Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals

Health Care

251-1K (427)

Founded 2012

145 open positions

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Regulatory Manager / Senior Regulatory Manager

2 hours, 51 minutes ago

Serbia

Full-time

Senior

Compliance Manager

Legal

Apply Now

Precision Medicine Group

Pharmaceuticals

251-1K

Founded 2012

View All Jobs 145

Description

Provide regulatory strategy and development guidance across the clinical trial lifecycle.
Prepare, compile, coordinate, and review regulatory submissions for Regulatory Authorities and Ethics Committees.
Manage CTA/INDs, annual reports, amendments, scientific advice meetings, orphan designations, paediatric planning, and marketing applications.
Develop or review submission documents to ensure compliance with applicable regulatory standards.
Represent Global Regulatory Affairs in project team and business development meetings with internal and external stakeholders.
Lead regional or global project efforts when needed and coordinate Regulatory Affairs Specialists to meet submission targets.
Maintain project plans, trackers, and regulatory intelligence tools and keep Regulatory Leadership informed.
Support development of Regulatory Affairs Specialists and other operational staff.
Contribute to regulatory strategy and timeline development for new study opportunities.
Provide ICH GCP guidance, advice, and training to internal and external clients.

Requirements

Bachelor’s degree or equivalent experience, ideally in a scientific or healthcare discipline.
5 years of regulatory experience for Manager level or 7 years for Senior Manager level.
Regulatory affairs experience working for a Clinical Research Organisation.
Experience leading clinical submissions.
In-depth knowledge of the drug development process, including regulatory milestones.
Specialized knowledge of regulatory activities in at least one major region, such as the EU or US.
Experience with submissions to Regulatory Authorities, including INDs/CTAs, amendments, scientific advice procedures, and post-approval submissions.
Ability to understand clinical and pre-clinical study results and interpret them for regulatory strategy.
Working knowledge of clinical trial methodology, protocols, and indications being studied.
Computer literacy with MS Office/Office 365 and fluency in English.
Graduate or postgraduate education preferred.
Basic understanding of financial management preferred.
Availability for domestic and international travel, including overnight stays.

Benefits

Remote work is available, with the role marked as #LI-Remote.
Opportunity to work on groundbreaking cancer therapies in oncology and rare disease.
Employee ideas are valued and encouraged to drive positive change.
Equal Opportunity Employer status with non-discriminatory hiring practices.
Reasonable accommodation support for applicants with disabilities.

Interested in this position?

Apply directly on the company website

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