- Entry level
- No Education
- Salary to negotiate
- SOUTH AFRICA - SOUTH AFRICA
Regulatory Affairs Manager
Illovo Johannesburg South Africa
Reports into: Head Medical Affairs
Who we are
At Roche, more than 91 700 people in over 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity, and on seeing each other’s differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing – and is seeking people who have the same goals for themselves.
Make your mark. Improve lives.
As Regulatory Affairs Manager, you will ensure the registration of medicines and obtain approval for new indications of products according to the business strategy, as well as the maintenance of current product dossiers so that the business is able to operate optimally at all times.
Your key activities will include:
Submission of dossiers/new indications and ensuring registration by the health authorities in the shortest possible time frame Ensuring maintenance of dossiers in accordance with company directives, SOP’s and legislative requirements and that Roche pharma complies with all aspects of local legislation and internal guidelines relating to medicines and pharmacy practices Align product registration portfolio to reflect the business needs and objectives, in line with market trends and developments and assisting with the approval of advertising and packaging materials Ensure compliance through management and update of all Regulatory policies and procedures and providing advice and guidance to relevant departments regarding local medicine pharmacy legislation and pharmacy practice, internal guidelines, directives and SOP’s Establishing and maintaining relationships with key external market stakeholders (e.g. IPASA, /SAHPRA) Fostering a high performing, engaged team who meet customer and business objectives
Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies, and where a job title is not considered the final definition of who you are, but the starting point.
This challenging role requires the following experience and skills:
Previous Pharma experience 7-10 years with exposure to Regulatory Affairs and 5 years’ management experience
Demonstrate knowledge of and ability to interpret all related medicines legislation and guidelines
Ability to prioritise and analyse detailed information with a keen sense of attention to detail and focus on results
Displays innovation and continuous improvement to simplify and improve processes to ensure better and faster outcomes for our patients
Excellent influential and networking skills with demonstrated stakeholder collaboration, strong agility and ability to manage change.
Excellent communication written and oral skills
Proven experience in building a successful team and fostering a transparent, trusting working environment with a focus on performance and career growth
Demonstrated computer literacy in PowerPoint at intermediate level and excel at basic level
The next step is yours.
About the company
Roche is a Swiss global health-care company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange.
The company headquarters are located in Basel and the company has many pharmaceutical and diagnostic sites around the world – including: Tucson, AZ; Pleasanton, CA; Vacaville, California, Oceanside, California, Branchburg, NJ; Indianapolis, Indiana; Florence, South Carolina; and Ponce, Puerto Rico in the US; Welwyn Garden City and Burgess Hill in the UK; Clarecastle in Ireland; Mannheim and Penzberg in Germany; Mississauga and Laval in Canada; Shanghai in China; Mumbai & Hyderabad in India; São Paulo and Rio de Janeiro, Brazil; Segrate, Milan in Italy; Johannesburg in South Africa; Karachi, Islamabad and Lahore in Pakistan. There are 26 manufacturing sites worldwide.