Senior Director, Regulatory Affairs
Location
United States
Posted
25 days ago
Salary
$276.4K - $287.5K / year
Seniority
Lead
No structured requirement data.
Job Description
Senior Director, Regulatory Affairs
AVENZO THERAPEUTICS INC
Role Description The Senior Director, Regulatory Affairs will have the opportunity to shape both program-level strategy and the evolving regulatory function within a dynamic, mission-driven organization. This individual will be responsible for primary authorship and supporting regulatory activities, preparing regulatory submissions and ensuring compliance with global regulatory requirements. - Develop and execute U.S. and global regulatory strategies for one or more solid tumor oncology programs across the clinical development lifecycle, aligned with corporate and program objectives. - Serve as the Regulatory Affairs lead on cross‑functional program teams, providing regulatory guidance to Clinical, CMC, Biometrics, Pharmacovigilance, Quality, and other stakeholders. - Lead the strategic planning, review, and execution of regulatory submissions and maintenance activities (e.g., INDs, CTAs, amendments, briefing packages, and, as applicable, BLAs/MAAs), ensuring compliance with global regulatory requirements. - Assess and pursue oncology-specific expedited programs and designations, including Fast Track, Breakthrough Therapy Designation, Orphan Drug Designation, Accelerated Approval, and EMA PRIME, as appropriate for solid tumor indications. - Lead and coordinate health authority interactions, including meeting strategy, preparation and oversight of briefing documents, responses to requests for information, and management of post‑meeting commitments. - Conduct regulatory risk assessments and gap analyses; identify potential issues and develop mitigation strategies to support successful regulatory outcomes. - Provide regulatory leadership in the assessment of emerging clinical data and operational activities, evaluating regulatory impact and advising on strategy adjustments as needed. - Contribute to and/or lead the development and review of key regulatory documents, including clinical protocols and clinical and nonclinical study reports. - Drive high‑quality execution of regulatory deliverables, including alignment of timelines, content consistency across documents, and adherence to internal standards and best practices. - Translate evolving global regulatory guidance and regulatory intelligence into actionable recommendations for program teams and senior leadership. - Support the growth and scalability of the Regulatory Affairs function through process improvement, cross‑functional alignment, and mentoring of internal team members and external partners, as appropriate. - Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders. - Strong analytical and problem-solving abilities, with a strategic mindset. - This position requires periodic/regular travel, including up to 10% of work time, which may include overnight travel. Qualifications - Bachelor’s degree required, advanced medical or life sciences or a related area degree preferred (e.g., MS, Ph.D.) with 12+ years of regulatory affairs experience in the life sciences industry or an equivalent combination of academic and industry experience. - Direct experience supporting early-stage (pre-IND to Phase 1/2) solid tumor oncology programs. - Familiarity with multiple oncology modalities (e.g., small molecules, biologics, ADCs). - Demonstrated ability to develop, lead, and implement global regulatory strategies for complex development programs across multiple phases of the product lifecycle. - Extensive knowledge of U.S. and international regulatory requirements, including FDA and EMA regulations, guidance, and industry standards applicable to oncology development programs. - Proven experience leading major regulatory submissions and global filing activities (e.g., INDs, CTAs, and, as applicable, BLAs, MAAs, NDAs/NDSs). - Demonstrated success leading regulatory interactions with health authorities, including briefing package development, response strategy, and negotiation of regulatory positions and commitments. - Strong track record of independent decision‑making, regulatory risk identification, and development of mitigation strategies affecting program and portfolio outcomes. - Demonstrated ability to influence and lead cross‑functional teams in a matrix environment, providing strategic regulatory guidance to Clinical, CMC, Biometrics, Pharmacovigilance, and related functions. - Strategic thinker with strong analytical judgment, problem‑solving skills, and the ability to thrive in a fast‑paced, evolving biotech environment. - Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders. - Strong analytical and problem-solving abilities, with a strategic mindset. - This position requires periodic/regular travel, including up to 10% of work time, which may include overnight travel. Benefits - Eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life and AD&D insurance. - Additional benefit programs include short-term and long-term disability insurance, flexible spending accounts, health savings accounts, and voluntary insurance programs, including voluntary life, AD&D accident, and critical illness. - Enrollment in the Company’s 401(k) plan. - Accrue 10 hours of paid vacation time every month and accrue 1 hour of paid sick leave for every 30 hours worked. - Enjoy 17 paid holidays each calendar year, including a winter closure, subject to applicable Company policies.
