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  • Posted: Jun 14, 2022
    Deadline: Not specified
  • Pfizer South Africa’s vision of "living our full potential in striving for a healthier Southern Africa" forms part of Pfizer’s ethos whereby every Southern African should have access to quality healthcare. At Pfizer South Africa we are dedicated to the improvement of human life and the battle against disease & disability. We have...
    Read more about this company


    Regional Regulatory Hub Strategy Senior Associate (AfME)

    Job Summary
    Summarize the primary purpose & key accountabilities of the job.

    • Handle related regulatory strategies for allocated Products, and ensure communication/clarity of regulatory timelines and strategy.
    • Single point of contact for global/product strategists, and In-Country Regulatory Team on regional issues to facilitate the best in class support for product registration and product life cycle management activities.
    • Responsible for ensuring that regulatory documentation meets relevant regulatory requirements.
    • To apply knowledge and best interpretation of regulatory requirements in the assigned countries to the drug development process, including promulgation of health authority marketing authorization dossiers to enable efficient and effective registration of medicinal products consistent with the supported regions commercial objectives.
    • To ensure business continuity between global/product Strategists and In-Country Regulatory Team.

    Job Responsibilities
    Indicate the primary responsibilities critical to the job.

    • Maintain effective regional relationship with stakeholders to ensure communication /clarity of regulatory strategy and timelines.
    • Apply regulatory expertise for assigned Products/countries to enable preparation of high quality documentation and assure compliance with departmental procedures.
    • Assist and liaise with GCMC, global/product strategists, PGS, Submissions Management, In-Country Regulatory , ILG, ALIM, Cluster/Market, and any other key stakeholders to ensure the filing strategies are defined and executed and BoH requirements are met, ensuring a submission ready dossier. Ensure that the appropriate regulatory requirements systems and database are updated in a timely manner when changes occur in market regulations. Ensure a submission planning and forecasting tool is utilized to update timelines.
    • Assist and support all product lifecycle regulatory work, and liaise with GCMC, Submissions Management, Cluster/Market, and any other key stakeholders.
    • dispatch dossiers to In-Country Regulatory .
    • Regularly follow up with In-Country Regulatory Team on progress of registration submission and approval activities, and ensure line management are advised of progress in regulatory filings.
    • Maintain Pfizer systems and databases, and applicable Pfizer policies and procedures.
    • Responsible for ensuring product strategies, submission and approval time lines, and country registration requirements/guidelines are accurately captured and current in applicable systems/regulatory databases.
    • Responsible for ensuring notifications of proposed regulatory changes are communicated to relevant stakeholders in a timely manner.
    • Responsible for ensuring that comprehensive records of country requirements (communication of requirements for RRM updates) and regulatory status, are maintained.
    • To regularly follow up progress on regulatory submissions with In-Country Regulatory.
    • Contributes to the development of filing and approval goals for the region.
    • Ensure systems are in place and adhered to, to optimize process efficiency with out-sourced and in-house contractors, where applicable.

    Qualifications / Skills
    Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.

    • Scientific Degree. A higher degree (Pharmacy, BSc) may be an advantage but is not essential.
    • Appropriate Regulatory Experience : 1-3 years’ experience
    • Proven ability to manage complex regulatory or drug development issues.
    • Proven ability to consistently deliver to time, cost and quality standards.
    • Attitude: Right mindset, Outward looking, Strategically minded, Project management skills preferred
    • Country/regional knowledge (For AfME only - specifically, MER, NEAR, South Africa, Maghreb)
    • Knowledge of drug development practice, rules, regulations and guidelines.
    • Technical skills with respect to understanding of CMC submissions, BoH Requirements to identify potential risks
    • good communication, negotiation and interpersonal skills
    • Strategic thinking
    • Change agile
    • Analytical thinking
    • Detail- and compliance orientation
    • Big picture thinking

    go to method of application »

    Senior Medical Manager Oncology

    The Oncology Senior Medical Manager is responsible for developing and executing the medical plan that supports the strategic operating goals for the oncology business, supports cross-functional projects, and is accountable for his/her medical and scientific initiatives related to oncology products. To develop strategic partnerships with key external stakeholders during the entire life cycle of Pfizer products, providing focused relevant information in response to customer-stated needs in order to maintain a therapeutic leadership position and drive business needs at the national, regional & corporate levels.

