Job Title: Regulatory Affairs Specialist, Human Pharma
Job ID: 16498
Location: [Location]
Position Overview
As a Regulatory Affairs Specialist in Human Pharma, you will play a key role in achieving the timely and successful registration of products, in alignment with both corporate and local strategies. This position involves staying up to date with new regulations and guidelines, ensuring compliance with Boehringer Ingelheim’s regulatory policies, and supporting local regulatory affairs (RA) teams.
Key Responsibilities:
1. Regulatory Planning and Submission
Manage all regulatory tasks and projects related to the assigned portfolio, including obtaining and maintaining product licenses and operation licenses, as required by local regulations.
Prepare and submit registration applications for assigned products, ensuring timely approval.
Monitor the progress of submissions and coordinate responses to any queries from health authorities.
Ensure compliance with Boehringer Ingelheim's policies and procedures, including the implementation of the Company Core Data Sheet (CCDS), Change Review Committee (CRC), and local change control procedures.
2. Regulatory Intelligence and Interaction
Collect and share updated local regulations and guidelines with the local RA team and the broader regulatory affairs organization.
Communicate with regulatory authorities and local industry groups on regulatory matters.
3. Cross-functional Collaboration and Support
Provide regulatory consultation and support to local business stakeholders.
Contribute feedback for the implementation of global initiatives when required.
4. Quality and Compliance
Ensure the timely submission of CCDS, CRC, renewals, PSUR, and other local variations in compliance with internal key performance indicators (KPIs).
Maintain up-to-date regulatory databases reflecting current registration status or regulatory requirements.
Support local inspection readiness.
Archive regulatory submission documents locally.
Qualifications:
Education & Experience:
Bachelor’s degree in Pharmacy (preferred).
At least 3 years of experience in the pharmaceutical, medical device, or healthcare industry, with a proven record of strong performance in previous roles.
Skills & Competencies:
Solid knowledge of National Drug Regulations and Procedures.
Excellent communication skills for both internal and external interactions.
Proactive and assertive attitude in managing tasks.
Proficiency in English (both written and verbal).
Strong computer literacy skills, including the ability to work with databases.
Contact Information:
For more details or to apply, please reach out to our recruiting team:
Ms. Phuong Vo
Email: phuong.vo@boehringer-ingelheim.com
About Boehringer Ingelheim:
Boehringer Ingelheim is a leading pharmaceutical company that develops groundbreaking therapies to improve the health of both humans and animals. Founded in 1885 and still family-owned, Boehringer Ingelheim operates globally with over 52,000 employees. The company values diversity, collaboration, and innovation, empowering its employees to reach their full potential.
Why Boehringer Ingelheim?
At Boehringer Ingelheim, we foster an environment where you can grow, collaborate, and innovate to improve lives. We offer a dynamic, respectful global work environment and focus on the professional development of our employees. As an equal-opportunity employer, we are committed to diversity and inclusion, benefiting our employees, patients, and communities.
To learn more, visit: Boehringer Ingelheim Careers.
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