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Quality Safety Regulatory Manager

3 weeks ago

Việt Nam, Vietnam Blackmores Group Full time

Blackmores Group is a leading natural health company with proud Australian heritage, with extensive reach across Asia Pacific. Founded by visionary naturopath Maurice Blackmore in 1932, our vision is to connect every person on earth to the healing power of nature by combining our knowledge of nature and science to deliver quality health solutions to people and their pets everywhere, every day.

Blackmores Group operates in over 11 markets, with headquarters and a state-of-the-art manufacturing facility in Australia, and offices across South East Asia and China.

As a purpose-led, performance-driven organisation, Blackmores Group strives to create remarkable employee experiences through supporting a diverse and inclusive culture, creating leadership that inspires high performance, and providing everyone with opportunities to achieve their professional, personal and wellbeing goals supported by our flexible work practices and family friendly policies.

**Purpose of role**:
This role will be responsible to lead and champion the local market product quality support, product issue resolutions related to imported finished goods, quality audit and regulatory functions.

**Responsibilities include**:
**Local Market Product Quality Responsibilities**
- Manage and resolve warehouse / distribution issues and compliance, via NCRs.
- Manage temperature datalogger excursions (as applicable)
- Perform routine reviews and audits of the distribution centres.
- Attend the Distribution centre to assist in resolving product quality issues.
- Generating and managing NCRs (non-conforming reports) for local distribution issues.
- Co-ordinate local laboratory testing as required.
- Log and report Customer Complaints and Product Safety Issues into Blackmores business systems. Assist with follow up support as directed.
- Ensure appropriate procedures and documentation is in place as related to Customer Complaints and Pharmacovigilance programs.
- Assist with counterfeit and product tampering queries and assessments.
- Perform on-site audits on local market or regional manufactures as directed.
- Liaise with the local regulator for Quality related issues as directed or required.
- Assist with counterfeit and product tampering queries and assessments.
- Provide local market recall support.
- Maintain and develop local market QA Documentation (processes and procedures)

**Local Market Regulatory Responsibilities**
- Review product specification to ensure compliance with local regulation.
- Review artwork for compliance to local regulation.
- Generate accurate English translation of artwork and relevant dossiers for filing in Head Office.
- Submit sample for testing as required.
- Co-ordinate registration submission to local regulatory authority.
- Negotiate successful regulatory approvals.
- Liaise with Regulatory personnel in Head Office of any regulatory issues.
- Provide regulatory advice to support regulatory compliance.
- Build and develop relationships with key regulators, industry organisations and key market regulatory contacts
- Develop and implement strategies to negotiate successful regulatory approvals and minimize regulatory approval times.
- Ensure systems and processes are in place to achieve compliance with legal requirements and corporate policies
- and promote the values, image and role of Blackmores to all team members; demonstrate
- Proactively identify, correct, and resolve compliance issues
- Provide strategic advice on the registration pathway of new product formulations and regulatory opportunities for business growth

**Who are you?**
- Relevant Degree in Pharmacy or Science/ Nutrition qualification.
- Minimum 10 years of relevant experiences in Quality / Regulatory Affairs roles
- Strong writing skills in Technical / SOP writing
- Software Applications - MS Word, Excel, PowerPoint and Outlook, Enterprise One, Access, SharePoint
- Strong understanding of the business landscape & cultural nuances of business operations in Vietnam
- Proficiency in both Vietnamese & English is highly desirable
- Excellent communication, negotiation & interpersonal skills
- Strong strategic thinking and executional skills, capable of building for simplicity, scale and repeatabilityA team player with strong skills in the areas of influencing, motivation, relationship building, and communication.
- Agencies please note: this recruitment assignment is being managed directly by Blackmores Talent Acquisition team. We will reach out to our preferred agency partners if required. Your respect for this process is appreciated._