Senior Manager - Scientific & Regulatory Affairs

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Senior Manager - Scientific & Regulatory Affairs

Senior Manager - Scientific & Regulatory Affairs

SRA Office, Pak-kret, Nonthaburi, Thailand
Full-time
Scientific & Regulatory Affairs

Work Location: SRA Office, Pak-kret, Nonthaburi, Thailand
Reference No.: HCD/2022/RTH17

Have you always been a coach?
Are you always seeing a better world?
Do you have a knack for knowing how to partner with people?

Mega Lifesciences is looking for Senior Manager – Scientific & Regulatory Affairs to work closely with Director – Scientific & Regulatory Affairs in a fast-paced environment that will offer ample opportunity to learn and expand your experience and expertise.

Job Summary

As a Senior Manager – Scientific & Regulatory Affairs, your key tasks are as below:

  • Manage all activities related to product registration for pharmaceutical products, chemical & biologics for ethical, OTC, medical device, cosmetic, foods and other products.
  • Review and evaluate the product documentation along with coordination for any additional documents, clarifications, samples, etc. as required for product registration.
  • Make sure that all submissions/approvals comply with the laws, guidelines, regulations and practices in Thailand.
  • Communicate the approved information &/or any changes to the concerned departments within/outside the company.
  • Take initiative in local government affairs activities by cultivating close relationships with government agencies in order to influence and respond proactively to the development of laws and regulations governing product registrations.
  • Provide input and advance notification on potential regulatory & quality risks and propose/develop preventive and corrective strategies by exploring ways for registrations.
  • Maintain a high level of regulatory intelligence by staying abreast on existing and developing regulations, guidelines, laws and overall competitive landscape in the regulatory domain.
  • Manage and coordinate all Pharmacovigilance activities for the products according to Thai FDA regulations.
  • Ensure documentation of the registered products.

Qualification & Experience

Applications are invited from the candidates who meet the following criteria:

  • Incumbent must be a Thai national.
  • Bachelor’s Degree or Master’s Degree in Pharmacy.
  • At least 10 years experiences in pharmaceutical industry or in Drug Regulatory affairs.
  • Experience in product registration for pharmaceutical products, chemical & biologics for ethical, OTC, medical device, cosmetic, foods and other products is an advantage.
  • Excellent working relationship with Thai FDA and demonstrated success in key negotiations.
  • Good networking skills and result-oriented.
  • Professional use of MS Office.
  • Fluency in English language – speak, read, write.

Skill & Knowledge

The ideal candidate must possess excellent knowledge and understanding of regulatory compliance and strong knowhow of local regulatory requirements for product registration. Good skills in coaching and mentoring, management and leaderships, analytical and problem-solving skills to resolve regulatory challenges.

If you are eager to make the most of this opportunity, kindly fill in the details in respective fields and submit your application for the position.

For any further clarification and information related to the position, you may please contact +66(0)2 769 4222 ext. 3019 (Mr.Thachacharn).

Apply Now

Kindly fill your details and submit your application.
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