Regulatory Affairs & Category Compliance Manager, Specialized Nutrition (SN) at Danone

• Manage all Regulatory Affairs and Category Compliance activities on behalf of Danone Nutricia Africa (DNAF) for Southern Africa & export countries within the scope of Specialized Nutrition (SN) division: baby food products and medical nutrition. 
• Protect and support Danone’s business and assets by designing and implementing the optimal regulatory framework & category compliance strategy, according to country regulations, company policies and the specific needs of the central business unit.
• Bring regulatory expertise and make recommendations to guarantee the conformity of the products and communication within the countries.
• Educate the local teams to enable them to have an enlightened vision of the regulatory and compliance issues, provide them with guidelines to make the best decisions, and accompany them in the defined actions.

KEY ACCOUNTABILITES

REGULATORY:

• Keep abreast of current and pending regulations and trends relating to the composition, labelling, advertising, registration, communication and importing of SN products to ensure and prepare for regulatory compliance.  Define the impact of new regulations and develop mitigation plans to minimise impact and ensure compliance.  Implement and manage actions relating to regulatory compliance while informing local and global teams. 
• Be a proactive and enabling partner according to business objectives and context.
• Acts as local advisor to WHO code compliance.
• Engage with regulatory authorities, competitors, or other stakeholders. 
• Be the point of contact for authority requests and team queries.
• Form part of the crisis management team as required.
• Develop and cultivate an active set of relationships with regulatory organisations, stakeholders, self-regulatory groups and industry association and stakeholders. 
• Participate actively in the Danone Africa regulatory network (regular calls, meetings, sharing of best practice)
• Be integrated in key project teams by identifying regulatory constraints/risks in project, assisting in decision making, and escalating important topics to the global team
• Train the team (and all new starters) on requirements of regulatory compliance (including local and international regulations and guidelines).
• Actively participate as part of relevant trade associations in collaboration with the public affairs team (participate in meetings, propose relevant topics, share feedback with the business).

PRODUCT REGISTRATION

• Be informed and provide direction relating to each country’s registration requirements.
• Collate and submit documentation needed for product registration.
• Be the identified contact for local authorities in collaboration with Public Affairs.
• Respond to all Danone global requests and authorities’ requests.
• Assist with the registration of products in export countries.
• Monitor and manage registration authorization in accordance with the timetable.

COMMUNICATION & LABEL VALIDATION

• Review and pre-validate all external communication relating to SN in line with local regulations. 
• Follow & respect the Group Claim procedure (communication validation).
• Carry out regular checks to ensure that the procedure is being properly followed.
• Train all newcomers on the process.
• Provide input about local regulations to ensure that recipe changes are compliant, to provide label specification.
• Check and validate the label for SN products.

CATEGORY COMPLIANCE

• Deploy and animate the Category Compliance program for South Africa & export countries.
• Ensure team awareness and compliance to the internal procedures relating to the commercialisation of our products.
• Train teams on Category Compliance, Healthcare Systems procedure (HCS), Breastmilk Substitute Do’s & Don’ts (all new-comers, regular training for people in the field, regular knowledge testing, training on internal procedures).
• Review and approve HCS request forms.
• Performs or support internal audit, propose and follow a compliance action plan.
• Offer support for external audit preparation & follow action plan. 
• Monitor non-conformities report and implement plans for corrective action.   
• Participate in a compliance network (regular communication, participation in calls, sharing best practices)

KEY DELIVERABLES

• Enable achievement of strategic business objectives.
• Regulatory cluster roadmap definition and implementation.
• Management of all regulatory activities.
• Ensure compliance to all regulations related to our business (products, allegations, communication claims).
• Management of Category Compliance activities.
• Manage registration SN portfolio.
• Prepare for and participate in internal & external audits.
• Follow action plan of audits.  
• Participate in local trade association.

 FUNCTIONAL COMPETENCIES:

• Regulatory knowledge: Regulations relating to infant and young child feeding; Regulations relating to labelling and advertising of foodstuff; Regulations relating to composition of foodstuffs; Regulations on medical device; Pharmaceutical Regulation
• Knowledge of health sciences and nutrition
• Advocacy competencies
• Management & leadership competencies: Ability to prioritise and lead action plans with pragmatism; Agility, and ability to manage complexity; Take decisions while assuming associated risks; Develop clear & efficient recommendations
• Business Acumen: Collaborative mindset & attitudes; Ability to develop networks internally and externally; Strong communication and negotiation skills; Leadership and embedding capacity including with top management; Internal and external impact and influence; Strategic vision; Ability to provide clear presentation; Be proactive

SOFT SKILLS:

• Strong organising skills, rigor
• Displays resilience and determination while showing flexibility & calm
• Attention to detail & accuracy
• Autonomy
• Interpersonal skills
• Ability to work across functions and building effective working relationships between functions
• Communication skills - verbal, written, presentation
• Fluent in English (written and verbal); French is a plus

REQUIRED EXPERIENCE

           5 – 7 years in infant feeding, specialised nutrition, health or pharmaceutical industries with demonstrated experience in category compliance and regulatory affairs management. 

EDUCATIONAL REQUIREMENTS:

•            Bachelor of Science Degree with Higher National Diploma or equivalent qualification in health sciences.
•            Regulatory expertise.
•            Scientific knowledge.
•            Management experience.
•            Dietitian, Doctor, Pharmacist or equivalent registered with Health Professions Council of South Africa (HPCSA).