Drug development process knowledge jobs

Medical Writer

Thermo Fisher Scientific · Posted Nov 10, 2026

Open

Remote, India
Remote
Full-time · Associate
2+ years

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Medical Writer

Thermo Fisher Scientific · Posted Nov 10, 2026

Open

Remote, India
Remote
Full-time · Associate
2+ years

Apply with Referso

Senior Manager, Regulatory Affairs

Sanofi · Posted Nov 9, 2026

Open

Hatsudai, Tokyo, Japan
On-site
Full-time · Manager
2+ years

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The Senior Manager, Regulatory Affairs serves as the Japan regulatory lead for assigned development projects. This role is responsible for formulating and executing Japan regulatory strategies in alignment with global development plans, leading PMDA interactions, and ensuring high‑quality regulatory submissions including CTNs, J-NDAs, and J-sNDAs.

Responsibilities

Develop and implement Japan regulatory strategies for development programs and new indications, ensuring alignment with global regulatory strategies.
Serve as the regulatory representative on project teams, providing expert guidance on Japan regulatory requirements.
Lead preparation and execution of PMDA Consultation Meetings and Health Authority interactions, including development of meeting scenarios and briefing documents.
Identify regulatory risks and develop mitigation plans; ensure timely communication and alignment across stakeholders.
Ensuring the timely communication and alignment across stakeholders.

Requirements

Bachelor’s degree or higher in a scientific or health-related field
Nice to have: Advanced degree in scientific or health-related field
Nice to have: CTD/eCTD preparation

Skills

CTN preparation PMDA consultations regulatory submissions

Associate Director, Corporate Strategy

Sarepta Therapeutics · Posted Nov 7, 2026

Open

Cambridge, Massachusetts, United States
Hybrid
Full-time · Director
$161K–$201K per year
7+ years

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The Associate Director, Corporate Strategy is an intense and important role helping Sarepta deliver on key corporate initiatives. The role will operate within our small internal consulting team that works through diverse projects representing Sarepta’s top priorities.

Compensation

$160,800 - $201,000 per year

Responsibilities

Coordinate Sarepta's annual strategic planning efforts with the Head of Corporate Strategy that translates to our overall long range plan and supports Finance through the annual budget planning process
Maintain an understanding of the overall portfolio competitive landscape assuring leaders are aware of current program status both inside and outside our portfolio
Collaborate with project lead to propose goals, scope, workstreams, analytical approach, success measures, required stakeholders, and roles and responsibilities for part of overall project
Collaborate with project lead to design and drive analysis to answer key questions, including sources, data analysis, and output format for presentation; ensure stakeholder buy-in; independently drive execution; double check and pressure test results to ensure no mistakes; develop integrated output presentation for part of overall project
Lead project management activities by scheduling and coordinating team meetings, setting objectives and agendas, documenting decisions and action items, identifying and monitoring risks, ensuring senior stakeholder alignment, and tracking progress against goals

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