Website Human Accent
Human Accent is part of The Accent Group, where our purpose is to create a world where everyone wins. We are guided by a set of unwavering values that drive our actions and enable us to make a positive impact on individuals, organisations, and communities alike. At… read more the heart of our endeavours lie our core values—Bravery, Curiosity, Connection, Building, and Compassion—serving as the bedrock of our commitment to excellence and compassion in everything we do. Human Accent stands tall as a premier Talent Search and Management Consultancy. We possess an unwavering focus on unlocking the true potential of the talent in your business. We are talent hunters guided by meticulous attention and innovative approaches. We specialise in the end to end management of the talent life cycle from talent acquisition, talent assessment and mapping, succession, development plans to talent analytics needed to measure real success.
Main Purpose of Job
To fulfil the position of regulatory affairs pharmacist within any division within the group.
Key Performance Areas (Core, essential responsibilities –outputs of the position)
Responsible for new product applications.
Compilation and submission of Post –Registration amendments to ensure dossier compliance.
Responsible for pre and post-registration SAHPRA Committee recommendation responses to ensure product registration.
Responsible for dossier updates, PI/PIL updates to ensure compliance with current legislation
To ensure approval and compliance of printed packaging material and promotional marketing material.
Liaising with the marketing department to facilitate the timely launch of products.
Approval of master batch documentation prior to product production.
Responsible for SOP implementation/review, update and compliance.
Managing and maintaining the regulatory documentation filing system.
Ensuring regulatory compliance and quality-related records are available and retained.
Ensure ongoing regulatory compliance of the existing product portfolio.
Ensure awareness of legislative changes and trends that will impact the core function of the regulatory affairs department and hence the marketability of company products
Liaise with business development for regulatory requirements prior to dossier acquisition.
Training and peer review of documents
Minimum Requirements
EDUCATION
Bachelor of Pharmacy Degree
EXPERIENCE
Minimum 2 years’ experience in regulatory affairs in any regulated regions e.g., South Africa Europe, UK, Australia, Canada, Japan
SKILLS/PHYSICAL COMPETENCIES
Docubridge
Sage
Smartsheet
Sweet process
Microsoft: Excel, Word, PowerPoint, Outlook
BEHAVIOURAL QUALITIES
Takes ownership.
Integrity, bound to principles, confidentiality, and ethics.
Strong leadership skills.
Good communication skills.
Good organisational skills.
Good planning skills.
Good follow-up skills
Attention to detail
Assertive.
Conscientious.
Patient.
Co-operative.
Deadline Driven
DESIRABLE SKILLS & EXPERIENCE:
2 Years’ experience in regulatory affairs and attention to detail
Collaboration: Refers to formal and informal relationships.
Responsibility towards:
Responsible Pharmacist
Procurement
Marketing
NBD
Apply via company website ( https://humanaccent.co.za/who-we-are/ ) or
humanaccent.simplify.hr
To apply for this job please visit humanaccent.simplify.hr.