Head of Regulatory Affairs, Responsible Pharmacist

2 weeks ago

Johannesburg, South Africa Takeda Pharmaceutical 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 Regulation 28:

- Continuous supervision of the business;
- Registration with the Pharmacy Council of relevant persons;
- Corrective measures taken in terms of audits performed by the Pharmacy Council and Regulatory Authority;
- Ensure that only a

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