Job Title:
Regulatory Operations Senior Manager – Global
Job Summary:
A top pharmaceutical organization is hiring a Regulatory Operations Senior Manager to drive global regulatory submission strategies, CMC authoring, and ensure full compliance with FDA, EMA, and ICH guidelines. This senior-level role requires leadership in regulatory operations for both investigational and marketing applications across multiple regions, ensuring timely and quality regulatory filings.
Key Responsibilities:
Develop and implement novel regulatory strategies for drug development and global submissions.
Manage daily regulatory operations using project management tools and detailed project timelines.
Provide regulatory advice on critical development issues to internal stakeholders.
Review client programs and develop strategic plans covering clinical, analytical, and process development.
Ensure full compliance with ICH and country-specific regulatory requirements.
Author and oversee SOPs, workflows, and work instructions for regulatory operations including eCTD for IND/CTA/NDA/MAA submissions.
Lead CMC authoring and oversee the quality of regulatory documentation.
Collaborate closely with development teams on regulatory CMC and labeling strategies.
Serve as the key regulatory liaison with global health authorities.
Develop and execute EU market expansion strategies including DCP, CP, NP, and MRP submissions and EU QPPV setup.
Required Skills & Qualifications:
10–15 years of experience in a regulated life science environment.
Strong project management and organizational skills.
Excellent interpersonal and communication abilities.
Proven business development and strategic planning capabilities.
Expertise in FDA, HC, EMA, ICH guidelines, eCTD submission standards, dossier preparation (IND/CTA/NDA/MAA).
Experience with global (including RoW) regulatory markets preferred.
Familiarity with medical device regulations is a plus.
Knowledge of eCTD publishing systems, TRS toolbox, and regulatory information management tools.
Ability to manage regulatory operations priorities across multiple business areas.
Perks & Benefits:
Leadership role with high global visibility.
Opportunity to shape regulatory strategies for new drug development.
Work with cross-functional, international teams.
Professional growth in a global pharmaceutical environment.
Company Description:
A globally recognized pharmaceutical leader specializing in drug development, regulatory strategy, and life sciences innovation. Known for its commitment to quality, compliance, and excellence in global regulatory operations.
Work Mode:
Hybrid (On-site with flexibility for remote collaboration)
Call to Action:
Take the next step in your pharmaceutical regulatory career. Apply now to become a pivotal part of our global regulatory operations team.
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