Job Description

The Position

• To achieve timely & successful product registrations in accordance with corporate & local strategies.
• To update the Company on new Regulations and Guidelines, and to ensure the Company complies with the local legislations & industry codes governing the import and control of therapeutic products.
• To ensure compliance with Company regulatory policies, regulations & procedures.
• Design and assess local regulatory plans including new strategic concepts and license opportunities and provide consolidated input on key regulatory development in cross-functional team meetings.

Duties and Responsibilities

1. Regulatory Planning and Submission Strategy

• Manage all the regulatory tasks & projects, including attaining, maintaining product licenses and operation licenses for assigned portfolio on behalf of BI as required by local regulations
• Prepare and submit regulatory applications for assigned portfolio and ensure timely approval
• Develop local registration plans in alignment with local business and global regulatory strategy
• Monitor progress of submissions & coordinate timely responses to all questions from the health authorities for assigned portfolio
• Be Compliant with Corporate policies, regulations & procedures, in particular implementation of current Company Core Data Sheet (CCDS), Change Review Committee (CRC) and local change control procedures
• Management of regulatory submissions to support clinical trial activities in the OPU (if applicable)

2. Regulatory Intelligence and Interaction

• Responsible to keep the local RA team and ROPU informed of new regulations or updates
• Ensures a regulatory impact assessment in timely manner
• Close relationships with relevant health authorities and other organizations/key stakeholders to facilitate and develop effective collaboration on regulatory interactions.
• Communicate with health authorities and local industry groups on regulatory issues

3. Cross-functional collaboration and support

• Provide regulatory consultation & collaborate with local business stakeholders
• Ensures that product promotion in the market is in compliance with the local and global regulatory framework, in order to sustain and expand the business.
• Participates in the promotional material approval process in order to ensure regulatory compliance regarding these promotional materials and activities
• Provide feedback to global and participate in global initiatives when required

4. Quality and Compliance

• Timely submission of CCDS, CRC, Renewals, PSUR and other local variations in compliance with internal KPIs
• Ensures that regulatory database is up to date to reflect the current registration status or regulatory requirements
• Ensure that timelines for regulatory review in the e-MLR process are met and promotional materials comply with local regulations
• Contribute to audits, CAPA process as appropriate and support local inspection readiness
• Archiving of local regulatory submission documents

5. Deputy for Head of Regulatory Affairs and training support to local RA team(if applicable)

• Fulfill the responsibilities of the Head of Regulatory Affairs in his/her absence
• Act as mentor in providing guidance and actively train other team members in regulatory tasks where appropriate

Requirements

• Degree in Pharmacy preferred
• >5 years of experience in the pharmaceutical, medical device or healthcare industry
• Experience in regulatory affairs or relevant discipline is preferred
• Solid understanding of drug development
• Good knowledge of National Drug Regulations and Procedures
• English proficiency
• Good communication skill for external and internal interactions
• Good computer literacy skills, comfortable working with databases
• Strongly support and effectively work within the matrix organization
• Interact with health authority
• Demonstrate thorough understanding of local regulatory requirements and has technical regulatory knowledge in at least one therapeutic area or technical area (CMC, clinical)
  

Ready to contact us?

Please contact our Recruiting ASKAN Team: PHI +632 8876 6899 | SGP +65 6419 8822 | MYS +603 2092 0041

Note to Recruitment Agencies:

Boehringer Ingelheim (BI) does not accept candidate submissions from recruitment agencies that BI does not have existing contracts with. BI will not be responsible for payment of recruitment fees for the hiring of candidates whose resumes were submitted to BI employees or BI offices without BI\xe2\x80\x99s prior permission.