Senior Specialist, RA

Baxter International Inc.; Petaling Jaya; On-site; MYR 180,000 - 300,000; Full time

Job summary

Baxter International Inc. in Malaysia is seeking a Regulatory Affairs professional to lead local regulatory and quality activities.

You will obtain and maintain marketing authorizations for drugs, biologics and medical devices, ensuring compliance with local regulations and licensing requirements. Under limited supervision, you will develop regulatory project plans, identify regulatory risks, prepare submissions, and provide guidance to project teams.

Qualifications

• At least 5 years of relevant experience in pharmaceutical, biologics and medical devices in Malaysia.
• Degree in pharmacy, science or related discipline is an advantage.
• Pharmacist license is an advantage.
• Knowledge of regulatory laws and GDPMD considerations in Malaysia.

Responsibilities

• Lead local regulatory activities and strategy for drugs, biologics and medical devices.
• Prepare, submit and maintain regulatory documents in compliance with local requirements.
• Develop regulatory project plans and identify regulatory risks.
• Provide regulatory advice to project teams and respond to authorities within timelines.
• Prepare labeling and SOPs reflecting local requirements and guide junior staff.

Skills

Regulatory project management

Regulatory compliance

Communication skills

Interpersonal skills

Negotiation skills

Education

Degree in pharmacy or science

Pharmacy degree

Job description

This is whereyour work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

Role Summary

Under limited supervision responsible for the local implementation of regulatory and quality activities and strategies, obtain and maintain marketing authorizations for product(s) and communication of local regulatory requirements in support of licensing of drugs, biologics and medical devices products.

Area of Responsibility (AOR) for Role

• Strong experience in drugs and biologics
• Relevant experience in medical devices in Malaysia
• With direction, develop and execute regulatory project plans
• Identify and elevate key areas of regulatory risk
• Maintain awareness of regulatory requirements; identify relevant requirements
• Participate as an active team member and provide regulatory advice to project teams as required
• Respond to questions from regulatory authorities within strict timelines
• Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
• Maintain and update existing regulatory authorizations
• Support regulatory activities relating to specific portfolio of products/projects
• Prepare, review, and approve labeling and review AdProm materials for compliance with local regulations
• Prepare SOPs to reflect specific local requirements.
• Represent or lead Regulatory Affairs in small project teams
• Provide guidance to junior team members when needed
• Perform other duties as assigned

Work Qualitication/Experience

• At least 5 years of relevant experience in pharmaceutical, biologics and medical devices in Malaysia
• Degree in pharmacy, science or related discipline is an advantage.
• Pharmacist License is an advantage

• Well-versed with new registration, license extensions, variations and renewals in Malaysia. Experience with both drugs and medical device registration is an advantage.
• Knowledge of applicable regulatory laws and acts and well-versed with changing scope and evolving regulations
• Knowledge of regulations and well-versed with changing scope and evolving regulations
• Good understanding of GDPMD
• Project management skills
• Manage multiple projects and deadlines
• Ability to multitask and prioritize
• Interpersonal and communication skills
• Negotiation skills
• Technical system skills (e.g. word processing, spreadsheets, databases, online research)
• Ability to identify compliance risks and elevate when necessary

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally.

Recruitment Fraud Notice

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