Senior Regulatory Affairs Pharmacist
Senior Regulatory Affairs Pharmacist
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1 Vacancy
Job Description
At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.
The Position
A healthier future. Its what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come.
Creating a world where we all have more time with the people we love.
Thats what makes us Roche.
The Opportunity
Make your mark. Improve lives.
Join our team in Roche Pharma as a Senior Regulatory Affairs Pharmacist!
As a Senior Regulatory Affairs Pharmacist 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.
Your Key Activities will Include:
Providing advice on submitting dossiers/new indications and ensuring registration by the health authorities in the shortest possible time
Ensuring maintenance of dossiers in accordance with company directives SOPs and legislative requirements and that Roche pharma complies with all aspects of local legislation and internal guidelines relating to medicines and pharmacy practices
Ensuring product registration portfolio reflects the business needs and objectives in line with market trends and developments
Assisting with the approval of advertising and packaging materials ensuring that these are in line with the legal requirements
Providing advice and guidance to relevant departments regarding local medicine pharmacy legislation and pharmacy practice internal guidelines directives and SOPs
Establishing and maintaining relationships with key external market stakeholders (eg IPASA MRA/SAHPRA)
Who You Are as an Ideal Candidate
You are someone who wants to influence your own development. You are 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:
Pharmacy Degree (BPharm)
Previous Pharma experience 57 years and exposure to Regulatory Affairs would be advantageous
Demonstrate knowledge of and ability to interpret all related medicines legislation and guidelines
Ability to prioritise and analyse detailed information
Excellent communication written and oral skills
Good interpersonal skills and stakeholder collaboration across all levels
Excellent networking skills
Ability to work independently and within teams
Ability to abide by values and procedures that reflect organisational and professional norms.
Demonstrated computer literacy in PowerPoint at intermediate level and excel at basic level
Supervisory experience will be an added advantage.
Note that a full job description is available upon request.
Who we are
A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver lifechanging healthcare solutions that make a global impact.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Required Experience:
Senior IC
Employment Type
Full-Time
