Regulatory Compliance, Senior Manager

Takeda • Boston, MA

17h • $137,000 - $215,270 • Hybrid

About The Position

About the role: The Plasma-Derived Therapies (PDT) R&D Organization is dedicated to bringing forward new plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. The Regulatory Compliance, Senior Manager ensures that the organization gains regulatory approval for new products and product amendments, and maintains the currency of product licenses and permits. This role involves monitoring regulatory developments, ensuring compliance, and preparing necessary documentation to support Takeda's mission. How you will contribute: As a Regulatory Compliance, Senior Manager in our PDT organization, you will ensure the organization is aware of and compliant with legislation and regulations pertaining to the business Monitor and interpret regulatory developments, determining the impact 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 from the manager Coach, review, and delegate work to lower-level professionals Serve as a consultant to management and an external spokesperson on major matters

Requirements

• BSc degree, preferred; BA accepted. Advanced scientific degree (MSc, PhD, or PharmD) preferred.
• 6+ years of pharmaceutical industry experience. This is inclusive of 4 years of regulatory compliance or combination of 4+ years regulatory and/or related experience.
• Proficient in regulatory compliance, capable of advising others and handling highly complex compliance issues independently.
• Advanced proficiency in toxicology, capable of handling complex cases and offering guidance to others based on a deep understanding of chemical interactions with organisms.
• Performs advanced Environment Health and Safety tasks independently, capable of coaching others and making improvement recommendations.
• Leads new product development projects, advising on market analysis and customer needs, capable of managing complex situations and guiding others.
• Capable of independently managing and improving organizational structures and processes, can coach others in effective organization.
• Leads project management efforts in complex situations, advising and coaching others, and contributing to process improvements.
• Advanced writing ability, capable of crafting well-structured content for a variety of complex scenarios and can mentor others in improving their writing skills.
• Fully capable of executing complex risk analysis independently, advising on mitigation strategies, and coaching others in risk analysis methods and principles.
• Fully capable of managing time in highly complex situations and can coach others on time management techniques and improvements.
• Excellently manages tasks requiring high attention to detail, independently addresses complex scenarios, and advises others on maintaining precision.
• Skilled in creating and delivering persuasive and impactful presentations in a variety of complex situations, able to mentor others in developing their presentation skills.
• Advanced in auditing, capable of handling highly complex situations, making improvement recommendations, and coaching others.
• As an expert professional within the organization, you develop innovative solutions to complex problems aligned with organizational objectives.
• Your work involves addressing intricate issues, requiring in-depth analysis and judgment.
• You also engage with key contacts outside your expertise area and contribute to the development of new concepts and standards.
• Operating with considerable autonomy, you serve as a consultant to management and an external spokesperson on major matters, often working independently and leading function teams or projects.
• Additionally, you play a role in training and mentoring junior staff.

Responsibilities

• Ensure the organization is aware of and compliant with legislation and regulations pertaining to the business
• Monitor and interpret regulatory developments, determining the impact 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 from the manager
• Coach, review, and delegate work to lower-level professionals
• Serve as a consultant to management and an external spokesperson on major matters

Benefits

• U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level