Mega Lifesciences Public Company Limited

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Manager - Scientific & Regulatory Affairs Pharmacist (Pharmaceutical)

Mega Lifesciences Public Company Limited

Urgently Required!Only English resume will be considered.

Medical/Pharmaceutical/Medical equipment

18/11/2024

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Basic Requirements

Full Time

5 - 10 Year

Bangkok (Bangna)

Bachelor's Degree or Higher

60,000 - 100,000 baht/month

Responsibilities

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

• Manage all activities related to product registration for Pharmaceutical products, OTC, Ethical, Biological products and other categories.

• 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

• Develop and coach team members to meet goals and objectives set

• Lead the team to ensure prioritized objectives that focus on the critical activities are successfully delivered on time and on quality

Requirements

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

• Bachelor’s Degree or Master’s Degree in Pharmacy

• At least 5 years experiences management in pharmaceutical industry or in Drug Regulatory affairs

• Pharmaceutical products, OTC, Ethical, Biological products and other categories is an advantage

• A pharmacist license is necessary.

• Good networking skills and result-oriented

• Professional use of MS Office

• Proficiency in English language – speak, read, write

• Ability to multitask and deliver on multiple projects.

• Excellent working relationship with Thai FDA and demonstrated success in key negotiations

• Open & interested in working in Bangna, Bangkok.

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.

Benefits:

• Salary increment

• Annual leave

• Yearly bonus (paid twice a year)

• Provident fund

• Life insurance

• Medical insurance/reimbursement (IPD & OPD)

• Annual health check-up

• Uniform

• Annual Party

• Good Health by Yourself activities

• Shuttle bus/van

• Special Price Products

• etc.

If you are eager to make the most of this opportunity, then press APPLY in this job posting OR please send your resume via careers@megawecare.com with "Job Application No: HCD/2024/RTH12 - (Applicant's name)"

For further information, please call 02-769 4222 ext. 3019 (K.Time)

Welfare and Benefits

Health checkup
Medical reimbursement
Salary increment
Provident Fund
Staff training and development
5-day work week
Employee's uniform
Annual trip or party
Annual bonus

Mega Lifesciences Public Company Limited

About Company

Mega Lifesciences Public Company Limited

Established in 1982, Mega Lifesciences public company limited is actively involved in helping millions of people have access to safe, effective, world class quality nutritional & herbal supplements, OTC and pharmaceutical products. From Thailand to the world, Mega is engaged in manufacturing, marketing, selling and distributing quality pharmaceutical, nutraceutical products and Fast Moving Consumer Goods (FMCG). Headquartered in Bangkok, we have our presence in more than 30 countries across the globe.

At MEGA,

We care for the CUSTOMER – the doctor, the retailer & YOU.

We care for “Human Wellness”; our first objective is to help people stay healthy.

Our values are based on Truth, Trust, Respect and Freedom.

Our way of life provides a learning environment wherein you change before you are forced to and help to build a Company that will live beyond each of us.

We create value by marketing and selling medicines in developing countries.

• With two world class manufacturing facilities in Thailand and one in Australia, Mega operates over 30 countries employing more than 5,000 colleagues.

• At Mega you will drive your future and the future of this Company.

Mega Lifesciences India is a subsidiary of Mega Lifesciences Public Company Limited, Thailand. With two world class manufacturing facilities in Thailand and one in Australia, Mega operates over 31 countries employing 5,500 colleagues and has an annual revenue of over USD 370 Million (FY-18). Mega features in top 20 pharmaceutical companies as per IQVIA MIDAS Thailand (MAT Dec. 2017) in branded generic & Non Rx bound product category.

At Mega, you will drive your future and the future of this Company.