Regulatory Affairs Manager, WSR-I Asia (Pakistan/Afghanistan)
Pfizer
Karachi, ,Pakistan
20d ago
  • To oversee, provide leadership and strategic direction of specific BU portfolio (PIH) in country
  • Management of Regulatory Affairs team in country
  • To interface with other function leads (e.g. GCMC, Reg Ops, PGS, Commercial, Medical) to ensure collaborative connectivity with these key stakeholders, and a more focused regional RA approach to supporting country and regional business objectives and ensure product access.
  • Delivery of innovative pharmaceutical products with competitive labelling to the region in timely manner.
  • Be a recognized partner for internal in-country stakeholders (PGS, Medical, Commercial etc.)
  • Establish, and maintain, strong relationship with the regulatory authorities.
  • Environment shaping and advocacy activities within country / region
  • Primary Responsibilities :

  • Lead and manage the RA team in the development of regulatory strategies to support the registration of products, line extensions, clinical trial applications, new, major variations and lifecycle management.
  • Ensure that regional RA teams provide strategic regulatory input into WSR global regulatory strategies, thus providing optimal support for meeting local business objectives.

  • Maintain licenses (e.g. Marketing Authorizations) in compliance with local regulations by ensuring that corporate regulatory processes, SOP’s and systems (e.
  • g. CMC change control, product labelling, etc.) are in place, and that the RA staff (permanent and contract) are properly trained in these systems and procedures.

  • Oversee and manage the completion of CTA, NDA and Lifecycle (LC) submissions and approvals as per established WSR-I performance metrics and Alliance Partner model.
  • Responsible for ensuring that all regulatory activities (new product submissions, clinical trial applications, existing licenses, etc.
  • are compliant with local regulations, requirements and practices.

  • Provide input to the relevant stakeholders for the development of products in-line with business objectives, ensuring strategies are adequately reflected in relevant country plans (e.
  • g., business development or manufacturing supply) and alignment is achieved between regulatory activities and relevant country business / commercial plans.

  • Provide consultative and intelligence support to internal stakeholders. Advise where necessary, on the development of responses to regulatory queries, including coordination on the receipt, distribution and response to regulatory queries on assigned projects, consistent with departmental procedures.
  • Responsible for the development, leadership and performance management of the direct reports team to achieve company objectives.
  • Develop and enhance the capabilities and capacities of the RA teams through the identification and implementation of training and development needs.

  • Develop strong partnerships with in-country and regional teams (e.g. Country Managers, Medical, Commercial, Supply Chain) and above country WSR Therapeutic Area and Regional Teams to facilitate the development and implementation of registration strategies to expedite the registration of new products, line extensions and life-cycle optimization.
  • Provide strategic contribution to the WSR-Innovative leadership.
  • Contribute to change management and continuous improvement projects (Regulatory Operational Excellence) within country.
  • Responsible for developing and supporting relationships with key external agencies. Support the Health Authority interface throughout the development and lifecycle of a product.
  • Support long-term and positive relationship characterized by integrity, quality, compliance and leadership. Facilitate meetings and participate in negotiations with regulatory authority as necessary.

  • Active participation in regional trade organization and effective communication to key stakeholders of key issues that could impact regulatory strategies or the business.
  • Understand regional regulations and developing trends in the local regulatory environment and provide assessment of the impact to key stakeholders.

    Leverage regulatory intelligence / landscape knowledge to support the development and implementation of regulatory and business.

    Regulatory Authority Liaison :

  • Serve as the primary point of contact for the Health Authority and be actively involved as a Liaison Officer for the Health Authority.
  • Be required to travel to Islamabad as needed to submit and manage registration applications as well as address arising registration related and policy matters.
  • People Management :

  • Foster continual learning to promote regulatory excellence.
  • Manage the performance of direct reports to achieve agreed objectives.
  • Identify and address training and developments needs to encourage and talent development and succession planning.
  • Keep team continuously engaged to retain / attract talent.
  • Project Management :

  • Oversee and / or facilitate strategic process improvements initiatives.
  • Ensure product strategies, submission and approval time lines.
  • Technical Skill Requirements :

    Qualifications (i.e., preferred education, experience, attributes) :

  • Scientific degree (preferably a pharmacist). A higher degree (MS or PhD) may be an advantage
  • Pharmacist degree may be mandatory in some countries
  • Appropriate Regulatory Affairs experience minimum 5-10 years is preferred.
  • Management Degree (Undergraduate or MBA) may be an advantage
  • Proven ability to consistently deliver to time, cost and quality standards.
  • Fluent in English written and spoken communication skills
  • Demonstrable experience across the Drug, Discovery, Development and commercialization lifecycle, with proven examples of contribution.
  • Proven ability to manage complex regulatory issues.
  • Proven ability to consistently deliver to time, cost and quality standards.
  • Regional regulatory experience including knowledge of CTA’s and NDA submission processes and product life cycle management activities.
  • General management experience and previous line management and leadership experience at senior management level is essential.
  • Demonstrable experience of effective delivery in a complex matrix environment
  • Competencies :

  • Knowledge of the Regional and Global regulatory environment and how this impacts regulatory strategy and implementation.
  • Knowledge of drug development practice, rules, regulations and guidelines.

    Communicates effectively using a variety of mediums appropriate to the setting.

    Can negotiate skillfully in tough situations with both internal and external groups. Can be direct and forceful as well as diplomatic.

    Problem Solving

    Understands Business and Financial Environment

    Understands and develops mitigation strategies for issues and drivers impacting the Pharmaceutical industry

    Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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