Regulatory Manager – Senior Regulatory Manager

Precision Medicine Group

. Provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures .

Posted 9/21/2026full-timeRemote • SerbiaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory strategy and development for clinical trials, ensuring compliance with applicable regulations and timely submissions to Regulatory Authorities. Possesses strong leadership skills to manage teams and projects while maintaining high-quality standards in regulatory documentation.

Highest-signal resume keywords

Regulatory Strategy DevelopmentClinical Trial SubmissionsRegulatory Affairs ExperienceKnowledge of Drug Development ProcessICH GCP Guidance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsCTA/IND ApplicationsScientific Advice ProceduresRegulatory MilestonesClinical Trials MethodologyRegulatory Intelligence ToolsDocument ReviewRegulatory ComplianceData CollectionFinancial Management

Soft Skills

Interpersonal SkillsTeam CollaborationProblem SolvingEffective CommunicationIndependent Planning

Tools & Technologies

Regulatory Tracking SystemsProject Management ToolsQuality Management Systems

Industry Keywords

Pharmaceutical IndustryCRO ExperienceOrphan DesignationsPaediatric PlanningRegulatory Authority Meetings

About the role

Key responsibilities & impact

Provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures
Ensure timely preparation of organized, quality regulatory submissions in compliance with applicable regulations
Coordinate and prepare regulatory documents for submission to Regulatory Authorities and/or Ethics Committees
Provide regulatory guidance throughout the clinical development life cycle
Compile, coordinate, and review CTA/IND applications, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications
Develop and review documents for Regulatory Authorities and Ethics Committees
Represent Global Regulatory Affairs at project team and business development meetings with internal and external customers
Work within project teams and lead regional or global projects when necessary
Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets
Maintain project plans, trackers, and regulatory intelligence tools; update Regulatory Leadership
Assist in developing Regulatory Affairs Specialists and other operational staff
Provide input into regulatory strategy and timeline development for new study opportunities
Assist in establishing company standards for high-quality submitted information
Participate in corporate quality initiatives across Clinical Solutions business units
Maintain and expand knowledge of laws, regulations, and guidelines governing drug development and approval
Provide ICH GCP guidance, advice, and training to internal and external clients

Requirements

What you’ll need

Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline
5 years Regulatory experience required for the Manager level and 7 years Regulatory experience required for the Senior Manager Regulatory level
Informed knowledge of all aspects of the drug development process, including regulatory milestones
Specialized knowledge of regulatory activities for at least one major region (EU, US)
Experience with submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions
Regulatory affairs experience working for a CRO or within the Pharmaceutical Industry
Experience leading Clinical Submissions
Ability to understand clinical and pre-clinical study results and interpret them for regulatory positions and strategy
Knowledge of clinical trials methodology, including working knowledge of protocols and indications being studied
Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development
Availability for domestic and international travel, including overnight stays
Strong interpersonal skills and ability to contribute to a team environment
Understanding of financial management
Ability to manage multiple and varied tasks in a fast-moving environment
Good record-keeping skills
Ability to work and plan independently and in a team environment
Ability to resolve project-related problems and prioritize workload to meet deadlines with little management support
Ability to collect data of consistently high standard
Effective verbal and written communication in English
High proficiency conducting formal presentations to colleagues, investigative staff, and clients

Benefits

Comp & perks

Employees feel appreciated for their contributions
Employee ideas are valued and nurtured
Equal opportunity employment
Reasonable accommodation support for applicants with disabilities