Senior Regulatory Affairs Executive – Drug Registration
2 days ago
Summary
We are seeking a highly motivated and detail-oriented Senior Regulatory Affairs Executive to join our team. In this role, you will be responsible for managing the drug registration process for our innovative pharmaceuticals across Southeast Asia. You will work closely with regulatory agencies, internal stakeholders, and external partners to ensure timely and accurate submissions for marketing authorization approvals. You will also stay up-to-date on evolving regulatory requirements and proactively address potential issues to support product commercialization.
Responsibilities
- Regulatory Strategy: Develop and implement regulatory strategies to ensure timely approval of new products and maintenance of existing product licenses.
- Submission Management: Prepare, review, and submit regulatory documents to health authorities, including the Health Sciences Authority (HSA) in Singapore.
- Compliance: Ensure compliance with local and international regulatory requirements, guidelines, and standards.
- Liaison: Act as the primary point of contact with regulatory agencies, responding to queries and providing necessary documentation.
- Cross-Functional Collaboration: Work closely with R&D, Quality Assurance, and Marketing teams to ensure regulatory requirements are met throughout the product lifecycle.
- Regulatory Intelligence: Stay updated on regulatory changes and trends, and provide guidance to internal teams on potential impacts.
- Training: Provide training and support to junior regulatory staff and other departments on regulatory affairs processes and requirements.
Qualifications:
- Education: Bachelor's degree in Pharmacy, Life Sciences, or a related field. Advanced degree preferred.
- Experience: Minimum of 3 years of experience in regulatory affairs within the Pharmaceutical/Medical devics industry.
- Knowledge: In-depth knowledge of local and international regulatory requirements, including ICH guidelines and ASEAN regulations.
- Skills: Excellent communication, organizational, and project management skills. Ability to work independently and as part of a team.
- Attention to Detail: Strong attention to detail and ability to manage multiple projects simultaneously.
FDA
Regulatory Compliance
Ability To Work Independently
Quality Assurance
Interpersonal Skills
Regulatory Affairs
Oncology
Regulatory Strategy
Product Lifecycle Management
Clinical Trials
Compliance
Authorization
Medical Devices
Audits
Commercialization
Pharmacology
Regulatory Requirements
Life Sciences
Regulatory Submissions
Manufacturing
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