Regulatory Affairs Asst. Manager
6 days ago
Date Posted: March 7, 2018
Job Location: Paranaque City
Job Description:
• Planning, undertaking and overseeing product trials and regulatory inspections
- Keeping up-to-date with changes in regulatory legislation and guidelines
- Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- Review product promotional materials, labeling, storage, packaging, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
- Provide guidelines/ advice about regulations to manufacturers and scientists
Qualifications:
• Graduate of any Science/ Medical Course preferably in Pharmacy or Biochemistry
- Must have at least 5 years relevant work experience
- Minimum 2 years solid work experience as a Regulatory Affairs Officer/ Supervisor
- Must have the ability to grasp new concepts quickly and to assimilate and evaluate scientific data
- Strong analytical and problem-solving skills
- Ability to work under pressure and adhere to strict deadlines
- Team-working skills and the ability to lead and motivate others
- In-depth knowledge in regulatory requirements, procedures and policies
- Must have excellent communication skills (must be well-versed in both English & Filipino)
- Excellent active listening, negotiation and presentation skills
*Only shortlisted candidates will be notified.
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