Senior Regulatory Affairs Specialist

Responsibilities

Regulatory

• Drug product registration/ product variation applications.
• Follow up amendments related to MA license variation
• Monitor routinely pharmaceutical regulation and policy changes and assess impact for timely implementation and notice of other stakeholders
• Maintain / manage registration files and RA databases in shared drive of RA.
• Proof reading product package label against approved label and the labeling regulatory requirement.
• Communication with regulatory authorities and company headquarters.
• Submission of drug reimbursement application to HIRA or MoWH.
• Support drug reimbursement project.
• Promotional material (e.g., product brochure) review against regulations and product approved label.
• If required, answer/fulfill requests / queries originating from local authorities(MFDS, MOHW, KPIS, and HIRA etc.)

Pharmacovigilance

• Handling of drug safety related information and report it to HQ and local authority –Serious adverse events from studies and spontaneous adverse events occurred from products
• Report monthly reconciliation with MIS & Quality complaints
• Provide PV training to relevant stakeholders
• Fulfill the required tasks according to local & global procedure and regulations.
• Management of local PV SOPs
• Ensure a scientific and regulatory intelligence related to Pharmacovigilance.
• Learn HQ PV system & procedures and assess/ implement it to local SOPs & procedures.
•  Fulfill MFDS PV inspection
• To be registered to MFDS as PV responsible pharmacist.

Educations & Experiences

• Qualification of pharmacist in Bachelor or Higher degree.  

• 5-7 years’ experience in RA and/or PV in pharmaceutical company

Skills & Qualifications

• Proficient in MS Office, including Word, Excel and PowerPoint

• Effective communication and interpersonal skills

• Good verbal and writing English skill is preferred

• Knowledge of pharmaceutical regulations

Profile description:

Educations & Experiences

• Qualification of pharmacist in Bachelor or Higher degree.  
• 3-5 years’ experience in RA and/or PV in pharmaceutical company

Skills & Qualifications 

• Proficient in MS Office, including Word, Excel and PowerPoint
• Effective communication and interpersonal skills
• Good verbal and writing English skill is preferred
• Knowledge of pharmaceutical regulations

We offer:

Reasons to join us

Much more than a competitive salary, we offer continued personal development, we offer an interesting opportunity to join our global team and be part of our Global Technical Operations Leadership Team.

When you join Guerbet Group, you

• Are choosing the world’s leader in the technological sector of diagnostic and interventional imaging,
• Are joining our 2600 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life in more than 80 countries all over the world,
• Are joining a company where we value our diverse team coming from various horizons.

We # Achieve # Cooperate # Care # Innovate at Guerbet.