About Cristcot

We are in the business of addressing the problem within the problem. We focus on the details and connections that other, major pharma companies have left ignored for years. There are better ways, better drugs and better formulations and we will make them a reality by analyzing, understanding and solving the problems within the problems.

Job Summary:

The Senior Director of Regulatory Affairs will support Cristcot in its growth by supporting all regulatory needs across the company.  This role will lead global regulatory submission management, publishing, and archiving for pharmaceutical and drug-device combination products and also serve as the Regulatory Affairs Lead and subject matter expert for FDA regulated advertising and promotional materials, ensuring compliance while enabling business strategy across products and therapeutic areas. This leadership role will ensure compliant, efficient, and timely submissions to global health authorities (FDA, EMA, MHRA, etc.) across all phases of development and post-approval.  

Primary Relationships:

• The role will partner with marketing, legal, medical and compliance to drive the Promotional Review Committee (PRC) to ensure regulatory compliance with U.S. regulations.  
• Within Cristcot, the Senior Director of Regulatory Affairs will partner with Clinical, Manufacturing, Quality, to ensure submission-readiness and alignment with regulatory timelines, including the review of all product related changes for regulatory impact 
• Outside Cristcot, the Senior Director of Regulatory Affairs will work closely with outside vendors, including but not limited to technical and clinical writing and external publishers. This position will also communicate and coordinate with the FDA. 

Primary Job Responsibilities:

The Senior Director of Regulatory Affairs will have in-depth knowledge of regulatory systems, global eCTD standards, and experience managing submissions, tracking information and timely correspondence within a highly regulated industry.  The Senior Director of Regulatory Affairs will oversee the planning, compilation, publishing, QC, and electronic submission of regulatory documents (eCTD/CTD/NEES) for INDs, NDAs, BLAs, MAAs, amendments, supplements, and annual reports. 

The Activities of the Senior Director of Regulatory Affairs:

FDA Promotional Review & Submission Ownership

• Regulatory review and approval of:
• • HCP and DTC promotional materials
  • Digital, social, sales aids, congress material
  • Disease awareness & corporate communications
• Ownership or oversight of FDA Form 2253 submissions, ensuring alignment to:
• • FDA regulations
  • OPDP/APLB guidance
  • Product labeling and PI

MLR / PRC Governance & Leadership

• Acts as Regulatory Lead in MLR/PMRC/CMRP forums
• Chairs or cochairs high volume promotional review meetings
• Resolves conflicts, escalates risk issues, and enables alignment
• Ensures consistency across brands and therapeutic areas

Strategic Commercial Enablement

• Advises Commercial, Marketing, and Medical on:
• • Claim substantiation
  • Launch strategy
  • Campaign risk mitigation
• Partners early in campaign development (not just review)
• Translate evolving FDA guidance into actionable strategy

FDA / OPDP Interface & Negotiation

• Primary point-of-contact with FDA OPDP and the Advertising & Promotional Labeling Branch (APLB)
• Manages:
• • Advisory comments
  • Information requests
  • Untitled / Warning letter responses
  • OPDP negotiations when needed

People & Matrix Leadership

• Strong matrix leadership across Medical, Legal, Commercial, Compliance
• Mentoring, training, and capability building

Process Ownership & Policy Development

• Develops:
• • Departmental (regulatory owned) SOPs and Work Instructions 
  • Promotional review frameworks
  • Ensures inspection readiness and audit support

CMC Representation

• Serves as regulatory CMC representative, develops and plans regulatory CMC submission strategy
• Coordinates and manages CMC regulatory submissions, applying CMC regulatory strategies
• Prepare briefing books for Health Authority meetings
• Establish and maintain sound working relationships with partners and customers
• Keep knowledge up to date with regard to regulatory guidelines and requirements as well as new technical trends

Regulatory Strategy

• Develop and execute comprehensive regulatory strategies that support product development, approval, and commercialization while aligning with the company's strategic objectives

Regulatory Compliance

• Stay abreast of evolving regulations, guidelines, and industry best practices
• Ensure that the company's activities and products adhere to all applicable regulatory requirements
• Lead Review in PRC Process and advise cross-functional teams on potential issues and updates to codes or guidelines
• Lead Regulatory Review in PRC Process and provide guidance and strategy. Manage FDA submissions and tracking for compliance

Submission Management

• Oversee the preparation, review, and submission of regulatory documents, including but not limited to Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs)

Cross-Functional Collaboration

• Collaborate closely with R&D, Quality Assurance, Clinical Development, and other teams to provide regulatory guidance and ensure the seamless integration of regulatory considerations into the product development process

Quality Assurance

• Supervise regulatory aspects of quality systems, including compliance with Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), and Good Laboratory Practices.
• Partner with Quality to assess all GxP-related process change controls for regulatory impact.  
• Partner with Quality to capture all necessary reports as part of post-approval submissions. 

Risk Assessment

• Identify and assess regulatory risks associated with projects and proactively propose solutions to mitigate these risks.
• Designs and implements regulatory strategies to obtain, maintain product investigative and marketing applications, and extend product registrations.
• Provides proactive guidance to internal groups based on technical and regulatory knowledge towards development of strategic and tactical plans. Identifies and assesses regulatory risks associated with product development of the company’s drug assets.
• Represents the Regulatory function on asset development teams
• Leads the development of strategic plans and tactical implementation resulting in the creation and submission of Regulatory documents, e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings.

Skills and Qualifications:

• Bachelor’s degree in Life Sciences required
• PharmD, PhD, MS, JD, or MBA preferred
• 15+ years of Regulatory Operations experience in the pharmaceutical, biotech, or medical device industry.
• 5+ years specifically in FDA Advertising & Promotion
• Launch and lifecycle experience strongly valued
• Proven track record in planning, managing, and submitting global eCTD regulatory dossiers
• Deep knowledge of applicable regulations (FDA- Parts 11, 211, 820), ISO, EMA, ICH, Health Canada, MHRA) and industry best practices 
• Hands-on experience with eCTD publishing tools and EDMS platforms (e.g., Veeva Vault RIM, Lorenz docuBridge, Extedo, etc.)
• Proven track record to successfully work in interdisciplinary teams, planning and coordinating
• Effective planning, organizational and interpersonal skills 
• Good technical writing skills
• Strong organizational, analytical, and leadership skills
• Experience with combination products or devices regulated under both FDA/CDER and CDRH
• Experience with complex regulatory project management
• Familiarity with SPL submissions, XEVMPD, and IDMP initiatives
• Knowledge of RIM implementation and structured content authoring systems
• Ability to travel up to 20%