
Ra Specialist
2 weeks ago
Overview:
**FUNCTION/DEPARTMENT: INTELLECTUAL PROPERTY AND REGULATORY AFFAIRS (IPRA)**
**REPORTING TO: IPRA MANAGER/ASSOCIATE MANAGER**
**DIRECT REPORTS: NIL**
**Responsibilities**:
**RESPONSIBILITIES**:
- Manages regulatory projects registrations, including preparation of registration dossier, submission and follow up with regulatory authorities
- Maintains and renews existing product licenses
- Keeps up to date with changes in regulatory legislation and guidelines in Asia Pacific countries and sharing the information within the organization
- Interprets and provides regulatory guidance to cross functional team including manufacturers, scientists and marketing and sales colleagues
- Reviews labels, marketing materials for accuracy and regulations compliance
- Responds to customers’ requests and resolves issues regarding regulations and compliance matters
- Supports the RA functional Head in various other activities as assigned
- Studies related scientific and legal documents
- Writes comprehensible and clear product information leaflets
- Offers advice about company policies, practices and systems
- Ensures that company’s Intellectual properties are protected
LI-LC1
Qualifications:
**QUALIFICATION**:
- Degree in Science (Biochemistry/ Chemistry/Microbiology/Food Science/ Biotechnology/ biomedical science/ Pharmaceutical science etc.) or equivalent from a reputed University
**SKILLS & EXPERIENCE**:
- 3 years of regulatory experience
- Animal feed additive registration experience preferred.
- Self-motivated and meticulous with good organizational, negotiation skills
- Must have high level of integrity to handle confidential company information
- Good writing and communication skill required
- Must be able to work independently in a fast-paced multidisciplinary environment, with diverse group of people
- Active team player with excellent interpersonal skill
- Advanced computer knowledge (Word, Excel, Access, PowerPoint, etc.)
- Experience in authoring of Safety Data Sheets (SDS) for Asia Pacific countries would be preferred
- Able to multi-task and consensus to follow up with administrative duties and/or paperwork
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