Regulatory Affairs Manager- West Africa

Job Summary

Manages and provides regulatory support of JnJ Consumer product portfolios for the West-African region of the SSA cluster, including registration, pre-approval and post-approval activities for medicinal products, medical devices, complementary medicines and cosmetics. Manages in-country 3rd party Local Technical Representatives (LTRs) in Nigeria and Ghana. Provides distributor oversight for the East African region (Kenya, Tanzania, Uganda and Rwanda), in line with the strategic objectives of the Johnson & Johnson (JnJ) Consumer Sub-Sahara Africa business. Ensures compliance with J&J guidelines and the local laws and regulations within scope for the markets of the East and West-Africa region of the Sub-Sahara Africa cluster.

  • Minimum Qualification: Degree
  • Experience Level: Senior level
  • Experience Length: 5 years

Job Description/Requirements

Regulatory Strategy and business orientation:

  • Participates as a member of the Nigeria local operating company leadership team to represent Consumer Regulatory Affairs, providing strategic direction and advice on local business strategy and initiatives as required
  • Provides distributor / LTR oversight for the East African region
  • Understands and interprets the regulatory environment for East and West Africa in terms of applicability to the JnJ business
  • Anticipates barriers and develops alternative plans of action
  • Develops regulatory strategy for the development of products (eg. New applications, line extensions, reformulations, etc.) for product portfolio in line with business objectives
  • Provide regulatory strategy and advice and ensure that appropriate due diligence is carried out for product acquisitions and distributor agreements with third parties
  • Provides consultative support to product marketing teams on business decisions with regulatory implications
  • Executes regulatory plans and manages timelines to achieve the stated goals.

Manages Product Portfolio:

  • Effectively manages the portfolio of products in the West-Africa region in all aspects of Regulatory Affairs, together with the regulatory brand portfolio owners, and ensures timely completion of activities in line with departmental, regional, and business goals.

Registration of New Products/Claims and Product Lifecycle management:

  • Assumes responsibility for the preparation, review, submission, follow-up, and registration of regulatory submissions (including but not limited to: New MA dossiers, new claims, renewals, variations, response to questions) that are properly formatted and in compliance with local regulations and business goals. Prepare local/administrative sections where no local regulatory responsible is designated according to country-specific requirements.
  • Conducts document review and gap analysis to ensure regulatory quality and scientific integrity of documents submitted to regulatory authorities for West Africa
  • Monitors, follows up and reports on the progress of regulatory submissions for East and West Africa
  • Provides expert input into product labeling development and updates in line with corporate and country regulatory requirements
  • Updates and maintain supportive databases with product license status changes 

Advertising and Promotional Material Approval:

  • Reviews and approves advertising and promotional material ensuring compliance with country regulatory requirements, marketing guidelines and corporate standards
  • Ensures that agency approval is obtained for advertising material prior to commencement of advertising campaigns in the appropriate countries

Communication and Influencing:

  • Interacts and participates in negotiation discussions on regulatory matters with Regulatory Authorities, as appropriate
  • Develops and maintains relationships and contacts with key personnel at the Regulatory agencies, key opinion leaders, academics and peers within the industry
  • Actively participates in trade associations to positively shape the external regulatory environment
  • Represents the company/department to internal and external clients
  • Ensures that business is conducted tactfully and professionally and that a favorable company image is created and maintained
  • Develops a network within the JnJ organization, and effectively interacts at multiple organization levels and with diverse, multi-disciplinary individuals to encourage information flow and dissemination
  • Maintains contact and builds relationships with company subsidiaries and third-party agents as relevant.
  • Develops, maintains and demonstrates in-depth knowledge of local and major international laws and regulations pertaining to regulatory affairs, and their implications to JnJ.
  • Bring to management attention in a timely manner, any proposed changes in national regulatory laws and procedures where the company has an interest.
  • Provides legal, technical and relevant medical information and guidance, plus necessary recommendations to the relevant internal and external clients
  • Provides regulatory input and guidance to project teams and departments as required e.g. NPD project teams, Supply Chain, Marketing

Compliance with Corporate Quality and Regulatory Policies and Procedures:

  • Understands and implements relevant JnJ Corporate Policies and procedures and ensures compliance. Ie. Ensures HCC and legal requirements (Fair Market Value, Transfer of Value rules, Promotional Materials rules) are fully understood, appropriately managed and, where applicable, complied with when planning projects, developing materials, executing projects and contracting vendors
  • Works in close collaboration with regulatory and manufacturing counterparts within the company to ensure the efficient and consistent execution of strategic regulatory plans across JnJ's portfolio and be accountable for regulatory compliance within the area of responsibilities.
  • Participates in regulatory inspections and corporate audits as required
  • Ensures audit readiness and be the key contact point for requests for information (RFI) in East and West Africa.
  • Ensures systems, procedures and practices are in place to maintain compliance and adherence to regulatory agency and corporate requirements
  • Ensures company and professional licenses regarding pharmacy and manufacturing activities are renewed and maintained in line with local country regulations
  • Conducts periodic internal audits of regulatory documentation to assess compliance risk and ensure compliance with local, corporate and regulatory agency requirements

Qualifications:

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

  • Bachelor's Degree in Pharmacy is required.
  • Pharmaceutical industry experience with at least 5 years in the Regulatory field is required.
  • In-depth regulatory knowledge pertaining to the areas of responsibilities and their implications to Johnson & Johnson, good business acumen, knowledge in Quality, proficiency in basic project management, and use of business tools.
  • Proficient in English.
  • Applied technical knowledge.
  • Regulatory Strategy and business orientation.
  • Sound decision making and prioritisation in a complex environment.
  • Strong communication skills, both verbal and written.
  • Strong influencing and interpersonal skills with multiple levels of the organization within a matrix environment.
  • High energy leveled individual.
  • Strong leadership skills through an open and inclusive environment.
  • Demonstrated ability to manage multiple priorities and deliver excellent results.
  • Big picture orientation with attention to detail.
  • Ability to multi-task, work under pressure, and meet deadlines.
  • Strong self-management and organizational skills.
  • Integrity & Credo-based Actions.

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