Senior Regulatory Affairs Manager - Pharmaceutical Division - SARM

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.

• Bachelor’s 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 [email protected]/516-862-1203

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.