8 Jun '21
Regulatory Affairs Lead

Medical, Gauteng Gauteng

market - related

A Global FMCG Company has a vacancy for a Regulatory Affairs Lead.

Job Purpose:

  • Responsible for the South Africa market registration/regulatory activities within the Business Unit. Key objectives of the position include but not limited to:
  • To ensure compliance across the portfolio
  • To work collaboratively with internal stakeholders (Global and local regulatory affairs and other cross functional teams) to generate and implement the regulatory strategy to secure and maintain marketing authorisations for the product across the area of responsibilities
  • To monitor, collect, and interpret changes in the external regulatory environment

Key Responsibilities:

  • Ensure development, communication and implementation regulatory strategies that enable the delivery of a pipeline of product innovation to meet the South Africa strategies for the category segment(s).
  • Ensure the regulatory environment is monitored and interpret regulatory matters and trends that could potentially impact products, policies and procedures are communicated early to the internal relevant stakeholders.
  • Interface with regulatory authorities and industry associations in South Africa to assess the impact and implementation of required company compliance with all regulations, laws and industry policies that affect the ingredients, packaging, marketing, advertising, labeling and production for their products.
  • Advise Global Category Development and regional Scientific Services and business personnel on regulatory requirements and regulatory impact during the early phases of the NPD process
  • Provide regulatory and product expertise in the development and clearance of advertising and label copy for existing and NPD/EPD
  • Ensure that updated and compliant Material and Product Safety Data Sheets (PSDS) exist for all products
  • Ensure the required dossier updates are executed at appropriate, regular intervals, in line with regulatory and internal standards.

Requirements:

  • B. Pharmacy or Equivalent
  • Experience within Regulatory Affairs is imperative (Minimum 5 years)
  • Ability to understand and interpret directives and regulatory guidelines and communicate them effectively to the relevant stakeholders.
  • Proven ability to work under pressure without compromising on deliverables
  • Experience with management and development of people

Competencies:

  • Detail orientated
  • Results oriented, entrepreneurial and self-motivating
  • Bias for action, capability to define, evaluate and take risks
  • Strong leadership, motivational and interpersonal skills
  • Capable of building strong working relationships and motivating teams to deliver outstanding results with or without hierarchical relationships.
  • Commercial understanding of corporate and operational business matters.
  • Strong understanding of marketing strategy, priority setting, project management
  • Ability to transform solid thinking into action (a thinker and an achiever)
  • Excellent communication skills both written and oral (in English)
  • Appetite for exploring new and previously uncharted territories
  • Openness to change and ability to think out of the box
  • Good presentation skills
  • Well-developed Influencing and persuasive skills

 

Candidates that meet the criteria may submit their applications via this portal or via vacancy link on www.mnarecruitment.com

Should you receive no feedback within 7 days, please accept your application as unsuccessful.

 



 



 

 

Ad Visible Until: 30 July 2021
Ref: DBN002910/SS

Vacancy Type: Permanent