This innovative, commercial-stage biopharmaceutical company is based in China and the United States. They are seeking a Regulatory Affairs Executive Director who can lead the development and implementation of Regulatory strategy in the U.S. Reporting into the SVP of Regulatory Affairs, you will work closely with cross-functional teams and interact directly with US Health Authorities. This company offers a strong development pipeline, excellent funding, competitive compensation, and flexible work arrangements. This is an onsite position which can be located in either their South San Francisco or Cambridge MA offices.
Responsibilities:
- Develop and implement Regulatory strategy for oncology and non-oncology programs in the United States.
- Serve as the US Regulatory Lead for one or more programs, leading the planning and execution of regulatory submissions for those programs.
- Represents the company as point of contact with US regulatory authorities.
- Ensure compliance with all appropriate government regulations and industry guidelines.
- Interpret regulations, policies and guidelines and advises cross-functional teams on Regulatory requirements to support development.
- Anticipate regulatory obstacles and emerging issues throughout the development lifecycle and create solutions.
- Oversee and manage the preparation of regulatory submissions.
- Provide risk assessments as needed.
- Work collaboratively with cross-functional teams to resolve complex project issues.
- Review documents for regulatory submissions with attention to detail for quality, regulatory compliance, technical merit, and strategic alignment.
- Maintain clear communication and professional relationships with functional areas inside and outside of Regulatory.
Required Qualifications:
- Advanced degree such as MS, PhD, or Pharm D preferred.
- 15 or more years of experience in Regulatory Affairs for pharmaceutical drugs and/or biologics.
- Must have strong Regulatory experience with oncology programs.
- Proven track record of successful interactions with US FDA.
- Must have direct experience with IND filings. Experience in preparing major drug applications (NDA, BLA, etc.) highly desired.
- Thorough understanding of drug development process and experience collaborating with R&D to ensure success of programs.
- Strong working knowledge of electronic document and submission standards and requirements applicable to the US regulatory environment.
- Hands-on Regulatory project management experience.
- Extensive knowledge of regulatory requirements and regulations, with ability to strategically interpret and communicate requirements.
- Flexibility with ability to set priorities, work independently, and deliver results in a timely manner.
- Ability to adapt and adjust to new information or changing priorities.
- Strategic thinker with the ability to generate creative solutions to complex problems.
- Strong interpersonal, communication and presentation skills.
- Excellent organization and operational skills including planning, organizing and the ability to lead and influence others across all functions and levels within the organization.
NOTE: This role can be based in either South San Francisco, CA or Cambridge, MA. Only local candidates in each market will be considered.
The budgeted salary range for this position is $275,000 to $300,000 plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate’s skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of remuneration.