Regulatory Executive

PharmEng Technology Pte Ltd; Kuala Lumpur; On-site; MYR 200,000 - 250,000; Full time

Job summary

A leading company in the pharmaceutical consulting industry seeks a Regulatory Executive to ensure compliance with regulatory standards. The role involves strategic support for regulatory processes, managing product registrations, and collaborating with cross-functional teams. Ideal candidates should have a degree in Pharmacy or related fields and a willingness to learn with some relevant experience. Join a dynamic team committed to delivering solutions in the healthcare space!

Qualifications

• Willingness to stay up-to-date with industry developments.
• Looking for junior with internship / 1 year experience.
• Fluency in English and proficiency in regulatory processes.

Responsibilities

• Manage regulatory activities such as new product registrations and updates.
• Ensure compliance with internal policies and regulatory standards.
• Act as the primary contact for regulatory submission processes.

Skills

Project Management

Strategic Thinking

Problem Solving

Communication

Leadership

Education

Degree in Pharmacy

Degree in Life Sciences or related field

Job description

About the role

As a Regulatory Executive, you will involve working closely with cross-functional teams to ensure all products meet the necessary regulatory standards and requirements. The individual is expected to provide strategic input for regulatory processes, contribute to the development of new products, and actively engage in regulatory discussions and updates.

What you'll be doing

Strategic Support and Innovation:

Provide expert consultation on regulatory requirements, including verifying strategies and timelines.

Manage a range of regulatory activities, such as new product registrations, updates, renewals, and compliance submissions.

Develop and implement regulatory strategies in collaboration with regional and local teams.

Work with medical and regulatory teams to ensure timely submission of products aligned with project timelines.

Coordinate and oversee the implementation of strategic and operational regulatory activities for assigned projects.

Product Maintenance and Compliance:

Ensure ongoing maintenance of product registrations and manufacturing site compliance.

Update internal systems and databases promptly following company procedures.

Manage packaging and labeling processes, ensuring adherence to local regulatory requirements.

Oversee translations and document archiving, ensuring accessibility and compliance with local and global systems.

Review and approve both promotional and non-promotional materials, ensuring they meet market-specific regulatory standards.

Stakeholder Collaboration and Issue Resolution:

Act as the primary contact for regulatory submission processes, addressing issues and escalating concerns as necessary.

Coordinate submission documentation and ensure proper tracking and communication with relevant teams.

Provide updated regulatory requirements and insights to global and regional teams to support compliance and documentation preparation.

Identify gaps in regulatory documentation and collaborate with quality assurance teams to address deviations and establish corrective actions.

Monitor submission statuses, escalate risks, and communicate regulatory updates across relevant functions.

Representation and Additional Duties:

Represent the organization in interactions with government authorities and industry associations.

Handle other tasks assigned by regulatory leadership.

Scope of Responsibility:

Collaborate closely with local and regional colleagues across multiple functions.

Ensure compliance with internal policies, regulatory standards, and local requirements.

Skills and Qualifications

Degree in Pharmacy, Life Sciences or a related field

Willingness to stay up-to-date with industry developments and regulatory changes

Looking for junior with internship / 1 year experience to do remote work for Singapore, training will be provided.

In-depth knowledge of regulations governing pharmaceuticals, health supplements, and cosmetics.

Fluency in English and proficiency in regulatory processes, quality systems, and risk management.

Strong skills in project management, strategic thinking, problem-solving, communication, and leadership.

Apply now to join our team as a Regulatory Executive!

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Your application will include the following questions:

What's your expected monthly basic salary? Which of the following types of qualifications do you have? How many years' experience do you have as a Regulatory Affairs Executive? Which of the following languages are you fluent in? Have you worked in a pharmacy before? How would you rate your English language skills? Do you have experience working for an industry association?

Pharmaceuticals, Biotechnology & Medical 51-100 employees

Headquartered in Toronto, Canada, PharmEng Technology is a global Consulting company, providing cross-border services in Engineering and Regulatory Affairs for the Pharmaceutical, Biotechnology and Medical Device industries. PharmEng offers a broad range of services such as Product Development, Project Management, Engineering, cGMP, Validation, Qualification, Calibration, Regulatory Affairs and Training etc.

We assist companies from strategic planning to commercialization, from clinical to manufacturing process scale up, final production, and to regulatory approvals, so as to meet regulatory compliance to bring safe and efficacious Therapeutic Products for marketing approvals across the world.

The culture at PharmEng Technology is one of creativity, collaboration, and a team that delivers.

We continuously seek talented people to become part of our team. We invite you to explore opportunities at PharmEng Technology if you possess the scientific and/or engineering skills coupled with the ability to create and communicate innovative and cost-effective solutions. Whether you’re a seasoned professional or a new graduate, PharmEng has numerous challenging and rewarding career opportunities that may interest you.

Headquartered in Toronto, Canada, PharmEng Technology is a global Consulting company, providing cross-border services in Engineering and Regulatory Affairs for the Pharmaceutical, Biotechnology and Medical Device industries. PharmEng offers a broad range of services such as Product Development, Project Management, Engineering, cGMP, Validation, Qualification, Calibration, Regulatory Affairs and Training etc.

We assist companies from strategic planning to commercialization, from clinical to manufacturing process scale up, final production, and to regulatory approvals, so as to meet regulatory compliance to bring safe and efficacious Therapeutic Products for marketing approvals across the world.

The culture at PharmEng Technology is one of creativity, collaboration, and a team that delivers.

We continuously seek talented people to become part of our team. We invite you to explore opportunities at PharmEng Technology if you possess the scientific and/or engineering skills coupled with the ability to create and communicate innovative and cost-effective solutions. Whether you’re a seasoned professional or a new graduate, PharmEng has numerous challenging and rewarding career opportunities that may interest you.

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What can I earn as a Regulatory Affairs Executive