Product Registration Specialist
freeC's Client

Lưu việc
Nhắn tin
Toàn thời gian
Tuyển 1 người
3 năm kinh nghiệm
Hồ Chí Minh
Đăng tuyển ngày 28/10/2024

Mô tả công việc

Key Responsibilities:


Regulatory Submission and Compliance

Prepare and compile registration dossiers in line with regulatory guidelines for submission to local and international regulatory agencies.

Ensure timely submission of all required documentation for product approval, renewal, and compliance.

Monitor the regulatory status of products, ensuring compliance throughout the product lifecycle, and implement any necessary updates to maintain market access.


Documentation and Record Management

Maintain up-to-date records and databases of product registration and compliance documentation.

Ensure that all documents meet internal quality standards and are aligned with regulatory requirements.

Assist in managing regulatory documentation changes, including variations and amendments, in accordance with regulatory guidelines.


Regulatory Intelligence and Strategy

Stay informed on regulatory changes, updates, and trends affecting product registration in target markets.

Assist in the development of regulatory strategies to support the registration of new products, product extensions, and renewals.

Provide recommendations to management regarding regulatory pathways, potential risks, and strategies to mitigate them.


Cross-functional Collaboration

Work closely with internal teams, including quality assurance, production, and R&D, to gather the required documentation and ensure regulatory requirements are met.

Liaise with regulatory authorities and external consultants to facilitate the product registration process.

Support product launches by ensuring regulatory approvals are obtained within the required timelines.


Qualifications:

Education: Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, or a related field; a Master’s degree or additional regulatory certification is a plus.

Experience:

Minimum of 3-5 years of experience in regulatory affairs, with a focus on product registration within the pharmaceutical industry.

Experience with regulatory submission processes for local and/or international markets.

Skills and Competencies:

Strong understanding of regulatory requirements, especially related to pharmaceuticals.

Excellent organizational, analytical, and communication skills.

Detail-oriented with the ability to manage multiple projects and deadlines.

Proficiency in regulatory submission software and MS Office.

Kỹ năng

Production

Ngành nghề

Giới thiệu về công ty
freeC's Client
Hồ Chí Minh
101-300 nhân viên
https://freec.asia/
Hồ Chí Minh
101-300 nhân viên
https://freec.asia/
HRTech
IT/ Web

Giới thiệu

freeC is the Smart Recruiting Platform that leverages matching technology to actively connect hundred of thousand of employers and job seekers. The success of freeC is determined by our success in operating as a unified team. If you're interesting, ambitious, and eager to advance your career with us, explore our vacancies as below. We're excited to have you on board our ship to help us grow fast, deliver on our mission of actively connecting employers and job seekers around Vietnam

Địa chỉ

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