Senior Regulatory Affairs Pharmacists

7 months ago

Johannesburg, South Africa Unique Personnel Full time

**Job Number**
- 72990

**Job Type**
- Permanent

**Job Title**
- Senior Regulatory Affairs Pharmacists

**Computer Skills**
- Mcrosoft Office

**Industry**
- Manufacture

**City**
- Johannesburg (Incl. Northern Suburbs)

**Province**
- Gauteng

**Reporting to Regulatory Affairs Manager**

**Job purpose**:

- Support the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external Partners and Principals, and to control and manage a portfolio of product outputs.

**Key Job Outputs**
- Manage work streams for
- and report on the assigned portfolio of products:

- Internal product queries from relevant departments
- External product queries from the SAHPRA, other MRA’s and third party stakeholders
- Establish regulatory priorities and allocate resources and workloads
- Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards
- Develop regulatory strategies and implementation plans for the preparation and submission of new products, with a focus on complementary medicines and medical devices.
- Conduct dossier due diligence to ensure all data gaps are addressed, in preparation for dossier call up and registration of complementary medicines and other human medicines.
- Work in collaboration with internal and external stakeholders to assess regulator’s submissions requirements
- Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines for variations (CMC & Labelling), Renewals, Artwork updates etc.
- Update and maintain databases, trackers and systems for all regulatory related activities.
- Quality Management System: Comply with all requirements of Quality Management System to ensure Good Regulatory Practices are maintained.
- Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
- Internal training and mentoring of peers when required.
- Establish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders
- Formulate or implement regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Support activities such as internal audits or regulatory agency inspections
- Ensure alignment of personal and company values**Inherent Requirements**

**Qualifications/Experience**
- Bachelor’s Degree in Pharmacy. Diploma in Pharmacy and Registration with the South African Pharmacy Council
- +-5 years’ experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices for end-to-end regulatory activities.
- Demonstrable experience across the product development, commercialization and maintenance lifecycle
- Sound project management capabilities
- Proven ability to consistently deliver to quality, time and cost standards
- Good Manufacturing Practices (GMP)
- Pharmaceutical production experience or exposure to supplement regulatory knowledge.

**Core Competencies**
- IT skills including Microsoft Office
- Ability to prioritise and work to tight deadlines
- Systems and operations analysis
- Basic cost management skills
- Active learning
- Strategic thinking
- Ability to cope with a high degree of complexity and change
- Cross Functional skills: Ability to network, liaise and negotiate with others
- Ability to set standards and objectives and monitor progress
- Complex problem solving and decision-making skills
- Customer relationships
- Development of people
- Must demonstrate responsibility, excellence and collaboration and align with Company values

**What Qualification**
- Pharmacy

**Minimum Qualification**
- Bachelors

**Status**
- Available

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