Sr. Director, Regulatory Affairs Strategy

10+ years

Not Disclosed

Princeton Junction

10 Nov. 28, 2024

Job Description

Job Type: Full Time Education: MSc./M. Pharm/PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Senior Director, Global Regulatory Affairs Strategy
Company: [Company Name]

Position Overview

The Senior Director, Global Regulatory Affairs Strategy will provide strategic leadership for regulatory affairs across novel drug development programs. This role is responsible for developing and executing comprehensive regulatory strategies for each program, ensuring compliance with ICH regulatory requirements, interacting with regulatory agencies, and overseeing all regulatory filings.

Key Responsibilities

Regulatory Strategy Development

Lead the development and execution of regulatory strategies for novel drug development programs, ensuring alignment with both ICH and local regulatory requirements.
Develop the registration pathway for each program and manage the regulatory strategy through all phases of development.
Collaborate with internal teams to ensure strategies support development milestones and product lifecycle management.

Regulatory Submissions

Author and oversee the preparation of regulatory documents for submissions, including INDs, IMPDs, NDAs, BLAs, and briefing books.
Ensure the content, messaging, and regulatory compliance of all submission materials.
Interact with regulatory agencies on behalf of the company to facilitate regulatory approvals and respond to agency inquiries.

Collaboration and Communication

Work closely with the Regulatory CMC Lead and the overall development team to ensure alignment between regulatory strategies and the chemistry, manufacturing, and controls (CMC) strategy.
Serve as the primary point of contact for regulatory agencies, acting as the regulatory liaison between the company and regulatory bodies.
Foster strong cross-functional collaboration, managing relationships with internal stakeholders and external regulatory authorities.

Project Management

Manage complex regulatory programs and ensure the timely and efficient execution of regulatory activities.
Apply strong project management skills to coordinate and track progress across multiple teams and programs.

Qualifications

Education & Experience

Master’s degree in Chemistry, Biochemistry, Pharmacy, Biomedical Engineering, or Chemical Engineering is required.
PhD or PharmD in one of the above disciplines is preferred.
10+ years of industry experience in regulatory affairs, with a focus on novel drug development.
Experience in CMC (Chemistry, Manufacturing, and Controls) and/or Botanical regulatory affairs is a plus.
RAC (Regulatory Affairs Certification) is preferred.

Skills & Knowledge

In-depth understanding of ICH guidelines and US CFR (Code of Federal Regulations) requirements.
Extensive experience in preparing and authoring regulatory submissions, including INDs, IMPDs, NDAs, BLAs, and briefing books.
Proven experience in direct interaction with regulatory agencies.
Strong communication skills—both verbal and written—allowing clear and effective interaction with internal teams and regulatory authorities.

Apply Today!

If you are an experienced regulatory affairs professional with a passion for novel drug development and regulatory strategy, we invite you to apply for the Senior Director, Global Regulatory Affairs Strategy position at [Company Name]. Lead impactful regulatory strategies that support the development of innovative therapies.

Note: Be sure to tailor the company name and application process details for your specific organization.

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