Regulatory Affairs Pharmacist

1 week ago

Midrand, South Africa Cipla Full time

**Division**

Integrated Product Development

**Department**

Regulatory Affairs

**Employment Type**

Permanent

**Job Purpose**

Support the Regulatory Affairs function in its pre-registration and/or post-registration dossier submission activities by assisting in data gathering, screening, collating and compiling of the dossiers, post-registration variations and any other documentation in order to submit the same to the Health Authorities for approval within the defined timelines as per overall objective of Cipla Medpro.

**Accountabilities**

**1. CDT/New dossier submissions and approvals** - **Perform pre-launch activities to ensure timeous submission and registration of products within the defined timelines.**
- Completes dossier audits/due diligences and Regulatory Affairs (RA) strategies as required.
- Complete specific pre-registration activities including receipt, screening, compilation and timeous submission of new dossiers, P&A, Clinical and Naming & Scheduling responses to the Relevant Health Authority in line with the latest regulatory guidelines and in accordance with specific timelines committed to.
- Abide by the required standards, protocols and processes around obtaining dossiers and gathering supporting data from third party holders after signing of supply / purchase / financial agreements.
- Complete any required internal due diligences and risk reports to determine gaps ahead of time, and ensure that proper steps are taken, to proactively solve challenges in the registration process. This will ensure no delay at launch stage.
- Prepare new dossier submissions in paper and/or e-CTD systems, as required.
- Ensures timely identification of Regulatory Intelligence (RI) and appropriate impact assessment for RA and impacted departments as required. (Refer to point 5 section IV)

**2. Dossier Life Cycle Management
- **Perform the dossier life cycle management activities by supporting the post registration variations and other activities to ensure support to the regulatory function and its objectives**
- Receive, prepare and submit all applicable updates, variations, resolutions and any other correspondence required by the SAHPRA or any other applicable regulatory authority to ensure timely delivery and as per the defined standards.
- Prepare variations in paper and/or e-CTD systems, as required.
- Conduct dossier due-diligence in support of New Business Development projects.
- Support all new product launches/re-launches, which includes (but not limited to): Conducting dossier gap analysis to identify changes, artwork development, review and approval of artwork, variation preparations and submissions.
- Conduct any applicable telephonic communication with SAHPRA or any other regulatory authority as part of follow up on a timely basis
- Preparing post-registration updates to professional information and patient information leaflets.
- Implementing any changes in regulations and advising the applicable business units.
- Review and approval of all product artwork, in accordance with current Health Authority regulations and standards.
- Review and approval of change control documents, as and when required.
- Support the Quality Assurance teams from the various manufacturing Units with Annual Product Quality Review (APQR) requests/queries

**3. **Support and assist the administrative team in the responsibility to effectively manage and maintain dossiers (electronically and hard copies), collection and delivery of documents, ensure smooth operations and maintain quality standards**
- Ensure that the Document Database is kept up to date by completing the required administration activities for appropriate maintenance, co-ordination and accuracy of all dossiers and correspondence
- Ensure correct photocopying, binding, and final preparation of documents (for submission purposes and the in-house copy) including the quality check is timeously done before final submission to the applicable Health Authority.
- Complete any internal risk reports in line with the above submissions in order to avoid rejections / comebacks from any health authority.
- Delivery and collection of documents from the Health Authority when necessary

**4. **Develop and manage stakeholder relationships by communicating and interacting on a regular basis in order to achieve the functional objectives**
- Align and collaborate with relevant Cipla India based stakeholders, local stakeholders and third-party suppliers to ensure compliant, good quality dossiers are received to submit it to the Health Authorities.
- Build and maintain relationships with all external stakeholders, including 3rd party principals, industry bodies and consultants.
- Keeping abreast of developments and changes in the local regulatory and international environment which directly impacts Cipla products. Effectively communicating these changes to all relevant stakeholders to assess the impact on the business.

**Educational Qualifications**

Bachelor of Pharmacy D

  • Regulatory Affairs Pharmacist

    3 months ago

    Midrand, South Africa Jobted ZA C2 Full time

    Regulatory Affairs Pharmacist (OTC) POS24328 Area: Midrand Salary R900 R1m Qualifications - Bachelors 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...

  • Regulatory Affairs Pharmacist Specialist

    2 weeks ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Emporium Human Capital. As a key member of our organization, you will be responsible for managing work streams and ensuring regulatory compliance across various product development stages.

  • Regulatory Affairs Pharmacist Specialist

    2 weeks ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job DescriptionThis is a senior Regulatory Affairs role for a Regulatory Affairs Pharmacist Specialist to manage regulatory activities for pharmaceutical products. The successful candidate will be responsible for ensuring compliance with relevant regulations and guidelines.Main ResponsibilitiesManage work streams for- and report on the assigned portfolio of...

  • Regulatory Affairs Pharmacist

    4 months ago

    Midrand, South Africa Emporium Human Capital Full time

    Regulatory Affairs Pharmacist (OTC) POS24328 Area : Midrand Salary R900 R1m Qualifications Bachelors 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...

