Regulatory Affairs Specialist, MSI

Boehringer Ingelheim; Kuala Lumpur; On-site; MYR 70,000 - 95,000; Full time

Job summary

A leading global pharmaceutical company in Kuala Lumpur is seeking a Regulatory Affairs Manager to oversee product registrations and ensure compliance with regulations. The ideal candidate should have a degree in Pharmacy or Life Sciences and 2-5 years of relevant experience. Responsibilities include managing regulatory submissions, providing consultation, and maintaining a regulatory database. This role is pivotal for driving healthcare innovation and collaboration across teams.

Qualifications

• 2-5 years of experience in pharmaceutical, medical device, or healthcare industry.
• Good knowledge of national drug regulations and procedures.
• Meticulous attention to detail.

Responsibilities

• Manage regulatory tasks and maintain product licenses.
• Compile registration applications and ensure timely approvals.
• Communicate with regulatory authorities on compliance issues.

Skills

Regulatory compliance

Strong communication skills

Analytical mindset

Computer literacy

Education

Degree in Pharmacy or Life Sciences

Tools

Q3+

Prism

Job description

The Position

Are you ready to take on a role where your regulatory expertise drives healthcare innovation forward? This role is responsible for achieving timely and successful product registrations in accordance with corporate and local strategies, collecting and sharing updates on new regulations and guidelines with the local RA team, and ensuring compliance with company regulatory policies, regulations, and procedures.

Tasks and Responsibilities:

1. Regulatory Planning and Submission
   • Manage regulatory tasks & projects, including attaining and maintaining product and operation licenses for assigned portfolio
   • Compile registration applications for assigned portfolio and ensure timely approval
   • Monitor submission progress and coordinate timely responses to health authority queriesComply with corporate policies, regulations & procedures, including CCDS, CRC, and local change control processes
2. Regulatory Intelligence and Interaction
   • Collect new or updated local regulations from various sources
   • Share regulatory updates with the local RA team and ROPU
   • Communicate with regulatory authorities and local industry groups on regulatory issues
3. Cross-Functional Collaboration and Support
   • Provide regulatory consultation to local business stakeholders
   • Collaborate with internal teams and contribute to global initiative implementation
4. Quality and Compliance
   • Submit CCDS, CRC, renewals, PSURs, and other local variations in line with internal KPIs
   • Maintain regulatory database to reflect current registration status and requirements
   • Support local inspection readiness
   • Archive local regulatory submission documents

Requirements:

• A degree in Pharmacy (preferred) or another degree in Life Sciences
• Two to five years of experience in the pharmaceutical, medical device, or healthcare industry
• Good knowledge of national drug regulations and procedures
• Strong communication skills for internal and external interactions
• Solid computer literacy and comfort working with database such as Q3+ and Prism
• Analytical mindset with meticulous attention to detail

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.