Senior Associate/Strategist – Regulatory Affairs (APAC CMC) — ClinChoice | joboostr

Přeskočit na hlavní obsah

Senior Associate/Strategist – Regulatory Affairs (APAC CMC) — ClinChoice | joboostr

5 979 nabídek nalezeno

Chytré hledání

Merchandiser Opava a Krnov

beeline Group

Česko, Opava, Krnov

od 182 Kč / hodina

Dnes

Team Lead, Learning and Development (Contract, Remote)

INFUSE

Remote

Dnes

Events Preparation Trainee

2N TELEKOMUNIKACE

Česko, Praha

Dnes

Lead Projector Engineer (Novy Jicin, CZ)

OP Mobility

Česko, Nový Jičín

Dnes

Vedoucí oddělení (ž/m)

Kaufland

Česko, Beroun

49 000 Kč – 55 000 Kč / měsíc

Dnes

Manažer prodejny (ž/m)

Kaufland

Česko, Kladno

Dnes

Principal Procurement Manager

Vertice

Česko, Brno

Dnes

Nepali-English Interpreter

Homeland Language Services

Remote

Dnes

Advanced Packaging & Power Delivery Senior Engineer

Axelera AI

NizozemskoRemote

Dnes

Lifecycle Specialist: Time & Attendance

Remote

Remote

29 750 US$ – 67 000 US$ / rok

Dnes

Senior Talent Acquisition Partner - APAC

Zimmer Biomet

Remote

Dnes

Senior Android Engineer - Remote

Replika

ČeskoRemote

Dnes

Paralegal

FTMO

Česko, Praha

Dnes

Senior Research Engineer (Code World Models)

JetBrains

Česko, Praha

Dnes

Junior Lawyer

FTMO

Česko, Praha

Dnes

AI Technical Lead - C++ Ecosystem

JetBrains

Česko, Praha

Dnes

Sales Manager

Wolt

Česko, Praha

Dnes

Lifecycle Specialist, Employee Relations and Transitions - EMEA

Remote

Remote

37 250 US$ – 83 800 US$ / rok

Dnes

Principal Engineer

Vilgain

Česko, Praha

Dnes

Senior Data Engineer

Ciklum

PolskoRemote

Dnes

C# Developer (Veeam Backup for Hypervisors)

Veeam

Remote

Dnes

Marketing Analytics Specialist

Tameson

ČeskoRemote

Dnes

Product Marketing Manager (Integrations)

Apify Technologies

Česko, Praha

Dnes

💎

Cloud Security Analyst

Cloudbeds

ČeskoRemote

Dnes

Senior Product Manager

Emplifi

Česko, Praha

Dnes

Lead Backend Engineer - Piktochart

Piktochart

Latinskoamerická oblastRemote

Dnes

Performance QA Engineer

Veeam

Česko, Praha

Dnes

BE Operator Lead

Ball

Česko, Plzeň

od 42 000 Kč / měsíc

Dnes

Quality Manager

Ball

Česko, Ejpovice

1 050 000 Kč – 1 512 000 Kč / rok

Dnes

Referent nabídkového oddělení

Jeld-Wen

Česko, Humpolec

Dnes

Senior Associate/Strategist – Regulatory Affairs (APAC CMC)

ClinChoice

Českopřed 5 dny

Mám zájem Přizpůsobit životopis

Co budeš dělat

Authoring regulatory submissions : Writing and reviewing the CMC sections for new e.g. New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs) and lifecycle maintenance regulatory filings including responses to Health Authority’s questions.
Ensuring regulatory compliance : Making sure that all documents align with the requirements of regulatory bodies as well as International Council for Harmonisation (ICH) guidelines.
Collaborating with subject matter experts (SMEs) : Working closely with scientists, quality assurance (QA), manufacturing teams, and regulatory affairs colleagues to gather accurate and complete information about a drug's composition, manufacturing process, and quality control.
Maintaining document quality : Ensuring completion of high-quality documents i.e. clear, concise, scientifically accurate, and consistent in style and format, complying with regulatory guidelines and internal processes within timelines.
Managing timelines : Adhering to strict project schedules to ensure timely completion of submissions.
Identify, Assess and Communicate potential CMC Regulatory issues and propose mitigation strategies .
Understands, interprets and guides teams on regulations and policies related to manufacture and control of medicinal products to expedite the submission, review and obtain approvals.

Koho hledáme

Educational background : A bachelor's degree or higher in a scientific field, such as Chemistry, Pharmaceutical Sciences, or a related discipline.
Experience : Minimum of 5 ~ 9 years of relevant work experience working within a Regulatory Affairs Department with direct accountability for deliverables.
Pharmaceutical experience : Prior experience authoring CMC sections for regulatory submissions is a standard requirement.
Technical writing expertise : Exceptional technical writing, editing, and communication skills are required to translate complex scientific data into clear regulatory documentation.
Regulatory knowledge : A strong knowledge of CMC regulatory requirements for multiple global regions (e.g., APAC, U.S., EU) is essential. Experience with the electronic Common Technical Document (eCTD) format is also crucial.
Industry familiarity : A background in pharmaceutical manufacturing or quality control is often beneficial.
Collaboration and project management : The ability to work independently, manage projects, and communicate effectively with cross-functional teams is critical.
Detail-oriented : Meticulous attention to detail is necessary to ensure the accuracy and completeness of submissions.

Senior