Related Guides
Related Categories
Related Job Pages
More Compliance Jobs
• Oversee safe handling and storage of lithium batteries • Ensure compliance with international and domestic regulations • Develop and deliver training for warehouse staff • Conduct regular safety audits
Trade Compliance Specialist
Harbor Freight ToolsHarbor Freight Tools is a family-owned, national retail chain on a mission to offer top-quality tools at competitive prices. Past flexible hiring at the award-winning company has b
Trade Compliance Specialist - Remote 176781BR 26677 Agoura Road Calabasas CA Job Description The Trade Compliance Specialist is responsible for pre-importation reviews and post-importation audits/actions for applicable regulatory requirements and associated tariffs as well as risk and cost mitigation, thereof. The role reports to the Manager Trade Compliance Manger in the Imports Department and will work closely with Import Operations, Corporate Social Responsibility, Global Sourcing, Product Compliance, Quality Assurance, Legal, Accounting, Security, and Transportation to ensure compliance to all applicable rules and regulations of imported product as well as supply chain security and UFLPA guidelines. May involve travel, domestic & international. Duties and Responsibilities - Provide compliance guidance and support while mitigating risks and costs for all aspects of Imports including, but not limited to, product classification, country of origin determination, trade agreements, marking, labeling (product and packaging), antidumping procedures/cases, other government agency requirements, and transportation requirements in accordance to Code of Federal Regulations and all other applicable rules and regulations - Maintain accuracy, completeness, and alignment of product-related import data in all systems - Perform audits and assess internal procedures and systems to maintain status in the CTPAT Trade Compliance program (formerly known as Importer Self-Assessment) - Execute, monitor, and report annually on global security initiatives for Customs Trade Partnership Against Terrorism program - Provide support for Import Operations and all CBP as well as PGA transactions - Initiate reconciliation of entry discrepancies, PSCs as necessary and prepare/submit protests as required - Request U.S. Customs binding rulings and prepare Department of Commerce scope inquiries - Keep updated on all U.S. Customs and other government agency compliance changes in regulations - Maintain and develop other compliance tracking tools and documented procedures - Read, analyze and interpret complex documents - Additional duties as assigned Scope (Required) - Supervises staff – None - Financial Scope – Action taken effect duties/tariffs paid - Organizational Scope – As part of the Global Sourcing Division, will need to work closely with the rest of Global Sourcing, as well as Product Compliance, Quality Assurance, Legal, Costing, Security, and Transportation - Decision Making – Decisions made as a team with input from other Trade Compliance Specialists - Travel – Domestic and international travel may be required. The anticipated salary range for this position is $69,500– $104,200 depending on location, knowledge, skills, education and experience. This position is also eligible for an annual discretionary bonus. In addition, we offer comprehensive and competitive benefits to Associates (and their families) such as medical, dental, vision, life insurance, short-term and long-term disability. Eligible Associates are able to enroll in our company’s 401k plan. Associates will accrue paid time off up to 236 hours per year (inclusive of PTO, floating holidays, and paid holidays). Paid sick time up to 80 hours per year unless otherwise required by law. Requirements Job Qualifications – Education and Experience (Required) - Bachelor’s degree in International Relations, International Business, or other related studies highly preferred - Customs broker license - Minimum 3-5 years experience with customs house broker and/or importer (experience with both is preferred) - Must have strong working knowledge of HTSUS, CFRs, CBP directives and bulletins - Understanding of the import process from point of origin, shipping, entry and post entry processes and procedures - Proficiency utilizing spreadsheets to analyze large data sets - Effective communication, verbal and written Physical Requirements General office environment requiring ability to: - stand, walk, sit for extended periods of time - speak and listen to others in person and over the phone - use keyboard and read from computer screen and reports - lift up to 45 lbs. About Harbor Freight Tools We’re a 45 year-old, $8 billion national tool retailer with the energy, enthusiasm, and growth potential of a start-up. We have over 1,600 stores in 48 states across the country and are opening several new locations every week. We offer our customers more than 7,000 tools and accessories, from hand tools and generators to air and power tools, from shop equipment to automotive tools. We provide our customers with the right tool for the right job at the right price, always delivering quality and value.
Senior Consultant – Regulations Expert, Packaging
Anthesis GroupAnthesis is the world’s leading purpose driven, digitally enabled, science-based activator.
• Manage multiple concurrent projects, delivering high-quality, high-impact work that drives results for Anthesis clients. • Provide technical leadership and guidance to both clients and colleagues on leading standards and trends, integrating this expertise into projects, proposals, and service evolution. • Draft comprehensive reports and presentations that distill complex information into key messages to inform strategic decision-making. • Execute detailed regulatory deep-dives to help clients interpret and action critical requirements, future-proof their operations, and plan for new legislative initiatives. • Conduct regulatory readiness assessments focusing on existing and upcoming packaging frameworks. • Perform landscape reviews, including sustainable packaging regulations and competitor commitments. • Utilize data analysis to identify gaps or inaccuracies, developing well-reasoned approaches and assumptions to bridge them. • Lead and grow client relationships, acting as the primary point of contact and trusted advisor with a relentless focus on their sustainability success. • Develop and deliver high-impact proposals in collaboration with client managers, while also generating leads with existing clients through a deep understanding of their business goals. • Proactively monitor and analyze emerging trends in sustainable packaging, supply chains, and innovative materials, translating these insights into actionable client recommendations. • Collaborate with global experts to represent Anthesis at industry-leading conferences, fostering strategic connections and partnerships. • Drive the creation of innovative thought leadership content, transforming complex concepts into accessible and engaging materials for diverse audiences.
Senior Consultant – Regulations Expert, Packaging
Anthesis GroupAnthesis is the world’s leading purpose driven, digitally enabled, science-based activator.
- Manage multiple concurrent projects, delivering high-quality, high-impact work that drives results for Anthesis clients. - Provide technical leadership and guidance to both clients and colleagues on leading standards and trends, integrating this expertise into projects, proposals, and service evolution. - Draft comprehensive reports and presentations that distill complex information into key messages to inform strategic decision-making. - Execute detailed regulatory deep-dives to help clients interpret and action critical requirements, future-proof their operations, and plan for new legislative initiatives. - Conduct regulatory readiness assessments focusing on existing and upcoming packaging frameworks. - Perform landscape reviews, including sustainable packaging regulations and competitor commitments. - Utilize data analysis to identify gaps or inaccuracies, developing well-reasoned approaches and assumptions to bridge them. - Lead and grow client relationships, acting as the primary point of contact and trusted advisor with a relentless focus on their sustainability success. - Develop and deliver high-impact proposals in collaboration with client managers, while also generating leads with existing clients through a deep understanding of their business goals. - Proactively monitor and analyze emerging trends in sustainable packaging, supply chains, and innovative materials, translating these insights into actionable client recommendations. - Collaborate with global experts to represent Anthesis at industry-leading conferences, fostering strategic connections and partnerships. - Drive the creation of innovative thought leadership content, transforming complex concepts into accessible and engaging materials for diverse audiences.


