Regulatory Affairs Pharmacist/specialist:

1 week ago

Johannesburg, South Africa Takeda Pharmaceutical Full time

Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a **Regulatory Affairs Pharmacist/Specialist: (8-month Contract position) **in our **Johannesburg, South Africa** office.

Takeda is a global pharmaceutical leader with more than 50,000 professionals working together across 80 countries. We have an unwavering dedication to put people first and we live our values of **Takeda-ism**—Integrity, Fairness, Honesty, and Perseverance. We are united by our 240+ year legacy of research-based pharmaceuticals and our mission to strive toward **Better Health and a Brighter Future** for people worldwide through leading innovation in medicine.

Here, everyone matters, and you will be a vital contributor to our inspiring, bold mission.

**ROLE OBJECTIVES**:
The position will be responsible for,
- Product portfolio management of registered products and products under review for registration in South Africa (SA) and relevant export territories.
- Dossier maintenance - submission of variations in line with relevant regulatory requirements (country-specific and global requirements).
- Regulatory control and compliance over labelling, packaging, advertising and promotion of medicines

**REQUIRED QUALIFICATIONS AND EXPERIENCE**:

- BPharm degree, BSc science degree or equivalent.
- 2-3 years’ experience in the registration of medicines and submission of NCE.
- Valid SAPC registration would be an advantage
- Strong learning agility, ability and willingness to stretch self-acquiring new skills and competencies

**ACCOUNTABILITIES**:

- Manage regulatory process for specific area, this includes but is not limited to:

- Compile new product submissions specializing in NCE, CTD and electronic submissions
- Compile clinical dossier meeting the requirements of the Regulatory Authority (RA) in SA and relevant export territories, within the given timelines, to gain product registration.
- Complete due diligence checks and evaluation of prospective dossiers
- Assist in the regulatory arrangements needed to place new products on the market.
- Assist with regulatory follow-up to facilitate faster registration submission and obtain faster approval
- Liaise with and provide answers to queries on clinical matters connected to the products both with RA and with the International Principals
- Manage updates and maintenance of all registration dossiers to maintain product licenses in SA and relevant export territories
- Ensure variations and changes made to the registration dossier is properly controlled update the internal systems
- Liaise and represent Takeda with the RA in SA and relevant export territories
- Liaise with principal and international suppliers regarding registration /regulatory requirements and changing policies.
- Other general Regulatory work e.g. comment of proposed guidelines / legislative changes
- Exercise regulatory control over the labelling, advertising and promotion of medicines.
- Ensure that variations and changes made to the registration dossier are properly controlled and maintained.
- Compliance:

- Ensure compliance with the Approved Registration Dossier to meet specifications in each country (incl. export territories).
- Ensure compliance with all the Acts controlling medicines in SA and relevant export territories
- Training:

- Perform internal training on product related issues, where required
- Ensure Staff and /or Representatives are trained in terms of the Law and other applicable legislation applicable to the promotion and sale of medicines, where required
- Audit & Compliance
- Ensure that business under control is meeting desired compliance levels.
- Support the Quality Management system with the implementation of SOP’s

**BUSINESS SKILLS AND KNOWLEDGE**
- Excellent communication skills (verbal, written and presentation)
- Problem solving
- Sound judgment
- Good negotiation skills
- Proficient in MS Office
- Ability to establish and foster excellent customer relationships
- Planning and organising skills

**CORE COMPETENCIES**
- Foster trust
- Embraces Diversity
- Execute plans
- Propose solutions
- Promote change
- Be open and receptive
- Continually develop

**LICENSES/CERTIFICATIONS**:

- Valid South African Driver’s license for motor vehicle.
- Own vehicle that can be used for business.

**Empowering Our People to Shine**

Takeda is committed to providing a safe and healthy working environment and to having a workforce that is as diverse as the patients we serve and the communities where we’re based. To achieve that inclusivity, we embrace and celebrate our differences, respecting and valuing each other regardless of race, color, sex, age, national origin, religion, gender identity, sexual orientation, disability or physical appearance. We create a diverse, inclusive, safe, open and collaborative working environment in which employees can contribute, perform

  • Regulatory Affairs Pharmacist

    3 weeks ago

    Johannesburg, South Africa Unique Personnel Full time

    **Job Number** - 72665 **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

    2 weeks ago

    Johannesburg, South Africa MedicalCareers Full time

    A Pharmaceutical company has an opportunity for an experienced Regulatory Affairs pharmacist to join their team. Subordinates/ Direct Reports: Zero Main Purpose of Job To fulfil the position as regulatory affairs pharmacist for the company and any division within the group. Key Performance Areas (Core, essential responsibilities -outputs of the...

