Regulatory Affairs Operations Lead
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Job Location:
Midrand - South Africa
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
A pharmaceutical client is looking for a Regulatory Affairs Operations (RegOps) Lead that will responsible for overseeing Regulatory Operations activities and strategic initiatives in support of pre- and post-approval filing as well as ongoing document maintenance efforts within their OTC division.
Qualifications
Experience
Core competencies
- Pharmacy Bachelors degree or equivalent in life sciences or technology-related discipline
- Grade 12
Experience
- Minimum 2 years Regulatory Operations experience required.
- 5 years pharmaceutical industry experience with prior Regulatory Operations experience required.
- Experience leading the management of projects/timelines and collaborating with team members
- Expertise in the use of a document management eCTD format and regulatory submission requirements and eCTD publishing systems
- Advanced technical skills in best business practices for electronic regulatory document preparation and submission and document and life cycle management systems
- Previous experience developing work instructions and generating SOPs that are consistent with health authority requirements and company business practices
- Proven ability to manage streamline and collaborate to improve document preparation and management systems
Core competencies
- Advanced technical skills in best business practices for electronic regulatory document preparation and submission and document and life cycle management systems
- Excellent negotiation and relationship development skills to effectively interact with vendors and partners
- Demonstrated advanced leadership problem solving and organizational skills
- Excellent oral and written communication skills
- An ability to be productive and successful in an intense work environment
- Knowledge of industry trends regarding electronic submissions.
- Technical knowledge of electronic publishing systems and software.
- Proficiency with MS-Office Suite and Adobe Acrobat application
- Must demonstrate responsibility excellence and collaboration and align with Company values
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
