Head of Regulatory Affairs, Responsible Pharmacist

2 weeks ago

Johannesburg, South Africa ARIAD Full time

**Head of Regulatory Affairs, Responsible Pharmacist**:
Johannesburg, Gauteng

**Job ID** R0118346

**Category** Research & Development

**Subcategory** Research & Development

**Business Unit** Global Portfolio Division

**Job Type** Full time
- Title:_ Head of Regulatory Affairs, Responsible Pharmacist
- Location:_**_Johannesburg, South Africa_**_office._
- Field: Regulatory and Quality_

**About Takeda**

At Takeda we strive to broaden access to treatment and enhance standards of care for people wherever they live. We focus on sustainably strengthening local health systems in low
- and middle-income countries at every stage of the patient journey, while developing an end-to-end access approach to make our highly innovative medicines available as soon as practically possible.

Takeda is unwavering in our commitment to patients. With the patient at the center of everything we do, we continue to innovate and drive changes that will better their lives and we are looking for like-minded professionals to join us.

**Who we are looking for**:
We are currently looking for a strong healthcare profile with the right attitude to join our Regulatory team in the role of Head of Regulatory Affairs, Responsible Pharmacist.

**Objectives of this role**:

- Prepare and execute optimal regulatory strategies aimed to deliver product approvals and/or life cycle management in accordance with the regulatory objectives of the regional business.
- Ensure compliance with legislation in terms of the Medicines Act 101 of 1965; Pharmacy Act 53 of 1974 and GMP/PIC/WHO guidelines controlling medicines, and pharmaceuticals in South Africa, Sub Saharan Africa (SSA) and relevant territories.
- Provides strategic guidance on both the SA/SSA regulatory strategy and Quality issues aligned with portfolio segmentation and unmet need.
- Secure dossiers for timely registration aligned with LOC business strategy, building long-term relationships with regulators, responding on time to feedback, collaborating with local and global partners, aligning on requests ensuring global position on medicines for registration
- Lead the regulatory and quality team, building skills and capabilities to ensure optimal performance while representing the LOC on regional/ global and external forums.

**Required qualifications and experience**:

- Pharmacy /Science degree required. Higher level pharmaceutical degree, MBA and/or post graduate education in health science or health economics is an advantage
- 7-10 years regulatory experience regulatory affairs and/or drug development. Experience in development and registrations of biotech product will be an advantage.
- Excellent working knowledge of pharmaceutical regulations as they relate to the region of responsibility.
- Working experience within Southern Africa, relevant knowledge of international regions is an advantage

**Accountabilities**:
Head of Regulatory
- In collaboration with global/regional/area Regulatory strategy; provide regulatory strategies to responsible functional groups and regulatory management in SA and SSA.
- Support Quality team in preparing and maintaining project plans, identify opportunities for improvement aligned with specialty care product portfolio.
- Ensure appropriate evaluation of local business and regulatory registration requirements for investigational and marketed products and prepare regulatory assessment reports as needed.
- Monitoring reporting and setting timelines for the variations, renewals, and pharmacovigilance related activities databases.
- Initiating the process for Health Authority approved packaging materials for defined therapeutic areas of responsibility, providing full regulatory support.
- Ensure compliance of regulatory and quality activities in Southern Africa consistent with Country legislation and Takeda internal protocols and procedures.
- Provide guidance/advice on global/regional/area regulatory environments and provide assessment of the impact of new and changing regulations/requirements.
- Build capabilities ensuring development of regulatory team through regular coaching, mentoring and team IDP’s.
- Audit and Regulatory Compliance:

- Ensure that business under control is meeting desired compliance levels
- Support the Quality Management System with set-up, alignment, and implementation of SOPs

Responsible Pharmacist (SA)
- Responsibilities in terms of the Medicines and Related Substances Act:

- Selling of unregistered medicines (Section 21) and the prohibition on the sale of certain medicines; sale of medicines to authorized persons;
- Labeling and advertising of medicines (Section 18).
- Understanding of, Medicines Medicines Act 101 of 1965, including transparent pricing of medicines (Section 18A, 18B & 18C and section 36 ).
- Licensing (Section 22C).
- Disposal of medicines (Section 23).
- Responsibilities in terms of the Pharmacy Act
- Any act performed by or on behalf of the management of the business (Section 22)
- Duties in terms of Reg

  • Head of Regulatory Affairs

    3 days ago

    Johannesburg, South Africa Acino Full time

    Acino values courage, commitment, trust, and empathy and provides an environment that supports initiative and effort. With our ‘hands-on’ mentality, short communication channels and quick decision-making we deliver sustainable results for our customers, partners and employees. With passion, commitment and dedication, the role you start with at Acino will...

