Regulatory Operations Senior Manager

10+ years

Not Disclosed

Princeton Junction

10 July 26, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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

Job Description: Senior Manager of Regulatory Operations

We are seeking a Senior Manager of Regulatory Operations to lead and innovate within our regulatory affairs team. This role is pivotal in shaping and executing regulatory strategies for novel drugs, managing day-to-day operations, and ensuring compliance with global regulatory standards.

Core Responsibilities:

Regulatory Strategy Development:
- Strategic Planning: Develop and implement novel drug regulatory strategies.
- Regulatory Advice: Provide sound regulatory advice on key development issues and communicate strategies to stakeholders.
Operational Management:
- Project Management: Oversee daily operations using project management tools, creating and maintaining detailed project timelines.
- Compliance: Ensure development programs comply with ICH and local regulatory requirements.
Documentation and Compliance:
- SOPs and Workflows: Initiate, author, and collaborate on SOPs, work instructions, and workflows for regulatory operations (e.g., eCTD submissions, Investigational and Marketing Applications).
- Document Authoring: Author clear and concise regulatory documents (CMC authoring) with oversight for regulatory submissions and messaging.
Strategic Alignment:
- Development Coordination: Collaborate with development teams to align regulatory strategy, CMC strategy, and labeling strategy for Pharmaceutical/Biological products.
- Regulatory Liaison: Serve as the primary point of contact between the company and regulatory agencies.
EU Expansion Strategy:
- MAA Planning: Strategize and plan for EU expansion, including MAA submissions (DCP, CP, NP, MRP), and setting up EU QPPV Office.

Desirable Skills and Experience:

Experience: 10–15 years in a regulated life science environment with a focus on regulatory operations.
Project Management: Strong skills in project management, planning, and execution.
Interpersonal Skills: Excellent communication and interpersonal skills.
Business Development: Experience in organizational strategy, process management, KPIs, metrics, and resource forecasting.
Regulatory Knowledge: Extensive knowledge of global submission standards (FDA, HC, EMA, ICH, eCTD), regulatory change management, and operations.
Market Knowledge: Familiarity with RoW markets is a plus; experience in medical device regulations is advantageous.
eCTD Systems: Knowledge of eCTD publishing systems, TRS toolbox, and related tools.
Regulatory Information Management: Strong understanding of regulatory information management concepts and tools for prioritizing regulatory operations.

This role is designed for a strategic leader with substantial experience in regulatory affairs, project management, and compliance, capable of driving regulatory strategy and operations across global markets.

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Regulatory Operations Senior Manager

Job Description

Core Responsibilities:

Desirable Skills and Experience:

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