Snr Regulatory Affairs Portfolio Manager

JOB DESCRIPTION

Job Title

Senior Regulatory Affairs Portfolio Manager

Job Purpose and Scope

Ethical & legal responsibilities:

• Build relationships with key stakeholders and represent Abbott in an appropriate manner according to company values, in order to present Abbott policies and strategies.

• Keep abreast with new developments in legislation, guidelines and regulations of the NMRAs in the countries within scope of responsibility, and cascade these locally and globally within the organization.

• Ensure compliance to Abbott Global and Regional Regulatory Affairs Quality Systems, policies and procedures.

• Manage regulatory associates, regulatory consultants and regulatory team members for regulatory projects and activities as required,

• Liaises with external stakeholders on regulatory matters as required.

• Responsible for ensuring that new products are registered and existing registrations are maintained in accordance with the current requirements of the National Medicine Regulatory Authorities (NMRA) of each country within the English Africa Cluster (EAC).

• Ensure that promotional material for marketed products comply with the relevant product registration and any country-specific Codes of Marketing Compliance.

Core Job Responsibilities Core Responsibilities:

1. Registration of new products:

• Provides guidance on regulatory strategies and requirements for new NPI opportunities / projects.

• Works in collaboration with the Regional Product Lead (RPL) to proactively assess local submissions requirements, review & sign-off content for registration packages accordingly.

• Conducts dossier due diligence to ensure all data gaps are addressed in preparation for new registration applications. Abbott Laboratories S.A. (Pty) Ltd JOB DESCRIPTION

• Prepares the registration applications for submission to the NMRA in conjunction with the relevant RPL's.

• Orders samples and other relevant data as per local requirements and internal processes.

• Prepares the submission of appeals to negative responses and responses to deficiency letters received from the NMRA, in a timeous manner.

2. Maintaining existing registrations:

• Maintains existing product registrations in line with current legal and internal requirements for allocated portfolio of products

• Prepares and submits technical updates based on the review of current data versus data contained in the registration application.

• Compiles and submits technical amendments based on requests and data received from the registered manufacturing site and I or the RPL. Requests data required to do the technical updates from the RPL.

• Compiles and submits package insert amendments based on revised reference labels received by Area Labelling Coordinator.

• Follows up with the local distributor or Health Authority for submissions pending approval.

• Reviews and approves new artwork and updates to artwork in line with regulatory requirements to be uploaded to artwork system by RA associate.

• Ensures compliance of printed packaging components with updated regulations and corporate branding requirements.

• Compiles and submits renewal packages for countries where this is required within agreed timelines to ensure no loss of registration license.

• Reviews and approves promotional material for marketed products to ensure compliance with the relevant product registration and any country-specific Code of Marketing Compliance.

3. Legislation, Regulatory Authorities & Process Improvement:

• Keeps abreast of new developments in legislation, guidelines and regulations of the NMRAs, interprets and cascades these locally and globally within the organization.

• Manages and monitors changes in the regulatory landscape in line with the Regulatory Intelligence process and ensures stakeholders are updated on new requirements.

• Attends meetings with respect to new developments in the Regulatory Affairs arena. Liaises with the NMRAs and appointed Agencies on new developments in the registration process, and ongoing activities for registered products.

• Ensures that all communication with health authorities and agencies are copied to regulatory mailbox, and that all correspondence with health authorities are completed on the relevant trackers and databases.

• Communicates approvals from health authorities to relevant stakeholders.

• Identifies and recommends opportunities for improvement to the existing processes, quality systems, regulatory systems and tools and policies.

4. Liaising internally and with other departments:

• Liaises with Business Development to advise on regulatory requirements for new product registrations.

• Liaises with QA colleagues regarding changes impacting on product quality. • Liaises with Medical I PV colleagues regarding new registrations, changes to registered package inserts & safety notifications, and provides regulatory support as required. Liaises with the Sales & Marketing department to advise them of the registration status of products, approval status of amendments, and provides regulatory support for product launches and other commercial activities as required

• Liaises with Operations to keep them abreast of current local regulatory and legal requirements and provides updates on any regulatory activities which may have an impact on supply.

• Assists Operations when requested to do so, on projects that affect or could affect the registration of products.

• Manages regulatory risks with regulatory team and leads cross-functional meetings to communicate risks and ensure mitigation ahead of time.

• Meets with relevant stakeholders to provide updates on projects and key activities led by regulatory.

5. Management of quality documents relating to Regulatory Affairs processes:

• Ensures compliance to EPD Global & Regional RA Quality Systems, policies and procedures.

• Initiates, reviews and updates affiliate RA quality documents as required.

• Ensures training is carried out with the relevant employees and documented.

• Oversees and maintains regulatory SOP's up-to-date, and leads the team on all SOP related activities.

6. Leadership Responsibilities

• to Continually assess and build on leadership capabilities to effectively lead regulatory associates, regulatory consultants and regulatory team members in regulatory projects and activities as allocated.

• Deputises as head of department in local, regional or global meetings when required to.

• Manages and tracks action logs for team to ensure timely completion of agreed actions.

• Leads team in regulatory activities when directed to do so by head of department.

• Supervises RA Associates & RA interns in line with their job descriptions and portfolio allocations and annual objectives.

7. Liaising with External Stakeholders

• Communicates with legal technical representatives during regulatory landscape meetings to track submissions and regulatory updates from NMRA's, and for ad hoc queries Communicates with health authorities, third party suppliers / service providers and trade associations as required.

Quality Responsibilities:

• Establish and maintain quality management Process by maintaining department procedures in updated status.

• Maintaining Data Integrity principle and Good Documentation Practice within area of responsibility.

• Ensure training is completed as planned.

• Attend any quality related training.

• Report any customer complaint to quality within 24 hours of awareness.

• Identify any quality related risk in area of responsibility, report to quality, support in risk creation, mitigation.

• Identify any quality related incidents in area of responsibility (Planned deviation, Exception, non conformity, Significant Event) report to quality for assessment and proper documentation.

• Support and participate in any Investigation process with regards to ER, Deviation, Complaints, others.

• Complete assigned CAPA actions according to due dates and prevent any overdue escalation in regional management review.

• Support as required in executing Product Actions / recalls. (Applicable only for Quality, regulatory & Supply chain departments).

• Attend Quality Management Review quarterly meetings.

• Initiate any change controls relevant to job responsibility, support in change control forum & complete related actions as per timeline.

• Support in audit readiness activities, participate in audits as required. Adhoc Duties:

Minimum Skills Required;

• Attention to detail.

• Team player.

• Understanding local Guidelines.

Experience Required:

• 2 - 3 years RA experience.

• Bachelor of Pharmacy, Pharmaceutical science.