  • Regulatory Affairs Pharmacist

    4 weeks ago

    Johannesburg, South Africa Unique Personnel Full time

    **Job Number** - 72989 **Job Type** - Permanent **Job Title** - Regulatory Affairs Pharmacist **Computer Skills** - Ms Office **Industry** - Manufacture **City** - Johannesburg (Incl. Northern Suburbs) **Province** - Gauteng - Reporting To Regulatory Affairs Manager / Senior RA Pharmacist**Job Purpose** - To Support the Regulatory Affairs team with...

  • Regulatory Affairs Pharmacist

    4 weeks ago

    Johannesburg, South Africa Unique Personnel Full time

    **Job Number** - 72787 **Job Type** - Permanent **Job Title** - Regulatory Affairs Pharmacist **Computer Skills** - Ms Office **Industry** - Manufacture **City** - Johannesburg (Incl. Northern Suburbs) **Province** - Gauteng - Reporting To Regulatory Affairs Manager / Senior RA Pharmacist**Job Purpose** - To Support the Regulatory Affairs team with...

  • Regulatory Affairs Pharmacist

    1 month ago

    Johannesburg, South Africa JorDan Human Resources Full time

    2024-01-23 - 2024-02-06 - Permanent - CT004178 - Medical, Pharmaceutical & Nursing- Gauteng, JHB - Northern Suburbs - R 55000 - R 58000 Monthly Cost To Company (Standard Benefits )- Pharmaceutical Production Client in JHB North in need of a Regulatory Affairs Pharmacist, to ensure legal compliance with the relevant Medicine Regulatory Authorities (Country...

  • Regulatory Affairs Pharmacist

    4 weeks ago

    Johannesburg, South Africa JorDan Human Resources Full time

    2024-04-19 - 2024-05-03 - Permanent - CT004296 - Medical, Pharmaceutical & Nursing- Gauteng, JHB - Northern Suburbs - R 65000 - R 70000 Monthly Cost To Company (Standard Benefits )- Pharmaceutical Production Client in JHB North in need of a Regulatory Affairs Pharmacist, to ensure legal compliance with the relevant Medicine Regulatory Authorities (Country...

  • Regulatory Affairs Pharmacist

    4 weeks ago

    Johannesburg, South Africa Unique Personnel Full time

    **Job Number** - 71064 **Job Type** - Permanent **Job Title** - Regulatory Affairs Pharmacist **Computer Skills** - Adobe Acrobat,MS Excel **Industry** - Manufacture **City** - Johannesburg **Province** - Gauteng - Reporting to RA Systems Manager**Job purpose** - Maintain applicable regulatory affairs information management electronic systems, ensuring...

  • Senior Regulatory Affairs Pharmacist

    4 weeks ago

    Johannesburg, South Africa PSM Personnel Full time

    Senior Regulatory Affairs Pharmacist Pharmacist ~ Regulatory Johannesburg North-Gauteng Qualifications/experience - Bachelors Degree or Diploma in Pharmacy with the South African Pharmacy Council registration. - +-5 years experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices for end-to-end...

  • Regulatory Affairs Pharmacist

    4 weeks ago

    Johannesburg, South Africa JorDan Human Resources Full time

    2023-01-27 - 2023-02-17 Permanent JHB006833 Medical, Pharmaceutical & Nursing Gauteng, JHB - Eastern Suburbs R 1000000 - R 1100000 Annually Basic Salary Leading Pharmaceutical Company on East Rand seeking RA Pharmacist - Lead, manage, execute and provide strategic direction as the regulatory affairs pharmacist - Provide oversight for assigned countries...

  • Junior Regulatory Affairs Pharmacist

    1 month ago

    Johannesburg, South Africa Unique Personnel Full time

    **Job Number** - 72214 **Job Type** - Permanent **Job Title** - Junior Regulatory Affairs Pharmacist **Computer Skills** - Ms Office **Industry** - Manufacture **City** - Johannesburg (Incl. Northern Suburbs) **Province** - Gauteng - Reporting To Regulatory Affairs Manager / Senior RA Pharmacist**Job Purpose** - Entry Level position to Support the...

