Head of Regulatory Affairs

**The Head of Regulatory Affairs ZA **will be responsible for leading regulatory affairs activities in the cluster for the Janssen portfolio and support local GPH regulatory team as required striving for convergence in ways of working.

The position may also have Local QP responsibility.

**Reports to**:

- Direct line to Managing Director ZA
- Dotted to Snr Director Regulatory Affairs EMEA Emerging Markets and EMEA GPH

**The main duties and responsibilities of the position are**:
**Strategic and tactical input in development, post-approval and Life cycle management**
- Develop and ensure effective implementation of regional (central and national) regulatory strategy and tactics in support of the global development and life-cycle management plan
- Develop and implement country objectives based on Janssen business priorities, and global regulatory strategies and plans
- Align with Regional organization on accountabilities and interfaces to create the country-specific regulatory strategy for registering new products and existing products
- Provide leadership and manage relationships through extensive interdependent partnering, benchmarking, leveraging of best practices, and forming strategic alliances with cross functional partners to drive key business goals and objectives
- Coordinate with other Regional RA leaders as appropriate to develop and harmonize efficient processes and ways
- Accountable and responsible to plan and direct resources and activities of the ZA regulatory group to deliver business imperatives; maintain product regulatory compliance and sustain market access
- Overview of OpCo/ Cluster team activities to ensure:

- efficient workflow and transparency
- creation of technical documentation required to register new products in markets
- project prioritisation across multiple business units through collaboration with internal RA partners and other functional business partners
- regulatory submission planning to support product registrations and maintenance in line with internal processes
- Provides support for Supply Chain and Compliance initiatives that impact the portfolio of marketed products (e.g. cost improvement and network optimization projects, newly regulated markets, changes in post-market registration requirements)
- Accountable for Regulatory Compliance in the cluster / instils a mindset of Regulatory compliance within the team
- Drives effective business strategies to ensure regulatory programs and projects within ZA are standardized to obtain earliest possible approvals.
- Provides measurable input into the development and implementation of Regulatory Affairs processes, standards, or plans in support of the organisation’s strategies.
- Provides overall management of the Regulatory staff development and budget to support business objectives.
- Accountable for Local SOPs/ LIDs in accordance with the applicable responsibilities scope.
- Serve as primary Regulatory liaison for the cluster and be an active participant on the Cluster leadership team (ZA LT)
- Accountable for ensuring timely provision of regulatory input for and appropriate follow-up to inspections, audits, litigation support and product complaints
- Plans and oversees team membership in different RA network for different countries for challenging and getting into one industry regulatory voice of customer

**Liaison with Regulatory Agencies**
- Establish and maintain strong relationships with Regulatory Agencies and effectively negotiate with Regulatory Agencies on product-specific labelling, study design, submissions content, and post-approval commitments.
- Drives understanding of central and national regulatory requirements
- Develop a deep understanding of the regional regulatory environment, competitor intelligence across therapeutic areas in the market scope.
- Ensure appropriate implementation of scientific advice/Regulatory Agency comments into development and life-cycle management plan of portfolio in scope.
- Ensure appropriate involvement and liaise with LOC regulatory affairs personnel to facilitate local Regulatory Agency meetings, mentor, coach and supervise
- Prepare team, manage, conduct and facilitate contacts/meetings with Regulatory Agencies and scientific advices.
- Ensure issues raised by Regulatory Agencies are promptly and adequately addressed
- Negotiate labelling with Regulatory Agencies, going through each of the back-up strategies

**Clinical Trial Applications (CTA)**
- As applicable, ensure protocols are developed in alignment with regional registration strategies to support registration, reimbursement, and competitive labelling

**Talent and Development**
- Ensure training and provide leadership to the team to ensure talent development and experience sharing within the cluster and wider region
- Ensure a pipeline of succession planning within the ZA cluster
- Ensures team diversity and creates a culture of innovation in line with Johnson and Johnson Credo values
- Identify, set and mon