Exel

Exel

Associate Regulatory Affairs Strategy Director (Oncology)

Alameda, CA · Director

Sponsorship not specified$195k-$278kDetected 8 days ago
HRFDA RegulatoryResearchCollaborationRegulatory Affairs

About the role

  • Ensures timely preparation of organized, consistent, and scientifically valid submissions.
  • ESSENTIAL DUTIES AND RESPONSIBILITIES: - Interact directly with regulatory authorities. - Conduct effective and timely regulatory intelligence and research to provide guidance to study and asset teams.
  • Provides timely and appropriate information updates.

Responsibilities

  • Work with external vendors to plan, review, prepare, submit, and maintain CTAs in Europe, Asia, and other regions.
  • Contribute to the implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs.
  • Lead multiple assets and/or studies as assigned.
  • Communicates clearly with stakeholders to reduce regulatory risk and drive the implementation of appropriate mitigation strategies.

Requirements

  • Bachelor's degree in related discipline and a minimum of eleven years of related experience
  • Master's degree in related discipline and a minimum of nine years of related experience
  • PhD degree in related discipline and a minimum of five years of related experience
  • It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

Skills

  • Capable of managing the execution of multiple tasks.
  • Ensures appropriate prioritization and execution for area of responsibility.
  • Proactively anticipates, prioritizes and resolves task-related challenges.
  • Travel approximately 10%
  • Education/Experience:
  • Bachelor's degree in related discipline and a minimum of eleven years of related experience; or,
  • Master's degree in related discipline and a minimum of nine years of related experience; or,
  • PhD degree in related discipline and a minimum of five years of related experience; or,
  • Equivalent combination of education and experience.
  • Experience/The Ideal for Successful Entry into Job:

Compensation

  • The base pay range for this position is $195,000 - $277,500 annually.
  • The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location.
  • Oversee the preparation and completion of regulatory submissions (electronic and paper), including investigational new drug applications, supplements and amendments, IND safety reports, annual reports/ DSURs, other routine amendments, and new drug applications (NDA)/biologics license applications (BLA).

Benefits

  • Responsible for the development and implementation of global regulatory strategies that align with asset and corporate goals as well as health authority requirements.
  • The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
  • Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.

Company info

  • Any resumes submitted through the website or directly by recruiters or staffing agencies that do not meet the above-mentioned criteria will be considered unsolicited and the company will not be responsible for any related fees.
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