Regulatory Affairs Specialist, Human Pharma
2 months ago
**The Position
**Regulatory Affairs **Specialist **, Human Pharma
- To achieve timely & successful product registrations in accordance with corporate & local strategies.
- To collect any information on new Regulations and Guidelines, and to share it in local RA team.To ensure compliance with Company regulatory policies, regulations & procedures.
**Duties & Responsibilities**
**1. Regulatory Planning and Submission**
- Manage all the regulatory tasks & projects, including attaining, maintaining product licenses and operation licenses for assigned portfolio on behalf of Boehringer Ingelheim as required by local r egulations.
- Monitor progress of submissions & coordinate timely responses to all questions from the health a uthorities.
- 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
**2. Regulatory Intelligence and Interaction**
- Responsible to collect new or updated local regulations via various potential sources and keep the local RA team and ROPU informed
- Communicate with Regulatory Authorities and local industry groups on regulatory issues
**3. Cross-functional collaboration and support**
- Provide regulatory consultation & collaborate with local business stakeholders
- Provide feedback to the implementation of 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
- Support local inspection readinessArchiving of local regulatory submission documents
**Requirements**:
**Minimum Education **/ **Degree Requirements**:Bachelor’s degree in Pharmacy preferred
**Skills required**:
- Good knowledge of National Drug Regulations and Procedures
- Good communication skills for internal & external interactions
- Proactive and assertive attitude
- English proficiency
- Good computer literacy skills, comfortable working with databases
**Experience**:Minimum 3 years of experience working in the pharmaceutical, medical device or healthcare industry with strong performance record in the previous position.
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