Job Summary
Are you a go getter, enthusiastic, focused, result oriented and target driven? If these few words describe you, our client a leading Pharmaceutical manufacturing company is looking for you. Our Client Seeks to recruit a Pharmacist Regulatory Affairs to ensure compliance to regulatory requirements and ensure timely product registration.
Minimum Qualification:Bachelor
Experience Level:Mid level
Experience Length:4 years
Job Description
REPORTING TO: DIRECTOR OPERATIONS.
Duties and Responsibilities.
1. Ensure all the required licenses are available and valid.
2. Preparing of high-quality dossiers for new product registration and the same to be done and submitted on timely manner.
3. Ensure to respond to queries in time and no repeat queries to follow.
4. Notify respective country RA and other organizations on quality issues which may have been detected by Quality Aassurance or other organizations.
5. Ensure the annual retention certificates are done on time.
6. Adequately prepare and participate in both internal and external Audits.
7. Ensuring the correct translation and comprehensibility of technical texts shown on the packaging and package inserts of medicines.
8. Ensure availability of information from other sections for dossier preparation and response to queries.
9. Develop train and guide the RA team members on the various processes and procedures in Regulatory affairs.
10. Be aware of the current and emerging Regulatory Affairs regulations and ensure compliance of the same.
QUALIFICATIONS
1. Bachelor’s degree in pharmacy.
2. At least 4 years of experience in similar position.
Interested candidates are advised to submit their applications which shall include an application letter and curriculum vitae. These must be received by15/05/2020.Only shortlisted candidates will be contacted.
REPORTING TO: DIRECTOR OPERATIONS.
Duties and Responsibilities.
1. Ensure all the required licenses are available and valid.
2. Preparing of high-quality dossiers for new product registration and the same to be done and submitted on timely manner.
3. Ensure to respond to queries in time and no repeat queries to follow.
4. Notify respective country RA and other organizations on quality issues which may have been detected by Quality Aassurance or other organizations.
5. Ensure the annual retention certificates are done on time.
6. Adequately prepare and participate in both internal and external Audits.
7. Ensuring the correct translation and comprehensibility of technical texts shown on the packaging and package inserts of medicines.
8. Ensure availability of information from other sections for dossier preparation and response to queries.
9. Develop train and guide the RA team members on the various processes and procedures in Regulatory affairs.
10. Be aware of the current and emerging Regulatory Affairs regulations and ensure compliance of the same.
QUALIFICATIONS
1. Bachelor’s degree in pharmacy.
2. At least 4 years of experience in similar position.
Interested candidates are advised to submit their applications which shall include an application letter and curriculum vitae. These must be received by15/05/2020.Only shortlisted candidates will be contacted.
