Regulatory Compliance, Senior Manager
Takeda
2 months ago
Remote friendly (Boston, MA)
United States
$137,000 - $215,270 USD yearly
Corporate Functions
Responsibilities:
- Ensure the organization is aware of and compliant with legislation and regulations pertaining to the business.
- Monitor and interpret regulatory developments; assess impacts on business operations and compliance programs.
- Implement compliance measures and ensure adherence to regulatory standards.
- Prepare, review, and approve regulatory compliance documents for internal and external audiences.
- Manage large projects or processes with limited oversight.
- Coach, review, and delegate work to lower-level professionals.
- Serve as a consultant to management and act as an external spokesperson on major matters.
Minimum Requirements/Qualifications:
- BSc preferred (BA accepted).
- Advanced scientific degree preferred (MSc, PhD, or PharmD).
- 6+ years of pharmaceutical industry experience (including 4+ years regulatory compliance, or a combination of 4+ years regulatory and/or related experience).
- Proficient in regulatory compliance; able to advise others and handle highly complex compliance issues independently.
- Ability to perform advanced Environment Health and Safety tasks independently; capable of coaching others and recommending improvements.
- Lead new product development projects and advise on market analysis and customer needs.
- Independently manage and improve organizational structures/processes; coach others.
- Lead project management efforts in complex situations; contribute to process improvements.
- Advanced writing skills for complex scenarios; mentor others.
- Execute complex risk analysis independently; advise mitigation strategies and coach others.
- Manage time in highly complex situations; coach others.
- Strong attention to detail and ability to maintain precision in complex scenarios.
- Skilled in creating and delivering persuasive presentations; mentor others.
- Advanced auditing skills; recommend improvements and coach others.
- Develop innovative solutions aligned with organizational objectives; operate with considerable autonomy; train and mentor junior staff.
- Ensure the organization is aware of and compliant with legislation and regulations pertaining to the business.
- Monitor and interpret regulatory developments; assess impacts on business operations and compliance programs.
- Implement compliance measures and ensure adherence to regulatory standards.
- Prepare, review, and approve regulatory compliance documents for internal and external audiences.
- Manage large projects or processes with limited oversight.
- Coach, review, and delegate work to lower-level professionals.
- Serve as a consultant to management and act as an external spokesperson on major matters.
Minimum Requirements/Qualifications:
- BSc preferred (BA accepted).
- Advanced scientific degree preferred (MSc, PhD, or PharmD).
- 6+ years of pharmaceutical industry experience (including 4+ years regulatory compliance, or a combination of 4+ years regulatory and/or related experience).
- Proficient in regulatory compliance; able to advise others and handle highly complex compliance issues independently.
- Ability to perform advanced Environment Health and Safety tasks independently; capable of coaching others and recommending improvements.
- Lead new product development projects and advise on market analysis and customer needs.
- Independently manage and improve organizational structures/processes; coach others.
- Lead project management efforts in complex situations; contribute to process improvements.
- Advanced writing skills for complex scenarios; mentor others.
- Execute complex risk analysis independently; advise mitigation strategies and coach others.
- Manage time in highly complex situations; coach others.
- Strong attention to detail and ability to maintain precision in complex scenarios.
- Skilled in creating and delivering persuasive presentations; mentor others.
- Advanced auditing skills; recommend improvements and coach others.
- Develop innovative solutions aligned with organizational objectives; operate with considerable autonomy; train and mentor junior staff.