursement program.
• Voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance, and auto/home insurance.
• Time off pursuant to sick time policy, flexible vacation policy, and parental leave policy.