Job at Pfizer for a Regulatory Affairs Manager

Pfizer – Good health is vital to all of us, and finding sustainable
solutions to the most pressing health care challenges of our world
cannot wait. That’s why we at Pfizer are committed to applying science
and our global resources to improve health and well-being at every stage
of life. We strive to provide
access to safe, effective and affordable
medicines and related health care services to the people who need them.

Pfizer is recruiting to fill the position below:


Job Title:
Regulatory Affairs Manager
Job ID: 1035293
Location: Lagos, Nigeria
Department/Group: GEP RA International, Africa Middle East
Position Purpose

  • The PCO based Regulatory Manager for a country will lead, manage
    and provide strategic direction to develop and execute regulatory
    strategies and plans for the country and/or products under his/her
    responsibility, where applicable. 
  • The PCO Regulatory Manager would represent Regulatory on the
    Country Manager Forum (CMF) and local Country Medical Council (or
    equivalent) to ensure collaborative connectivity with these key
    stakeholders (e.g. Commercial, Medical, etc), and a more focused
    regulatory approach to supporting country business objectives.

Primary Responsibilities

  • Lead and manage the development of regulatory strategies to
    support the registration of clinical trial applications, new products,
    line extensions, major variations and lifecycle management.  Ensure to
    provide strategic regulatory input into global regulatory strategies,
    thus providing optimal support for meeting local business objectives.
  • Develop strong partnerships with in-country teams (e.g. Country
    Managers, Medical, Marketing, Supply Chain), Regulatory Clusters,
    Regulatory Regional Teams to facilitate the development and
    implementation of registration strategies to expedite the registration
    of new products, line extensions and lifecycle optimization.
  • Active participation in trade organization of country and
    effective communication to key stakeholders of key issues that could
    impact regulatory strategies or the business.  Understand local
    regulations and developing trends in the local regulatory environment of
    the countries that support and provide assessment of the impact to key
    stakeholders.
  • Leverage regulatory intelligence / landscape knowledge to
    support the development and implementation of regulatory and business
    strategies, and decision making. Influence on new sanitary legislation
    initiatives that could impact the business.
  • Provide strategic contribution to the country (PCO) leadership
    team – anticipate what Regulatory needs to contribute to achieve
    business objectives.
  • Responsible for developing and enhancing relationships with key
    external agencies (HA’s/BoH, RKOL’s, etc.).  Manage the HA/BoH interface
    throughout the development and lifecycle of a product, developing a
    long-term and positive relationship characterized by Integrity, Quality,
    Compliance and Leadership. Face before the MOH authorities
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Technical Skill Requirements

  • Knowledge of the Local regulatory environment and how this impacts regulatory strategy and implementation.
  • Influencing
  • Team working
  • Interpersonal acumen
  • Organizational agility
  • Perspective
  • Strong quality and compliance orientation
  • Analytical Thinking
  • Adaptability
  • Knowledge of drug development practice, rules, regulations and guidelines.
  • Communication skills
  • Negotiation skills
  • Problem Solving
  • Understands Pharmaceutical Industry
  • Understanding stakeholder needs
  • Network and alliance building/ peer relationships

Qualifications

  • Pharmacist Degree or A higher degree (MS or PhD) may be an advantage but is not essential.
  • Appropriate Regulatory Experience – minimum 5 years’ experience
  • Proven ability to consistently deliver to time, cost and quality standards.
  • Local regulatory experience including knowledge of CTA’s and NDA
    submission processes and product life cycle management activities.
  • Demonstrable experience of effective delivery in a complex matrix environment.
  • Demonstrable experience across the Drug, Discovery, Development
    and commercialization lifecycle, with proven examples of contribution.
  • Proven ability to manage complex regulatory issues.

Organizational Relationship(s) including to whom the position reports (JD Job Title):

  • Direct Report to Head Regulatory Affairs East and West Africa Cluster
  • Member and strategic contributor to the Country Medical Council and other PCO based teams (new product planning teams, etc.)
  • Member and strategic contributor to the Country Manager Forum (CMF)

How to Apply
Interested and qualified candidate should:
Click here to apply

Note: When the page opens, enter the Job Opening ID (1035293) in the Job ID Box, and click “Search”

Application Deadline  21st September, 2016.

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