#WeareBiotech

Senior Director, Global Regulatory Affairs – Obesity

ComplianceComplianceFull TimeRemoteTeam 10,001+Since 1980H1B SponsorCompany Site LinkedIn

Location

United States

Posted

115 days ago

Salary

$216.8K - $259.6K / year

Postgraduate Degree5 yrs expEnglish

Job Description

• Support products in the Obesity Therapeutic Area • Provide Regulatory leadership to cross-functional teams for high complexity programs • Independently develop a comprehensive regulatory strategy for one or more high complexity programs • Develop and implement global regulatory product strategies designed to achieve approval and target product labeling for prioritized assets • Represent GRA on the product team and other key commercialization governance bodies • Independently develop the Global Regulatory Strategic Plan and provide regulatory input into the product’s Global Strategic Plan • Identify and communicate regulatory risks • Lead the planning and implementation of global regulatory filings • Monitor and assess the impact of relevant global regulations • Ensure consistency of evidence-based global product communication • Clearly and succinctly communicate regulatory strategies and associated risks to the organization • Lead GRTs and product teams in formal and informal communications with regulatory agencies

Job Requirements

Doctorate degree and 5 years of regulatory experience in biotech or science OR Master’s degree and 8 years of regulatory experience in biotech or science OR Bachelor’s degree and 10 years of regulatory experience in biotech or science
Contemporary obesity experience desired
Demonstrated ability to lead regulatory aspects of highly complex programs in late development
Previous experience leading a Regulatory team for submission and approval of an original marketing application and/or major new indication supplemental application
Ability to lead and build effective teams
Strong communication skills - both oral and written
Ability to understand and communicate scientific/clinical information
Ability to anticipate and mitigate against future strategic issues and uncertainties
Ability to resolve conflicts and develop a course of action
Cultural awareness and sensitivity to achieve global results
Planning and organizing abilities
Able to prioritize and manage multiple activities
Ability to make complex decisions and solve problems
Ability to deal with ambiguity
Organizational savvy
Negotiation skills

Benefits

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible