2,904 Certified Compliance Ethics Professional jobs in the United States

Stallergenes Greer is a fully integrated global biopharmaceutical company specializing in the diagnosis and treatment of allergies through the development and commercialization of allergy immunotherapy (AIT) products and services.

Job Purpose

The Americas Regulatory Affairs Manager is responsible for overseeing and managing the routine operations of the regulatory affairs department as described in the Major Accountabilities of the Role Profile. In this role, the Manager ensures compliance with applicable regulatory requirements, including those from the US FDA, Health Canada, USDA, and other applicable regulatory agencies, while providing regulatory strategy and support across the business.

Major Accountabilities

• Oversee and manage all Regulatory Affairs activities to ensure the technical accuracy, quality, content and format of all regulatory submissions in the appropriate format (eCTD) to the FDA, Health Canada, USDA, and other regulatory agencies.
• Lead the preparation, submission and management of regulatory filings such as INDs, BLAs, 510(k)s and/or other market authorization applications for both existing and new products.
• Assess and address regulatory impact of product and manufacturing changes, including overseeing change control assessments.
• Plan, coordinate and participate in formal meetings, teleconferences, and written communication with regulatory agencies, ensuring timely responses to requests.
• Oversee the preparation, review, and submission of all biologic and veterinary prescribing information and product labeling, ensuring compliance with all regulatory requirements.
• Review and approve promotional and advertising materials, ensuring adherence to applicable laws, regulations, and company policies, including timely submission of materials to regulatory agencies.
• Provide regulatory strategy guidance to project teams and other departments to support product development and life cycle management.
• Act as primary liaison between the company and regulatory authorities, including the FDA, Health Canada, USDA and other applicable regulatory agencies.
• Collaborate with other departments (Quality, R&D, Manufacturing, and Commercial teams) to address product complaints, investigations, and any necessary remediation from a regulatory perspective.
• Ensure accurate product registration, listing, and maintenance of drug listings (SPL) in accordance with local and global regulatory requirements,
• Manage the regulatory database and tracking system for submissions and approvals.
• Monitor changes in regulations, laws, and enforcement activities, and assess their potential impact on company products, recommending appropriate action.
• Work with cross-functional teams to aggregate safety reports including Periodic Adverse Experience Reports (PAERs) Periodic Benefit Risk Evaluation Reports (PBRERs) and Annual Safety Reports (ASRs)
• Help with planning and implementing the Regulatory Affairs budget
• Lead, mentor, and develop regulatory team, ensuring high performance and continued professional growth.
• Manage goals and objectives of the Regulatory Affairs department to align with overall company objectives/priorities.
• Regularly review and update Standard Operating Procedures (SOPs) to maintain regulatory compliance and improve operational efficiencies.
• Assist in planning and implementing the regulatory affairs budget, ensuring efficient allocation of resources in line with department objectives.
• Prioritize and manage the department’s resources to meet regulatory deadlines and strategic goals.

Key Performance Indicators / Measures of Success

• Develop and execute comprehensive, cost-effective regulatory strategies on time and to budget.
• Deliver on-time submissions to government Agencies for compliance with regulatory commitments and lifecycle management of legacy products.
• Provide timely, high quality management reporting to enable effective decision making, and escalation/resolution of issues.

Professional Experience/Qualifications

• 5+ years of related regulatory experience in the biologics and medical device areas.
• Regulatory Affairs Certification (RAC) is preferred.
• Thorough understanding of the laws and regulations for the US FDA, Health Canada, USDA, ICH Guidelines, and any other applicable Agency.
• Thorough understanding of the eCTD format and submission.
• Must be able to interpret regulatory requirements, determine what is necessary for compliance, and effectively communicate this information to stakeholders.
• Ability to think strategically, and to interpret and act upon complex or ambiguous issues.
• Ability to inspire, motivate, and build the confidence of teams to reach goals, while pushing self and others to achieve results.
• Demonstrates leadership courage through openness to diverse views, condor in assessing and articulation difficult positions, and willingness to make changes when needed.
• Demonstrates in-depth understanding of advanced technical/scientific principles that relate to a specific product line.

Education / Experience

Minimum Education : Bachelor’s Degree in a scientific discipline or equivalent

Ideal Experience Level: 5+ years in regulatory management

Languages: English, fluent spoken and written

Travel: Infrequent travel may be required

Compensation and Benefits

Stallergenes Greer offers a highly competitive compensation package consisting of base, bonus and comprehensive benefit offerings.

Vice President / Senior Vice President - Regulatory Affairs
U.S. - Remote or Hybrid (Bay Area) | Full-time
Salary Range: $380,000 - $430,000 + Bonus + Equity

Lead the regulatory strategy behind a new era of precision medicine.

This is a rare opportunity to join a clinical-stage biotech company that's redefining how rare and genetic diseases are treated. As VP/SVP of Regulatory Affairs, you'll be the architect of global regulatory strategy-guiding breakthrough therapies from development to approval and beyond. If you're ready to lead with purpose and build something transformative, this is the move worth making.

Vice President / Senior Vice President - Regulatory Affairs
U.S. - Remote or Hybrid (Bay Area) | Full-time
Salary Range: $380,000 - $430,000 + Bonus + Equity

Lead the regulatory strategy behind a new era of precision medicine.

This is a rare opportunity to join a clinical-stage biotech company that's redefining how rare and genetic diseases are treated. As VP/SVP of Regulatory Affairs, you'll be the architect of global regulatory strategy-guiding breakthrough therapies from development to approval and beyond. If you're ready to lead with purpose and build something transformative, this is the move worth making.

Vice President / Senior Vice President - Regulatory Affairs
U.S. - Remote or Hybrid (Bay Area) | Full-time
Salary Range: $380,000 - $430,000 + Bonus + Equity

Lead the regulatory strategy behind a new era of precision medicine.

This is a rare opportunity to join a clinical-stage biotech company that's redefining how rare and genetic diseases are treated. As VP/SVP of Regulatory Affairs, you'll be the architect of global regulatory strategy-guiding breakthrough therapies from development to approval and beyond. If you're ready to lead with purpose and build something transformative, this is the move worth making.

Director, Regulatory Affairs

W2 Contract-to-Hire

Salary Range: $218,400 - $239,200 per year

Location: Redwood City, CA - Hybrid Role

Job Summary:

The Director of Regulatory Affairs is accountable for the delivery of regulatory strategy for designated programs. They will support programs and drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent, and actionable regulatory advice. The Director will support policy and process development within regulatory and cross-functionally to define a consistent approach to regulatory advice and strategy. The Director must have a thorough understanding of and be highly experienced in oncology drug development, applicable regulations, and current health authority thinking, as well as strong leadership and relationship-building ability.

Duties and Responsibilities:

• Deliver a sound regulatory strategy to program teams.
• Motivate, mentor, and develop direct reports.
• Ensure drug development programs are fully resourced for applicable stages of development. Anticipate upcoming work; ensure robust and effective regulatory strategy support.
• Ensure regulatory strategy takes account of competitive developments, expert feedback, and that advice is aligned with company goals and objectives.
• Ensure regulatory advice, policy, and decision-making are consistent across programs and that learnings from one program are fully considered in all other programs.
• Establish highly collaborative and effective relationships with management colleagues in Clinical Research, Clinical Operations, Regulatory Affairs, Medical Writing, Quality, and other functions to ensure cross-functional alignment and team effectiveness.

Requirements and Qualifications:

• Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs, including regulatory strategy and leadership roles.
• Demonstrated success in leading regulatory submissions globally
• Direct experience with oncology drug development.
• Experienced in representing Regulatory on cross-functional teams and presenting to senior management. Excellent communicator.
• Excellent planning and organizational skills, and the ability to work simultaneously on multiple projects with tight timelines.

Preferred Qualifications:

• An advanced degree is desirable.
• Experience with combination studies, multiple expansion cohorts, basket or umbrella, and master protocols is highly preferred.
• Prior NDA experience is highly preferred.

Desired Skills and Experience

Regulatory Affairs, Regulatory Strategy, Oncology Drug Development, FDA Regulations, Health Authority Interactions, Clinical Research, Clinical Operations, Medical Writing, Quality Assurance, Cross-functional Leadership, Team Management, Mentoring, Regulatory Submissions, Global Regulatory Submissions, NDA Experience, Combination Studies, Expansion Cohorts, Basket Studies, Umbrella Studies, Master Protocols, Drug Development Strategy, Regulatory Policy Development, Pharmaceutical Industry, Biotech Industry, Life Sciences, Strategic Planning, Project Management, Senior Management Presentations, Stakeholder Management, Competitive Intelligence, Regulatory Compliance, Clinical Trial Design, Program Management, Risk Assessment, Regulatory Documentation, IND Submissions, BLA Submissions, Regulatory Intelligence, Health Authority Negotiations, Regulatory Guidelines, ICH Guidelines, Oncology Therapeutics, Drug Development Lifecycle, Regulatory Operations, Change Management, Process Improvement, Team Building, Performance Management, Resource Planning, Strategic Decision Making, Regulatory Affairs Leadership, Pharmaceutical Regulations, Clinical Development, Drug Approval Process

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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Associate/Senior Associate, Regulatory Affairs

Location: San Carlos, CA (Hybrid options available)

Industry: Clinical-stage Biopharmaceuticals

A leading clinical-stage biopharmaceutical company is seeking a talented Associate or Senior Associate in Regulatory Affairs to join their growing team. This organization is focused on developing innovative therapeutic antibodies for cancer, autoimmune, and other serious diseases, and offers an exciting opportunity to contribute to impactful drug development programs.

About the Opportunity:

You will play a key role in supporting global regulatory submissions and communications with health authorities, managing regulatory archives, coordinating with external eCTD publishing teams, and ensuring the smooth operation of day-to-day regulatory activities.

Key Responsibilities

• Collaborate with cross-functional teams to finalize high-quality, compliant regulatory submissions (eCTD format)
• Prepare and support routine submissions to health authorities under supervision
• Serve as regulatory document and submission support for assigned projects
• Coordinate with the Regulatory eCTD publishing team for document publishing and archival
• Manage regulatory submission trackers, archives, and commitment trackers
• Work with Quality and other departments to ensure data accuracy and integrity for submissions

Qualifications

• Bachelor's degree in a scientific field (advanced degree a plus)
• Minimum 2 years' experience in Regulatory Affairs within biotechnology/biopharmaceuticals
• Experience supporting regulatory submissions (INDs in the US, CTAs in Europe, Australia, Asia)
• Familiarity with ICH, CFR, and global health authority requirements
• Strong organizational and submission management skills
• Proficiency with Microsoft Office, Adobe, and eCTD software
• Excellent interpersonal skills and ability to work collaboratively