Senior Director – Global Regulatory Affairs, Oncology

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee one or multiple Global Regulatory Teams within the Global Regulatory Affairs division.

• Formulate thorough global regulatory strategies for complex oncology programs.

• Propel product development, global registration, regional labeling, and interactions with regulatory agencies.

• Serve as a representative of Global Regulatory Affairs on product teams and commercialization governance bodies.

• Create Global Regulatory Strategic Plans and contribute insights to Global Strategic Plans.

• Identify and convey regulatory risks, as well as strategies for mitigation and contingencies.

• Offer regulatory guidance for the development of core data sheets.

• Direct the planning and execution of global regulatory submissions, which include clinical trial applications, marketing applications, and label extensions.

• Ensure that global product communications and submission documents adhere to evidence-based consistency.

• Keep abreast of global regulations, guidance, and the regulatory landscape, advising teams on potential implications.

• Evaluate regulatory mechanisms like expedited studies, Orphan Drug Designation, Fast Track Designation, accelerated approvals, compassionate use, and pediatric plans.

• Lead both formal and informal communications and interactions with regulatory agencies.

• Represent Amgen Regulatory on external product-level partnership teams.

• Spearhead initiatives and improvements in regulatory processes.

⛳️ Requirements

• Doctorate degree with 5 years of regulatory experience in biotech or science, or a Master’s degree with 9 years, or a Bachelor’s degree with 11 years of experience.

• A minimum of 5 years experience in direct people management and/or leading teams, projects, programs, or directing resource allocation.

• Desired contemporary experience in oncology.

• Proven ability to manage regulatory aspects of highly complex late-stage development programs.

• Prior experience leading a Regulatory team for the submission and approval of an original marketing application and/or a significant new indication supplemental application.

• Capability to lead and cultivate effective teams.

• Excellent oral and written communication skills.

• Proficient in understanding and conveying scientific/clinical information.

• Ability to foresee and address future strategic challenges and uncertainties.

• Competence in resolving conflicts and devising actionable strategies.

• Cultural awareness and sensitivity to achieve worldwide outcomes.

• Skills in planning, organizing, prioritizing, and managing multiple activities.

• Capacity to make complex decisions and tackle problems.

• Proficiency in navigating ambiguity.

• Organizational astuteness.

• Strong negotiation skills.

• Sponsorship for this position is not assured.

🏝️ Benefits

• A comprehensive employee benefits package.

• Retirement and Savings Plan with generous contributions from the company.

• Group medical, dental, and vision coverage.

• Life and disability insurance.

• Flexible spending accounts.

• Discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models when feasible.

• Opportunities for career development.

• Support for work/life balance.