  • Regulatory Affairs Pharmacist

    2 days ago

    Johannesburg, Gauteng, South Africa MVG Recruitment Specialists Full time

    Regulatory Affairs PharmacistLarge pharmaceutical manufacturing facility seeks to employ a Regulatory Affairs Pharmacist. The following applies:Key Responsibilities:Ensure timeous initiation and management of the registration process for new product submissions.Ensure approval of registration applications of all medicines with the relevant authorities.Ensure...

  • Regulatory Affairs Pharmacist

    1 week 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

    1 week 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

    2 weeks 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

    2 weeks 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 Pharmacist

    2 weeks ago

    Johannesburg South, South Africa Emporium Human Capital Full time

    Regulatory Affairs Pharmacist (POS24192)Area; AerotonSalary R750 800kPurpose of the role:Support the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners and Principals, and to control and manage portfolio outputs. To ensure legal compliance with the relevant medicine Regulatory...

  • Regulatory Affairs Pharmacist

    4 weeks ago

    Johannesburg South, South Africa Emporium Human Capital Full time

    Regulatory Affairs Pharmacist (POS24192)Area; AerotonSalary R750 800kPurpose of the role:Support the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners and Principals, and to control and manage portfolio outputs. To ensure legal compliance with the relevant medicine Regulatory...

  • Snr Regulatory Affairs Pharmacist

    11 hours ago

    Johannesburg, Gauteng, 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.ResponsibilitiesPrepare and submit regulatory applications for the registration of...

  • Regulatory Pharmacist

    2 weeks ago

    Johannesburg, South Africa PSM Personnel Full time

    Regulatory Pharmacist Regulatory Johannesburg North-Gauteng Our client, one of the leaders in the pharmaceutical industry is looking to hire a Regulatory Affairs Pharmacist to support the Regulatory Affairs function with both pre and post registration and dossier submission activities by assisting in data gathering, screening, collating, and compiling of...

  • Regulatory Affairs Specialist

    2 days ago

    Johannesburg, Gauteng, South Africa Emporium Full time

    Emporium is seeking a highly skilled Senior Regulatory Affairs Pharmacist Complimentary to join our team. As a key member of the regulatory affairs department, you will play a critical role in ensuring compliance with relevant legislation and regulations.The ideal candidate will have a Bachelor's Degree in Pharmacy, registration with the South African...

  • Regulatory Affairs Pharmacist Lead

    6 hours ago

    Johannesburg, Gauteng, South Africa Hire Resolve Full time

    We are looking for a highly experienced Regulatory Affairs Pharmacist Lead to join our client's team. In this role, you will play a critical part in ensuring compliance with regulatory requirements and overseeing the registration of pharmaceutical products.Job Description:Oversee the preparation and submission of regulatory applications for product...

  • Regulatory Affairs Pharmacist

    6 days ago

    Johannesburg, Gauteng, South Africa Emporium Full time

    Regulatory Affairs Pharmacist (OTC) – POS24326Area: MidrandSalary: R900 – R1mQualificationsBachelor's 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

    2 days ago

    Johannesburg, Gauteng, South Africa Emporium Full time

    Regulatory Affairs Pharmacist (OTC) – POS24326Area: MidrandSalary: R900 – R1mQualificationsBachelor's 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 and Deputy

    1 week 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...

  • Regulatory Affairs Pharmacist

    2 weeks ago

    Johannesburg South, South Africa Emporium Human Capital Full time

    Regulatory Affairs Pharmacist (CC) POS24329Area: AerotonSalary 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 Specialist

    6 days ago

    Johannesburg, Gauteng, South Africa Emporium Full time

    **Job Summary:**We are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Emporium.The successful candidate will be responsible for managing work streams and reporting on assigned portfolios of products, including internal and external product queries.Key Responsibilities:Establish regulatory priorities and allocate resources and...

  • Senior Regulatory Affairs Pharmacists

    1 week 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...

  • Regulatory Affairs Specialist

    2 days ago

    Johannesburg, Gauteng, South Africa Emporium Full time

    Job OverviewEmporium is seeking a highly skilled Regulatory Affairs Pharmacist to join our team. The successful candidate will be responsible for managing work streams and reporting on assigned portfolios of products.Key Responsibilities:Manage work streams for- and report on the assigned portfolio of productsInternal product queries from relevant...