  • Regulatory Affairs

    1 month ago

    Johannesburg, South Africa Mass Staffing Projects Full time

    **Job Information** - Location- Manufacturing Jobs in Johannesburg- Salary- R940k - R720k- Job Type- Permanent- Education- B.Pharm- Experience- 3+ Years- Reference- RAPHARM9- - pharmacy.jobs(at)staffingprojects.co.za- Fax- 0866023398MSP Recruitment is currently recruiting for a Multinational Pharmaceutical organisation based in Johannesburg, who seeks to...

  • Junior Regulatory Affairs Pharmacist

    1 month ago

    Johannesburg, South Africa JorDan Human Resources Full time

    2024-01-23 - 2024-02-06 - Permanent - CT004179 - Medical, Pharmaceutical & Nursing- Gauteng, JHB - Northern Suburbs - R 40000 - R 41000 Monthly Cost To Company (Standard Benefits )- Pharmaceutical manufacturing client in JHB north in need of a Junior Regulatory Pharmacist, to ensure compliant and timeous processing of regulatory submissions and prioritise...

  • Snr Regulatory Affairs Pharmacist

    4 weeks ago

    Johannesburg, South Africa Servier Full time

    . Servier Laboratories Snr Regulatory Affairs Pharmacist JOB OVERVIEW: As a Snr Regulatory Affairs Pharmacist your responsibility for ensuring thorough, seamless product registration process and dossier maintenance. Ensuring that the company complies with all regulations and maintain Servier’s pharmacovigilance requirements. DUTIES AND...

  • Snr Regulatory Affairs Pharmacist

    1 week ago

    Johannesburg, South Africa Hire Resolve Full time

    Hire Resolve is seeking a Senior Regulatory Affairs Pharmacist to join our client's team. As a Senior Regulatory Affairs Pharmacist, you will be responsible for ensuring compliance with regulatory requirements and managing the registration of pharmaceutical products.Responsibilities Prepare and submit regulatory applications for the registration of...

  • Regulatory affairs pharmacist

    1 month ago

    Johannesburg, South Africa Curiska (Pty) Ltd Full time

    JOB OVERVIEW:Ensuring thorough, seamless product registration process and dossier maintenance. Ensuring that the company complies with all regulations and maintain comapanys pharmacovigilance requirements.DUTIES AND RESPONSIBILITIES:• Provide, Lead, manage, and execute strategic direction as the regulatory affairs pharmacist• Ensure and supervise that...

  • Regulatory affairs pharmacist

    4 weeks ago

    Johannesburg, South Africa Curiska Full time

    JOB OVERVIEW:Ensuring thorough, seamless product registration process and dossier maintenance. Ensuring that the company complies with all regulations and maintain comapanys pharmacovigilance requirements.DUTIES AND RESPONSIBILITIES:• Provide, Lead, manage, and execute strategic direction as the regulatory affairs pharmacist• Ensure and supervise that...

  • Regulatory affairs pharmacist

    4 weeks ago

    Johannesburg, South Africa Adzuna ZA B C2 Full time

    JOB OVERVIEW:Ensuring thorough, seamless product registration process and dossier maintenance. Ensuring that the company complies with all regulations and maintain comapanys pharmacovigilance requirements.DUTIES AND RESPONSIBILITIES:• Provide, Lead, manage, and execute strategic direction as the regulatory affairs pharmacist• Ensure and supervise that...

  • Regulatory Affairs Pharmacist and Deputy

    4 weeks ago

    Johannesburg, South Africa AstraZeneca Full time

    Are you a Pharmacist with expertise in Regulatory Affairs working in a Pharmaceutical industry ? If so, AstraZeneca might be the one for you!_ **ABOUT ASTRAZENECA** AstraZeneca is a global, innovation-driven Biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most...

  • Senior Regulatory Affairs Pharmacists

    4 weeks 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...

  • Senior Regulatory Affairs Pharmacist

    1 month ago

    Johannesburg, South Africa Abbott Laboratories Full time

    **Senior regulatory Affairs Pharmacist - EAC** **About Abbott** Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. **Working at Abbott** At Abbott, you can do work that matters, grow, and learn, care for...

  • Regularity Affairs Pharmacist

    1 month ago

    Johannesburg, South Africa RPO Recruitment Full time

    RPO Recruitment is a trusted recruitment agency specializing in finding top talent in the field of regulatory affairs within the pharmaceutical industry. Our client, a leading pharmaceutical company, is seeking a Regulatory Affairs Pharmacist to join their team.As a Regulatory Affairs Pharmacist, you will play a vital role in ensuring compliance with...