Regulatory Affairs Pharmacist (Contract Position)
This is a contractual position for 1 year to contribute for new submission and maintenance of business for the RSA region. Products include OTC, health supplements, cosmetic, food, medicinal and non-medicinal categories.
- To drive new product registration strategy for launch, write, review and compile technical dossier for RSA region along with tracking of submission and approvals.
- To deliver duties as Deputy Responsible Pharmacist of Procter & Gamble South African Trading (Pty) Ltd in the absence of the Responsible Pharmacist (If required)
- To lead post approval change strategy, dossier writing, compilation, review and timely submission / notification with Board of health. Track the submission / approvals.
- Actively participate in base initiative, commercial initiative, regulatory compliance projects, remediation activities, MAH cancellation and divestment projects and due diligence.
- To timely respond to Health authorities questions by co- coordinating with stakeholders.
- Co-ordinate with SAHPRA, SPAC, DoH and other external bodies for ensuring smooth regulatory activities and regulatory intelligence.
- To work seamlessly with regional regulatory team for projects, best practice guide,SOP, project strategy, working instruction etc.
- To ensure completion of all relevant trainings(regional / global and country specific) WI, CBA, SOP.
- To contribute for writing Work Instruction (WI), Best Practice Guide, SOP (if applicable)
- Co-ordinate with different stakeholders for regulatory activities related with advertisement, packaging, labelling. Ensure submission of regulatory package inline with current regulation in force.
- To ensure administrative activities
- To upload product regulatory document / information.
- To review and approve artwork and marketing promotional material.
- Develop and maintain thorough and up-to-date understanding of the RSA regulatory environment and provide early input to BU functions and suggest an adequate regulatory path to conform to expected requirements.
- Develop and implement regulatory strategies to support the registration and marketing of global / regional and local brands.
Management of Regulatory operations in the countries:
- Management of all regulatory and development projects relevant to the RSA business / region.
- Prepare regulatory strategy and regulatory documents for RSA markets according to the RA Work Plan (WP).
- Monitor, collect and interpret regulatory guidelines and trends that will impact marketed and to be submitted products, share this information with appropriate regional BU and RA functions and assist in the development of strategies and plans of action to address them.
- Provide advice and training on regulatory requirements and compliance to the local business, IRA, and Global RA (Regulatory Intelligence group)
Qualifications & Experience Needed:
- UniversityDegreeinMedicine/Pharmacy/Sciencewithaminimumof7yearsofregulatoryexperience. ExperienceinmanagingRSAmarketsispreferred.
- Opennessto changeandabilitytothinkoutofthebox.
About Procter & Gamble:
For over 180 years, P&G has created some of the world’s most successful brands, including Ariel®, Tide®, Pantene®, Pampers®, and Gillette®. We believe in serving the consumer and ensuring our organization, talent and brand building reflects the diversity and needs of the approximate 5 billion people around the world we serve through our brands. We value leadership as well as mastery and offer fulfilling career opportunities that make us an unbeatable force in our industry.
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