Senior Director, Regulatory Affairs - 21262

Job Description

Job Description

Senior Director, Regulatory Affairs - Simply Biotech

OVERVIEW

Are you looking for a new career opportunity with an exciting biotech company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below.

Immediate opening for a Senior Director, Regulatory Affairs in Lenoir, NC who possesses:

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Biology, Regulatory Science, or a related scientific discipline required
• 10+ years of progressive CMC Regulatory Affairs experience, including 5+ years of people leadership in the pharmaceutical, biologics, or biotechnology industry
• Strong experience with biologics regulations, cGMP requirements, CMC regulatory requirements, Health Canada regulations, and North American regulatory frameworks
• Experience supporting BLAs, INDs, manufacturing changes, lifecycle management, and post-approval regulatory submissions

FULL DESCRIPTION: We are seeking a Senior Director, Regulatory Affairs to provide strategic leadership for Regulatory Affairs activities across the Americas region. This role is responsible for developing and executing regulatory strategies that support commercial biologic products, manufacturing operations, lifecycle management, and future development programs while ensuring compliance with applicable regulatory requirements. The ideal candidate will have strong CMC Regulatory Affairs experience, biologics expertise, hands-on regulatory submission experience, and the ability to serve as a key regulatory advisor to leadership and cross-functional teams.

The selected candidate will be responsible for:

• Leading the Regulatory Affairs function for the Americas and providing strategic direction for regulatory activities
• Developing and executing regulatory strategies supporting commercial products, manufacturing changes, lifecycle management, and business growth initiatives
• Serving as the primary regulatory advisor to the Americas Leadership Team
• Providing guidance on regulatory risks, opportunities, and strategic business decisions
• Monitoring evolving regulatory requirements, industry trends, and agency expectations
• Advising leadership on regulatory business impacts and implementation strategies
• Establishing departmental priorities, objectives, budgets, and resource plans to support organizational goals
• Serving as the primary regulatory liaison with FDA, Health Canada, USDA, and other applicable regulatory authorities as it pertains to licenses
• Supporting timely responses to agency questions, information requests, commitments, and regulatory actions
• Building and maintaining productive working relationships with regulatory authorities throughout the product lifecycle
• Providing strategic oversight for the preparation, review, and submission of BLAs, INDs, supplements, annual reports, CMC submissions, Health Canada submissions, USDA submissions, and other applicable regulatory filings
• Leading regulatory strategy for manufacturing changes, facility changes, comparability assessments, labeling changes, and post-approval lifecycle management
• Ensuring regulatory submissions are scientifically sound, technically accurate, complete, and aligned with applicable regulations and business objectives
• Evaluating product, manufacturing, packaging, testing, and labeling changes to determine regulatory impact and submission requirements
• Providing strategic oversight for U.S. and Canadian prescribing information, package labeling, and regulatory labeling compliance
• Serving as a standing member of the Compliance Review Committee and providing regulatory review and approval of promotional, medical, digital, and corporate communications
• Supporting required regulatory submissions related to promotional materials where applicable
• Collaborating with Quality, Manufacturing, Medical Affairs, Pharmacovigilance, Commercial, Clinical Development, Technical Operations, Supply Chain, Legal, and Global Regulatory Affairs
• Representing Regulatory Affairs on cross-functional project teams and governance committees
• Interpreting regulatory requirements and providing practical, risk-based recommendations
• Partnering with Global Regulatory Affairs to align regional regulatory strategies with global development and commercialization objectives
• Partnering with Quality to support regulatory inspection readiness, regulatory audits, agency inspections, and responses to inspection observations
• Providing regulatory leadership during recalls, field actions, and other regulatory events in collaboration with Quality and Legal
• Ensuring departmental compliance with applicable regulatory requirements, internal policies, and quality systems
• Identifying opportunities to improve regulatory processes, procedures, and organizational effectiveness
• Leading, mentoring, and developing the Regulatory Affairs organization
• Fostering technical excellence, accountability, collaboration, professional growth, and continuous improvement

The selected candidate will also possess:

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Biology, Regulatory Science, or a related scientific discipline required
• RAC certification preferred
• Advanced scientific or professional degree, such as M.S., Pharm.D., or equivalent, preferred
• Minimum of 10 years of progressive experience in CMC Regulatory Affairs required
• Minimum of 5 years of people leadership experience in the pharmaceutical, biologics, or biotechnology industry required
• Strong working knowledge of biologics regulations required
• Strong working knowledge of cGMP requirements, CMC regulatory requirements, ICH guidelines, Health Canada regulations, and applicable North American regulatory frameworks
• Experience supporting manufacturing changes, lifecycle management activities, and post-approval regulatory submissions
• Demonstrated experience authoring regulatory submissions in the U.S., EU, and/or Canada that were submitted to an agency for review
• In-depth working knowledge of U.S. biologics and pharmaceutical regulations and standards
• Working knowledge of U.S. and international medical device regulations
• Ability to apply business insight and understand how product approval strategy interacts with business strategy
• Strong written and verbal communication skills
• Ability to work independently and take ownership of responsibilities
• Ability to prioritize and manage several projects concurrently
• Experience coordinating large or complex projects preferred
• Demonstrated ability to collaborate, think innovatively, and seek out relevant legislation and competitive information on product lines
• Ability to lead cross-functional teams and provide practical, risk-based regulatory guidance
• Ability to work onsite or regularly support the Lenoir, NC site as needed

Physical Requirements:

• Ability to sit and work at a computer for extended periods while reviewing regulatory submissions, reports, compliance documents, labeling, and technical materials
• Ability to communicate effectively by phone, email, video meeting, and in person throughout the workday
• Ability to review detailed regulatory files, technical documents, submissions, agency correspondence, and inspection-related materials for extended periods
• Ability to occasionally stand, walk, and move throughout office, manufacturing, laboratory, or inspection areas as needed
• Ability to travel or commute to the site as needed to support regulatory activities, inspections, meetings, and cross-functional initiatives
• Ability to occasionally lift, carry, or move standard office files, regulatory documentation, and related materials

Salary Range: $190,000 to $220,000/year plus minimum 15% bonus
More information can be found at

Simply Biotech was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2025, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, Simply Biotech is expanding to new markets and hiring additional staff in existing offices.

Company Description

Simply Biotech was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2025, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, Simply Biotech is expanding to new markets and hiring additional staff in existing offices.