  • Regulatory Affairs Pharmacist

    4 months ago

    Midrand, South Africa Emporium Human Capital Full time

    Regulatory Affairs Pharmacist (OTC) POS24328Area: MidrandSalary R900 R1mQualificationsBachelors 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...

  • Regulatory Affairs Pharmacist: OTC Job Opportunity

    2 days ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Emporium Human Capital is seeking a highly skilled Regulatory Affairs Pharmacist to join their team in Midrand. The ideal candidate will have a Bachelor's Degree in Pharmacy and at least 5 years of experience in regulatory affairs, preferably in human medicines, including complementary medicines and medical devices.About the RoleThis is an exciting...

  • Regulatory Affairs Pharmacist Lead

    12 hours ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job DescriptionWe are seeking a highly skilled Regulatory Affairs Pharmacist Lead to join our team at Emporium Human Capital.In this role, you will be responsible for managing work streams and reporting on assigned portfolios of products. You will establish regulatory priorities, allocate resources, and workloads, while ensuring compliance with regulatory...

  • Regulatory Affairs Manager

    7 months ago

    Midrand, South Africa Cipla Full time

    **Department**: Regulatory Affairs **Employment Type**: Full-time **Job Purpose**: - Manage submissions to different Health Authorities within the Regulatory Affairs function by ensuring targets are met each financial year - Manage registrations and engagement with the different Health Authorities to ensure targets are met w.r.t. registrations and...

  • Regulatory Affairs Pharmacist

    3 months ago

    Midrand, South Africa Jobted ZA C2 Full time

    Regulatory Affairs Pharmacist OTC POS24203 Based: Midrand Salary: R750K Qualifications/experience - Bachelors degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council - 3 to 5 years experience in Regulatory Affairs, preferably in human medicines - Demonstrable experience across the product development,...

  • Regulatory Affairs Manager

    3 weeks ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    **Regulatory Affairs Specialist Wanted!We're Emporium Human Capital, a leading recruitment agency in South Africa, and we're looking for an experienced Regulatory Affairs Pharmacist to join our team!**About the Job:This is a fantastic opportunity to utilize your expertise in Regulatory Affairs to drive business success.You'll develop and implement regulatory...

  • Regulatory Affairs Pharmacist Expert

    1 month ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Emporium Human Capital. This is an exciting opportunity for a motivated and experienced professional to take on a key role in ensuring the compliance and registration of pharmaceutical products.About the RoleThis position involves managing work streams, reviewing...

  • Senior Regulatory Affairs Pharmacist

    3 weeks ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job Summary   Emporium Human Capital is seeking a highly skilled Senior Regulatory Affairs Pharmacist to join our team. The ideal candidate will have experience in regulatory affairs, preferably in human medicines, including complementary medicines and medical devices.   Key Responsibilities:   Manage work streams for- and report on the assigned...

  • Regulatory Affairs Pharmacist

    3 months ago

    Midrand, South Africa Jobted ZA C2 Full time

    Regulatory Affairs Pharmacist (CAM) POS2432 Area: Midrand Salary R900 R1m Division: Complimentary Medicine Qualifications - Bachelors 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...

  • Regulatory Affairs Specialist

    3 weeks ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Emporium Human Capital.

  • Regulatory Affairs Pharmacist for Human and Complimentary Medicines

    2 weeks ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job Overview:We are seeking a seasoned Regulatory Affairs Pharmacist to join our team at Emporium Human Capital. This role will be responsible for managing work streams, reporting on assigned portfolios, and ensuring regulatory compliance across human medicines and complimentary medicines.Key Responsibilities:Manage internal product queries from relevant...

  • Regulatory Affairs Pharmacist

    1 month ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job OverviewWe are seeking an experienced Regulatory Affairs Pharmacist to join our team at Emporium Human Capital. As a key member of our pharmaceutical compliance team, you will play a critical role in ensuring the registration and maintenance of our products in accordance with regulatory requirements.About the RoleThis is an exciting opportunity for a...

  • Senior Regulatory Pharmacist

    3 weeks ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    We are looking for a Senior Regulatory Pharmacist to lead our regulatory affairs team in Midrand. The successful candidate will have a minimum of 5 years of experience in regulatory affairs and a strong understanding of pharmaceutical production and Good Manufacturing Practices (GMP).The ideal candidate will be responsible for conducting dossier due...

  • Regulatory Affairs Pharmacist

    7 months ago

    Midrand, South Africa Emporium Human Capital Full time

    Regulatory Affairs Pharmacist OTC POS24203 Based : Midrand Salary : R750K Qualifications/experience Bachelors degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council 3 to 5 years experience in Regulatory Affairs, preferably in human medicines Demonstrable experience across the product development, commercialization...

  • Regulatory Affairs Pharmacist

    4 days ago

    Midrand, South Africa MSD Full time

    Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the...

  • Regulatory Affairs Pharmacist

    1 month ago

    Midrand, South Africa Cipla Full time

    **Division**: Regulatory Affairs **Department**: Regulatory Affairs **Employment Type**: Permanent **Job Purpose**: Support the Regulatory Affairs function in its pre-registration and/or post-registration dossier submission activities by assisting in data gathering, screening, collating and compiling of the dossiers, post-registration variations and any...