
Regulatory Pharmacist
2 days ago
Job Description
- Serves as a point of contact and coordinates with regulatory authorities, local and international clients regarding the preparation of documents for product registrations, renewals, compliances, variations and other regulatory matters.
- Review, and submit regulatory dossiers (e.g., CTD, eCTD, ACTD) and requirements to regulatory agencies for new product registrations, renewals, compliances and variations.
- Ensure timely approvals and renewals by communication to regulatory authorities relative to company and product registrations, follow ups and compliances.
- Responsible for preparing the necessary documents for applying GMP clearance of manufacturers to local regulatory authority.
- Maintain product registration files and regulatory databases.
- Interpret and ensure up-to-date compliance of regulatory requirements, guidelines, and legislation (WHO, ICH, FDA, EMA, MHRA and local health authorities)
- Ensure compliance of product labeling, packaging, and advertising with regulatory standards.
- Ensure pharmacovigilance compliance according to regulatory requirements.
- Provide regulatory guidance to support strategic business and product decisions.
- Responsible for the application, renewal and filing of Trademark of products with IPO
Qualifications:
- Candidate must possess a Bachelor's/College Degree in Pharmacy
- Must have a valid PRC ID for Pharmacist
- Must be able to multitask and work under pressure
- Must possess good communication and organization skills
- Must be able to communicate well in English
- Goal-driven, self-motivated and with high sense of responsibility, commitment and integrity
- Required Skills: MS Excel, MS Word, Powerpoint, Adobe Illustrator
We offer:
- Most favorable working conditions
- Highest incentive system extra salary
- Experience overseas business trip to Korea
- Experience for various educations and seminars
Working Hours:
- Monday-Thursday: 8:00 AM to 5:00 PM
- Wednesday: Work From Home (WFH)
- Friday: 8:00 AM to 4:00 PM
Job Types: Full-time, Permanent
Pay: Php25, Php60,000.00 per month
Benefits:
- Company Christmas gift
- Health insurance
- Paid training
- Work from home
Work Location: In person
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