With our global presence, brands and business within our mission,bringing health through food to as many people as possible; we believe that people growth is a key asset to reach a sustainable business performance. Take this opportunity to GROW together!
The position is REGULATORY AFFAIRS LEAD MANAGER, You'll responsible to
- Coordination / Monitoring all NPD or registration to build or innovate or renovate product portfolio within ELN CBU.
- Coordination and management of market verification of product labeling and claim validation material (including reporting, defining and following‐up action plan, result analysis) in order to maintain product compliance refer to the local regulation.
- Coordination of response generation (as well communication) to the authority’s inquiries or complaints.
- Coordination, supervision and management of internal audit (Danone Way, DanGo test, etc.) & external audit (i.e. PMR, CPPOB, etc.) done by government agencies
- Organize regular up date of existing procedure and provide required procedure within regulatory, specifically related to ELN CBU according to the development needs.
- Provide up-date and overview of new regulation / requirement / policy from relevant government agencies and set up impact analysis and internal recommendation as anticipation to internal organization/business.
- Coordination and optimization of claim validation activities of promotional materials brands dedicated for ELN CBU to be aligned with local regulation, global direction (if applicable) and available supporting data and generate appropriate recommendation.
- Regular review of the CVM Procedure and update whenever applicable, especially when new relevant regulation is available.
- Scientific representation / liaison within industry and professional associations as well as government agencies, related to ELN CBU business (i.e. APPNIA, BPOM, MoA, MoI)
- Actively involved in the regulation development at relevant authorities via the associations.
Education & Experience :
- Bachelor Degree preferably in Food Technology or Biochemistry or pharmacy
- Strong Regulatory experience
- Strong external network with key stakeholders
Skilss & Competency :
- Functional competencies : strong regulatory expertise
- Management & leadership Competencies :
- Strategic and flexible thinking
- Agility and ability to manage complexity
- Make justified recommendations
- Business Acumen
- Collaborative mindset & attitudes
- Ability to maintain networks internally and externally
- Strong communication and negotiation skills
- Internal and external impact and influence
- Strong integrity values
Please send your resume (maximum 1.5 MB) to firstname.lastname@example.org with email subject: SF - REGULATORY AFFAIRS LEAD MANAGER
Only shortlisted candidates will be informed.
Regulatory Affairs, Law, Compliance, Manager, Internal Audit, Legal, Management, Finance