Job Description

WE ARE HIRING FOR MNC!

Job Details:

Position : ASEAN Regulatory Affairs Consultant

Company Industry : Pharmaceutical

Working Hours : Mon - Fri (8:30AM - 5:30PM) | Night calls when needed

Working Mode: Hybrid (WFO 2 to 3 times a week)

Working Location : Axiata Tower, 27th Floor, Jalan Stesen Sentral 5, 50470 Kuala Lumpur. Malaysia

Working Duration: 12 months contract with PERSOLKELLY

Remuneration : Salary RM3,500 - RM5,000 (based on qualification & education), statutory contribution & leave entitlement

Bonus: 1 Month Bonus once completed contract

WHO CAN APPLY?

• Bachelor\'s Degree in a related field such as Pharmacy, Pharmaceutical Science, Regulatory Affairs, Science, Biomedical Science, Biology, Chemistry, Legal Studies, Law, Nursing, Physician Assistance etc.
• 1 to 2 years experience with good knowledge of ASEAN pharmaceutical drug registration requirements
• Experience in RA of pharmaceutical products and in communicating directly with regulatory authorities, preferably with experience in ASEAN regulations
• Strong analytical skills
• Excellent in verbal, written communication and presentation skills
• Ability to evaluate, plan and prioritize regulatory submissions
• Knowledge & experience in conducting scientific, regulatory intelligence, legal, or business research
• Prior experience using spreadsheet and presentation software
• Familiar with continuous improvement methodologies such as Lean
• Familiar with using regulatory systems such as Artwork Management system and Veeva (or similar).

KEY RESPONSIBILITIES

• Work closely with ASEAN RA Team
• To ensure regulatory compliance for Pharmaceutical Diagnostics (PDx)in the ASEAN region
• To ensure that local RA activities reflect and support both local commercial and global business priorities
• To drive the development and strengthening of relationships with regulatory authorities and to act as liaison with external regulatory bodies, as required, to ensure appropriate input into regulatory strategy and obtain rapid application approvals
• To provide proactive regulatory advice and expertise to other groups
• To manage the local regulatory activities including;

• Support to central RA (CRA) for new drug registrations and product lifecycle RA maintenance activities
• Support to local commercia on strategic and operational issues (promotional material,etc)
• Support to central Pharmacovigilance in safety issues and adverse event reporting when needed
• To manage recruitment, development, training and activities of internal RA personnel, contractors and consultants - (in case there are direct line reports to this position)
• Manage RA Budget
• Conduct RA audits when necessary
• To represent company\'s regulatory function outside the company (local authorities, congresses and trade associations etc)
• To ensure consistent and quality regulatory practices and procedures which are in line with the rest of national RA and meet the needs of CRA
• To continuously review and put strategies in place to improve existing processes.

Serious applicants can send your updated resume to Fadzliah_Fabli@persolkelly.com

- Subject: Job application for ASEAN Regulatory Affairs Consultant

- Please also provide your expected salary and notice period

Due to high number of applicants, only qualified candidates will be contacted for interview.

We thank you for your application \xf0\x9f\x98\x8a.

Reference Number:

Contact Details:

Fadzliah_Fabli@persolkelly.com

Profession:

Healthcare & Pharmaceutical
Pharmaceutical

Company:

PERSOLKELLY_RHQ

Date Posted:

22/08/2023 7:52:00 PM

PersolKelly