Global CTA Submissions Lead & Regulatory Strategy

one stop engineering pte. ltd.

Singapore

In loco

SGD 120.000 - 180.000

Tempo pieno

7 giorni fa

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Descrizione del lavoro

one stop engineering pte. ltd. is seeking an experienced CTA regulatory submissions professional to manage a portfolio of CTAs, ensure timely submissions, and provide strategic guidance on country requirements.

You will train and advise cross-functional teams, lead CTR-related processes, and maintain high-quality regulatory documentation. The role requires a Bachelor’s degree in life sciences with 6–7 years CTA experience, strong IT skills, and excellent communication in English.

Competenze

Bachelor's degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences.
6–7 years CTA experience, preferably in global clinical trial submissions to regulatory agencies.
Proficient IT skills: MS Word, Excel, PowerPoint, Adobe Acrobat and global databases.

Mansioni

Manage a portfolio of CTAs including preparation and distribution of documentation for new CTAs and maintenance activities.
Provide advice on submission strategy and country requirements for regulatory submissions.
Act as SME on EU CTR submissions, guiding cross functional teams and defining submission strategies.