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RA Manager (Medical Device/Pharma)

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Our client is seeking a dedicated and experienced Regulatory Affairs (RA) Manager.This role is perfect for someone with a background in pharmacy, who has honed their skills in the pharmaceutical and medical device industrial field. The successful candidate will have a proven track record of people management and will be comfortable providing extended support to Pharmacovigilance (PV),Materiovigilance,Quality incidence management, New Business Development (NBD) and advertisement management

Regulatory Affairs Manager

  • Bachelor’s degree in pharmacy required.
  • 8+ years experience in pharma and medical device industrial field
  • Strong English communication skills

What you'll do:

As an RA Manager, you will play a pivotal role in driving the reduction of registration cycle time through Speed to Market initiatives. You will work closely with the Regional/Global RA team to expedite product registrations in Thailand. Your understanding of the Thailand regulatory environment will be crucial as you leverage key relationships with industry groups. Your focus will be on new product registration and paperwork, assisting the commercial team on product artworks and labelling compliance. You will also manage people, budget and resources of Regulatory Affairs while supporting Pharmacovigilance activities.

  • Drive reduction of registration cycle time through Speed to Market initiatives.
  • Work closely with Regional/Global RA team to obtain complete registration documents for faster product registrations in Thailand.
  • Understand and influence Thailand regulatory environment by leveraging key relationships with industry groups.
  • Focus on new product registration and paperwork.
  • Assist commercial team on product artworks and labelling compliance.
  • Notify and update Thailand employees in all regulatory related subjects.
  • Manage people, budget and resources of Regulatory Affairs.
  • Support Pharmacovigilance including submitting adverse reactions/events reports to Thai FDA, notifying the Thai FDA of any significant safety issues, and ensuring data requests from Thai FDA are answered fully and within the requested timeframe.

What you bring:

The ideal candidate for this RA Manager position brings a wealth of experience from the pharma and medical device industrial field. With over 8 years in the industry, you have developed strong interpersonal skills that allow you to connect with both internal and external counterparts. Your strong English communication skills will be essential in this role, as you will be required to liaise with various stakeholders. Your experience in people management and your ability to support PhV, MV, Quality incidence management, NBD and advertisement management will set you apart.

  • Bachelor’s degree in pharmacy is mandatory
  • 8+ years experiences in pharma and medical device industrial field
  • 3+ years proofed people management experiences
  • Experiences with extended supports to PV, MV, Quality incidence management, NBD and advertisement management are desired
  • Good inter-personal skills with internal and external counter parts
  • Strong communication skills in English (both written and spoken)

What sets this company apart:

Our client is a global leader in their field, committed to improving the quality of life for individuals around the world. They are known for their innovative products and commitment to excellence. They offer a supportive and inclusive work environment where every employee is valued and given opportunities for professional growth.

What's next:

If you're ready to take the next step in your career, apply today!

Apply today by clicking on the link!

Keywords: Pharmacy, Regulatory Affairs, People Management, English Communication

Due to the high volume of applications, our team will only be in touch if your application is shortlisted.

Robert Walters Recruitment (Thailand) Limited
Recruitment License No.: น. 1188 / 2551

Contract Type: FULL_TIME

Specialism: Sales

Focus: Account Management

Industry: Pharmaceuticals

Salary: Negotiable

Workplace Type: On-site

Experience Level: Mid Management

Location: Bangkok Province

Job Reference: QM2KGZ-621D30F3

Date posted: 05 June 2024

Consultant: Sujintra Thairatanakul

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