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Planet Pharma · 15 hours ago

Senior Manager of Regulatory Affairs

Redwood City, CA

Full-time

Onsite

Senior Level

5+ years exp

Planet Pharma is seeking a Senior Manager of Regulatory Affairs to provide regulatory advice and manage various Regulatory Affairs activities. The role involves coordinating submissions to global National Health Authorities and ensuring compliance to avoid business interruptions.

BiotechnologyHealth CarePharmaceutical

H1B Sponsor Likely

Responsibilities

Manage planning, preparation, coordination, and submission of regulatory documents to global National Health Authorities. Such submissions may include Clinical, Preclinical, or CMC content

Correspond and collaborate with RevMed colleagues and departments to achieve alignment

Function as a Regulatory Affairs subject matter expert member of cross-functional teams, including study teams and submission teams

Perform regulatory research to inform business strategy. Assess and communicate risks

Assure that there are no significant interruptions to the business due to regulatory compliance issues

Collaborates across the organization at all levels, across functional groups, and with executive management

Develop regulatory strategies to inform associated budgets, tools and specialized support necessary for efficient operations

Establish collaborative and effective relationships with colleagues in Clinical, Clinical Operations and Clinical Research Organizations to ensure cross-functional alignment and team effectiveness

Qualification

Regulatory Affairs expertiseUS FDA regulationsSuccessful submissionsEU EMA regulationsIND/NDA filingsInterpersonal skillsOrganizational skillsCommunication skills

Required

Bachelor's Degree in a relevant field and at least 5 years of direct Regulatory experience

Strong working knowledge of US FDA Pharmaceutical regulations and guidance

Proven track record of successful submissions within a regulatory environment

Exceptionally strong team player with excellent interpersonal and communication skills

Detail-oriented with strong organizational skills and high-quality standards

Preferred

Knowledge of EU EMA and Rest Of The World Pharmaceutical regulations and guidance preferred

Direct experience with IND/NDA filings

Company

Planet Pharma

Planet Pharma is a pharmaceuticals company.

Founded in 2009

Northbrook, Illinois, USA

1001-5000 employees

http://planet-pharma.com

H1B Sponsorship

Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2022 (3)

2021 (5)

2020 (5)

Funding

Current Stage

Late Stage

Leadership Team

Cynthia Lewis

Senior Executive Recruiter, Life Sciences - PPG Advisory Partners

Emma Morris

President, PPG Advisory Partners

Company data provided by crunchbase