Head of Regulatory Operations, Scientific Affairs

2 weeks ago

Cape Town, South Africa Johnson & Johnson Full time

**Johnson & Johnson Consumer **business is recruiting for a **Head of Regulatory Operations, Scientific Affairs and External Engagement, SSA **Cluster **, located in **Cape Town, South Africa.**

**Broad Purpose / Function**:
Lead all Scientific Affairs (including but not limited to Regulatory & Medical Affairs, External Engagement, Government Affairs, Policy & Advocacy for the South Africa, Sub-Saharan Africa sub-cluster in addition to Nigeria operations, Ghana & other East Africa Distributor markets in line with the strategic objectives of the Johnson & Johnson Consumer business under the umbrella of the EMEA R&D organization.

Responsible for developing and coordinating the execution of all regulatory strategy and operational activities to support new product innovation and product lifecycle management in the South Africa Sub-Saharan Africa sub-cluster.

Acting as Responsible Pharmacist (RP) for the Johnson & Johnson manufacturing facility in line with the requirements of the Pharmacy Act, 1974 (Act 53 of 1974) and the Medicines and Related Substances Act, 1965 (Act 101 of 1965, as amended.

Overlook the New Co.’s Pharmacovigilance-PV role and responsibility (locally) and act as the ‘Focal-point-of-contact’ for New Co.’s Global and/or EMEA Safety organization in terms of embedding local safety reporting systems and procedures, in addition to building collaborative networks (locally) towards fulfilling our commitments in-line with PV legislations set in-place by all local Health authorities across the sub-cluster.

**Key Responsibilities**:

- Regulatory Strategy and business orientation - Provide leadership and direction in settling appropriate tactics and strategies for the Regulatory Affairs components of the J&J product portfolio in support of the local and regional business goals
- Participate as a member of the Local Operating Company Board and other local business Leadership teams to represent the interest of Scientific Affairs which includes but is not limited to Regulatory, Medical, External Affairs, Policy/Government Affairs, Quality, Pharmacovigilance, Compliance, and Pharmaceutical Manufacturing. Provide strategic direction and advice to local business initiatives
- Provide direction and consultative support to marketing teams on business decisions with regulatory implications by supplying an understanding of the potential risk and benefit and advising alternate plans based on benefit /risk analysis
- Participate in local and regional project and business teams as appropriate to achieve organizational goals
- Proactively follow/anticipate global regulatory trends and translate impact on local regulatory environment for potential impact on business
- Actively Engage externally with Key Policy makers and influential KOLs to shape the Government Policies towards building our New Cooperation fronts needed to advance our New Co.’s establishment & increase its competitiveness within relevant industry
- Influence and craft the external environment through representing the company to individuals and bodies outside the company and playing a key role in establishing and building relationships in industry associations and regulatory agencies
- Optimally develop the local team(s) and networks to deliver best-in-class business partnerships by providing leadership, coaching, building capabilities and identifying development opportunities for key talents
- Ensure Compliance with Corporate Quality, Safety/Pharmacovigilance and Regulatory Policies and Procedures, as well as various laws and regulations pertaining to registration, marketing, and product safety reporting.
- Responsible Pharmacist
- Act as Responsible Pharmacist (RP) for the Local Operating Company and provide the required supervision over responsible team and activities through appropriate delegation, in line with requirements set out in regulation 25 (3) of the Pharmacy Act and the relevant sections of the Medicines Act, as detailed in the SA Guide to GMP
- Delegate the relevant duties of RP responsibilities as required, to the functional leads of the quality and manufacturing divisions of the company, with acceptance acknowledged in writing
- Responsibility for Quality Assurance to the QA Manager and QA Pharmacists concerned with Product release.
- Responsibility for Production to the Production Leader
- In case of absence, delegate responsibility for RP duties to relevant functions align with the PW510018 SOP-013858 - QO Authorised Signatories and Delegation of Authority and PP2100016 SOP-016706 - QO Site Master File.
- Participate on the Management Quality Review Board in capacity of both RP and Regulatory & Medical Affairs lead for the periodic review of activities and events impacting the Overall Quality Management System. Review includes; Action items from previous meeting; advanced events; results of internal / external and HA/regulatory inspections; non-conformances; change controls, GMP training, annual product review; suppli

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