TakedaPharmaceutical Nordics AB · 10 hours ago
Regulatory Compliance, Senior Manager
Boston, MA
Full-time
Hybrid
Senior Level
$137K/yr - $215K/yr
6+ years expTakeda Pharmaceutical Nordics AB is dedicated to transforming patient care through innovative therapies. The Regulatory Compliance, Senior Manager will ensure regulatory approval for products, maintain licenses, and oversee compliance measures while interpreting regulatory developments and guiding the organization in adhering to standards.
Pharmaceuticals
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
Qualification
Required
BSc degree, preferred; BA accepted
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
Preferred
Advanced scientific degree (MSc, PhD, or PharmD) preferred
Benefits
Medical, dental, vision insurance
401(k) plan and company match
Short-term and long-term disability coverage
Basic life insurance
Tuition reimbursement program
Paid volunteer time off
Company holidays
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation
Company
TakedaPharmaceutical Nordics AB
Takeda Pharma AB is engaged in sales marketing For USA
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase