20 Best senior director of product management jobs (Hiring Now!)

Director of Regulatory Affairs- Drug/Device Combination Products
Confidential —Irvine, CA
Prepare and review of regulatory submissions, including clinical trial applications, IND, meeting packages for FDA, EMA, technical files/design dossier and…
$175,000 - $220,000 a year
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Director of Information Technology
Worth County Auditor —Northwood, IA
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Director of Marketing
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Director of Product Management
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From $125,000 a year
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Technology Director
Lourdes Academy of Oshkosh, WI —Oshkosh, WI
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Director of Product Management and Marketing -Hardware
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VP, Product Management
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Senior Director of Product Design, Account Management, Authentication and Transactions
NBCUniversal —New York, NY
A degree in design, computer science, human factor design preferred. Provide creative thought leadership and drive UX design solutions by combining industry…
$195,000 - $250,000 a year
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4d
Director, Product Management
MAPFRE Insurance —Webster, MA
Education: Bachelor's Degree or professional level of knowledge in a specialized field, or equivalent related experience preferred.
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Senior Director of Product Management
Hinge Health —San Francisco, CA
Bachelor's degree in Computer Science, Engineering, or Medical/Scientific field. The ideal candidate will possess deep consumer tech product experience and…
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Senior Director of Product Management, Growth
Workiva —Remote
As a key leader on the growth team, this role supports our Innovation to Incubation (I2I) process by driving early ideation, discovery, and incubation to help…
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VP IT Infrastructure and Operations
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Bachelor’s or master's degree in computer science, information systems, business administration, related field, or equivalent work experience.
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IT Director
Kelly Roofing —Naples, FL
Holder of a Dynamics 365 certification, affirming expertise in the field. Provide technical support and conduct comprehensive training sessions for end-users,…
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Director of Product Management
HarperDB, Inc. —Remote
Project or program management certification (PMP, ScrumMaster, etc.). Create and maintain comprehensive documentation for product features, user guides, and…
$175,000 - $205,000 a year
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Director of Product Management
BriteCore —San Francisco, CA
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Estimated: $195K - $247K a year
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4d

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Director of Regulatory Affairs- Drug/Device Combination Products

Confidential Irvine, CA

Quick Apply

Job Details

Full-time $175,000 - $220,000 a year 12 days ago

Benefits

Health insurance
Dental insurance
401(k)
Paid time off
Vision insurance

Qualifications

Filing
Master's degree
Bachelor's degree
Product development
Clinical trials
Chemistry, manufacturing & controls
Design controls
Manufacturing
Leadership
Communication skills
FDA regulations
10 years

Full Job Description

We are a life sciences recruitment agency doing a search for a growing organization in Southern California with "Best in Class" drug device combination products that are supporting global eye care!

Summary:

We are seeking a strong Director of Regulatory Affairs. This position has the responsibility for supporting the VP, Regulatory Affairs in developing and implementing global regulatory strategy, primarily on drug-device combination products, or prescription pharmaceuticals in the US, EU, and international markets. They will also be responsible for addressing and resolving regulatory issues in preclinical, CMC, clinical and commercial development programs. The position interacts with all levels in the organization, participating in discussions with management and providing strategic regulatory guidance.

Essential Duties & Responsibilities:

Support the VP, Regulatory Affairs to develop and implement global regulatory strategies, primarily on drug-device combination products or prescription pharmaceuticals.
Provide strategic regulatory guidance to interdisciplinary project teams, aligning with FDA/MOH regulatory requirements, FDA/ICH guidelines, and industry best practices.
Proactively identify regulatory, quality, and technical issues and recommend / implement solutions to resolve them.
Participate in FDA and HA meetings, including FDA Pre-IND, EOP2, EOP3, Pre-NDA, Type C/D meetings, Pre-Sub meetings, EMA Scientific Advisory meetings.
Prepare and review of regulatory submissions, including clinical trial applications, IND, meeting packages for FDA, EMA, technical files/design dossier and other regulatory agencies.
Manage and facilitate submission deliverables and follow-up with team members, ensuring that all applications are filed in accordance with predetermined timelines.
Collaborate closely with cross-functional teams, including R&D, Clinical Operations, Quality Assurance, and Clinical teams, to ensure regulatory compliance and successful product development.
Interact and coordinate with R&D staff (CMC and Engineering) and consultants to ensure compliance to applicable Design Control and pharmaceutical requirements (for drug/device combination products).
Stay abreast of regulatory trends, changes, and requirements in the pharmaceutical industry, providing strategic guidance and recommendations to senior management on regulatory matters.

Qualifications Required For Position:

Bachelor's degree in a relevant scientific discipline; advanced degree (e.g., Master's preferred.)
Minimum of 10 years of experience in regulatory affairs within the pharmaceutical industry, with a focus on drug and drug/device combination products.
In-depth knowledge of US, EU, and international regulatory requirements and guidelines for drug and drug/device combination products, including FDA/MOH regulations and FDA/ICH guidelines.
Experience in preparing and filing US IND/amendments, annual reports, and briefing books.
Knowledge of pharmaceutical development and CMC requirements for INDs.
Thorough understanding of the CFR, FDA/ICH guidelines, GxP and cGMP as they pertain to pharmaceutical development and manufacturing.
Knowledge of design controls, device development (Class III) and drug-device combination product development a plus.
Knowledge of regulatory CMC and product development requirements at various stages of development.
Proven track record of successful regulatory submissions, meetings, and interactions with regulatory agencies.
Strong leadership, communication, and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external partners.
Experience in regulatory strategy development, regulatory compliance, and leading regulatory activities for sustained release drug and drug/device combination products.
Ability to work in a fast-paced, dynamic environment and manage multiple projects simultaneously while maintaining attention to detail and quality.

Job Type: Full-time

Pay: $175,000.00 - $220,000.00 per year

Benefits:

401(k)
Dental insurance
Health insurance
Paid time off
Vision insurance

Experience level:

10 years

People with a criminal record are encouraged to apply

Experience:

FDA regulations: 3 years (Preferred)

Ability to Commute:

Irvine, CA 92618 (Required)

Ability to Relocate:

Irvine, CA 92618: Relocate before starting work (Required)

Work Location: Hybrid remote in Irvine, CA 92618

Quick Apply

senior director of product management jobs

Director of Regulatory Affairs- Drug/Device Combination Products

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Director of Plumbing and Hardware

Technology Director

Director of Information Technology

Director of Marketing

Director of Product Management

Product Manager (Food & Supplements)

Director of Product Development

Technology Director

Director of Product Management and Marketing -Hardware

VP, Product Management

Senior Director of Product Design, Account Management, Authentication and Transactions

Director, Product Management

Senior Director of Product Management

Senior Director of Product Management, Growth

VP IT Infrastructure and Operations

IT Director

Director of Product Management

Director of Product Management

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