    Position Responsibilities

    • Develop and execute a medical strategy that supports the country operating plans with a specific focus on driving business growth through medical insights
    • Provide country perspective for the oncology assets at Oncology reviews and planning (together with country Commercial/marketing, Regulatory Affairs, and Legal functions)
    • Medical input into assigned brand cross functional team and where necessary into local Customer based marketing initiatives
    • To interact with and develop enduring relationships with national opinion leaders, national advisors on clinical practice, contributors to national guidelines and management protocols
    • To communicate customer feedback on product development and life-cycle strategies
    • Dissemination of recent scientific knowledge/data on Oncology portfolio in approved indications
    • Communication of recent scientific knowledge/data on Oncology portfolio in off-label indications and on Oncology products in development upon request
    • To provide quality scientific presentations at internal and external meetings
    • Soliciting feedback on clinical trial programs and protocols (feasibility) from potential investigators for Oncology portfolio
    • Management of IIRs-presentation of proposal, internal scientific review, & conduct follow up
    • Conception, management and implementation of observational (Non Interventional) studies
    • Collaborate with oncology medical teams to support development of a strategic regional/country publication plans.
    • Medical lead for local/national advisory boards: - Advisory Boards conduct to gather expert guidance to advise medical planning. - Provide input into regional Advisory Board planning, support implementation and presentations (as needed).
    • Conduct of medical to Medical Local medical education activities
    • Medical support for formulary applications when needed
    • Provide country oncology medical leadership, support and guidance for label updates and responses to regulatory requests when needed.
    • Provide country medical support, analysis, and guidance for drug safety updates or issues pertaining to oncology portfolio.
    • Deal with customer enquiries on drug safety issues for Oncology portfolio
    • Medical societies identification and collaboration relevant to Oncology BU
    • Medical support for other customer facing teams, including medical training
    • Provides a critical review and medical input into promotional materials and marketing strategy.
    • Partner with legal, regulatory and marketing colleagues to ensure compliant, accurate and high quality content of all promotional and training materials

    Education And Experience

    • Medical doctor (MBChB or MD) is a minimum requirement.
    • At least 3 years Pharmaceutical Medical Affairs experience (Oncology Background Preferred).

    Technical Skills Requirements
    Technical skills required and/or preferred, as applicable.

    • An appropriate Oncology therapeutic knowledge is preferred as well as an understanding of the therapeutic context and of the products in the portfolio
    • A good understanding of clinical research as well as the ability to critically evaluate clinical studies whether a protocol or a publication
    • An understanding of the national and regional health environment including its structure, policy, key members and scientific societies
    • An understanding of the process of drug development
    • Knowledge of the relevant and applicable Codes of Practice, SOPs, regulations and guidelines as they apply to the function.
    • Knowledge of pharmacovigilance and regulatory legislation and how it impacts the product portfolio
    • Strong business acumen- Knows the industry; knowledgeable in current and possible future trends, technology, and information affecting his/her business and organization; knows the competition; is aware of how strategies and tactics work in the marketplace.
    • HCP focus- Is dedicated to meeting the expectations and requirements of internal and external customer’s products and services; always focused on patient safety first, establishes and maintains effective relationships with customers
    • Organization alignment- Is aligned with the culture, values and mission; operates with the mission and values in mind; encourages others to act in a manner aligned with organizational culture, values and mission.
    • Results driven- Can be counted on to exceed goals successfully; steadfastly pushes self and others for results.

    go to method of application »

    CBL, Antifungals (AF)


    • Own & develop brand strategy for market. Define and drive country specific therapeutic area plans, drive product growth and lifecycle management, forecast revenue and opex of  assigned brands, ensuring the realization of revenue and profitability targets in country


    • Provide local insights and brand feedback to Category Lead & Regional Therapeutic Area Lead (RTAL)
    • Tailor brand and execute brand strategies to local market needs, and define local priorities for a brand
    • Manage brand & portfolio P&L Select best-fitting modules from cross-EM content; translate and localize material as needed
    • Manage local agencies for localization (budget, scope, timing, and quality of project)
    • Forecast brand performance and track progress towards targets
    • Allocate and execute in country brand budget Cross-functional brand leadership – across Field Force, Key Account Management, Medical, Regulatory etc. Train Field Force on product positioning and prioritization
    • Partner with Medical to educate KOLs on emergent medical research and differentiated product attributes



    • Brand Plan: review of brand strategies Brand P&L Campaign Development:  Select best fitting modules for country, including Omnichannel strategies Promo Meetings:  Manage compliance review of materials

    Shared Accountability

    • Develop country Op Plan and influence sales targets and brand A&P allocations Long-range forecasting Revenue adjustments, as needed Develop promotional meetings strategy with Regional Therapeutic Area Lead (RTAL) and Portfolio Marketing Lead Validate brand-specific messages, design training in collaboration with Medical Develop awareness campaigns, congress content in partnership with Medical



    • 5 – 8 years of marketing experience Therapeutic area related experience will be an advantage Bachelor’s Degree Masters degree or MBA desired


    • Technical skills required and/or preferred, as applicable.

    Candidates to demonstrate these commercial /management competencies

    • Marketing, Customer and Competitor Insight
    • Marketing Execution
    • Strategic and Operational Business/Marketing Planning
    • Data analysis, interpretation and communications
    • Performance and Program Metrics
    • Exceptional interpersonal skills
    • Exceptional collaboration/negotiation  skills  (With Customer Facing roles, RTAL, Category Lead and Country Manager)
    • Exceptional prioritization, resource allocation & management
    • Vendor management

    Method of Application

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