Head of Regulatory Affairs at Johnson & Johnson

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 monitor individual objectives and the means of implementation
• Implement necessary actions to ensure positive environment and business continuity
• Organize and facilitate team meetings and collaboration
• Conduct evaluation of reports in regular basis and establish salary recommendations

QUALIFICATIONS

We’d love to hear from YOU if you have:

• A minimum of a University degree - medical or paramedical (pharmacy, biology, veterinary, etc.)
• Breadth of regulatory experience in drug development and market access (e.g. experience in multiple products, multiple phases of development, multiple therapeutic areas) - 10+ years of relevant industry experience.
• In-depth knowledge of the regulatory environment, guidelines, and practice of the ZA region is required
• People management skills, complex project management skills, and excellent oral & written communication skills, as well as experience working in a matrix organization will be needed
• Excellent English verbal and written communication skills are required. Portuguese would be an advantage