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Planet Pharma · 1 day ago

Director of Regulatory Affairs

Redwood City, CA

Full-time

Onsite

Director/Executive

12+ years exp

Planet Pharma is seeking a Director of Regulatory Affairs who will be accountable for the delivery of regulatory strategy for designated oncology programs. The role involves providing regulatory advice, developing strategies, and ensuring cross-functional alignment to support drug development teams.

BiotechnologyHealth CarePharmaceutical

H1B Sponsor Likely

Responsibilities

Provide clear, effective regulatory strategy as the Regulatory Study Lead for global oncology programs

Motivate, mentor and develop direct reports to ensure development and performance

Ensure late-stage oncology programs are fully resourced and anticipate regulatory needs to deliver on programming milestones

Develop robust global regulatory strategies that reflect competitive intelligence, expert input, and align with corporate goals to ensure global success

Drive consistency in regulatory approach, ensuring lessons learned across programs are applied broadly

Establish highly collaborative and effective relationships with management colleagues in Clinical Research, Clinical Operations, Regulatory Affairs, Medical Writing, Quality and other functions to ensure cross-functional alignment and team effectiveness

Qualification

Regulatory strategyOncology drug developmentHealth authority interactionsGlobal regulatory submissionsAlliance managementPlanning skillsLeadershipCommunication skillsOrganizational skills

Required

Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including regulatory strategy and leadership roles

Proven success in developing and delivering global regulatory strategies and submissions

Demonstrated success in leading health authority interactions and negotiations

Direct experience in oncology drug development including oversight of large, global Phase 3 and platform studies

Strong track record in alliance management, coordinating with external development or commercialization partners

Skilled at representing Regulatory on cross-functional teams and presenting to senior leadership

Excellent communication, planning, and organizational skills with the ability to manage multiple projects and tight deadlines

Preferred

An advanced degree is desirable

Experience with dose optimization in oncology

Prior NDA experience is highly preferred

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