Senior Regulatory Affairs Manager – Pharmaceutical Division SARM
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Job Location:
Belmont, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
15-10-2025
Vacancies:
1 Vacancy
Job Summary
Job Title: Senior Regulatory Affairs Manager Pharmaceutical Division (Remote)
Location: Remote
Duration: 6 months
Position Summary:
We are seeking an experienced Senior Regulatory Affairs Manager to lead global regulatory operations information management and compliance initiatives in a pharmaceutical setting. The role involves overseeing regulatory information management (RIM) CMC compliance cross-functional projects and team leadership to ensure successful regulatory submissions and adherence to global standards.
Key Responsibilities:
Lead and manage global regulatory teams handling submission management regulatory information management and CMC compliance across multiple markets.
Oversee large-scale RIM implementations including data migration validation UAT and change management.
Manage regulatory projects such as marketing authorization transfers dossier updates and legal entity rationalization across regions.
Drive continuous improvement initiatives and process optimization using Lean Six Sigma methodologies.
Collaborate with cross-functional teams (CMC quality clinical legal) to ensure regulatory compliance and timely submissions.
Develop and maintain regulatory strategies aligned with global regulatory requirements and corporate goals.
Lead training and communications for regulatory systems processes and data standards.
Act as liaison between internal stakeholders clients and regulatory agencies for effective project execution.
Qualifications:
Minimum 10 years of regulatory affairs experience in the pharmaceutical industry with leadership responsibilities.
Proven expertise in regulatory information management systems (e.g. Veeva Vault Liquent Insight Global Submission Viewer) and submission lifecycle management.
Strong knowledge of CMC regulatory requirements dossier preparation and post-approval changes across global markets.
Experience managing large cross-functional global projects and teams.
Demonstrated success in data migration UAT and change management activities.
Familiarity with marketing authorization transfers legal entity rationalization and compliance programs.
Excellent project management strategic planning and business analysis skills.
Lean Six Sigma Green Belt preferred.
Strong technical writing communication and stakeholder management skills.
Bachelors degree in Life Sciences Pharmacy or related field; advanced degrees or regulatory certifications a plus.
Preferred Skills:
Experience working with top-tier pharmaceutical companies.
Knowledge of regulatory submission requirements for various dossier formats (centralized decentralized national).
Ability to operate in a matrix environment and lead cross-functional teams across geographies.
For more details reach at /
About Navitas Healthcare LLC certified WBENC and one of the fastest-growing healthcare staffing firms in the US providing Medical Clinical and Non-Clinical services to numerous hospitals. We offer the most competitive pay for every position we cater. We understand this is a partnership. You will not be blindsided and your salary will be discussed upfront.
Required Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
