Functions as an experienced CMC strategist & reviewer for the Life Cycle Management (LCM) activities of assigned products and/or projects providing regulatory assessments and developing regulatory strategies for global markets including US/EU/APAC/LATAM & AfME regions; Accountable for assigned projects and activities, completing work within assigned product portfolio. Develops resolution proposals for regulatory CMC issues with the stakeholders.
Reviews proposed CMC changes for completeness and accuracy, interpret CMC regulatory requirements , develops strategies, assess risks and develops contingency proposals. Use technical and scientific knowledge to conduct the analysis of CMC submission documentation.
Responsible for the authoring of CTD sections (Module 3 and QOS) and review of CMC documentation, coordination and management of global submissions, including the assessment and management of commercial license status, maintenance of product compliance and management of change control; Management of Queries; Works almost independently
Job Responsibilities:
Functions as an experienced CMC Strategist responsible for development and execution of regulatory strategies for the submissions and compliance activities of assigned products; Collaborates with Cross Functional Teams (RRHS/PCO/RCM/Site CNM) and GRS-CMC to ensure the deliverables. Has advance knowledge/understanding of the principles and concepts of the process being followed, to perform the below listed activities but not limited to :

• 
  Primary accountable for CMC programs for the assigned products, managing daily delivery of regulatory and strategic activities, including post-approval changes, and ongoing compliance of commercial products in the portfolio for global markets including US/EU/APAC/LATAM & AfME regions
• 
  Responsible for managing end to end assessment of CMC in collaboration with global PGS site CNMs and ESQ COQAs, Regional Regulatory Hub Strategists across global regions, RCMs and HSMs.
• 
  Provides and drives strategic and operational global CMC regulatory direction and documentation for assigned products covering post approval activities.
• 
  Applies knowledge and expertise in developing & driving/implementing regulatory strategies, authors CMC submission to global regulatory agencies, assesses risks and develops contingency/mitigation plans.
• 
  Assess scientific opinions and assist in developing regulatory strategies and documentation.
• 
  Operates independently even in ambiguous situations
• 
  Acts as the global CMC representative within cross-functional project teams, involving the interpretation of regulations and guidelines and the assessment of global implications for strategic CMC decisions.
• 
  Represent CMC for the assigned products during Health Authority interactions either directly or indirectly in conjunction with Global Regulatory Affairs Teams.
• 
  Resolve issues and manage regulatory risks within project teams. Investigates opportunities for regulatory innovation / promote the use of novel regulatory approaches within project team to resolve issues and problems.
• 
  Reviews the variation CMC packages authored & compiled by team colleagues and provides recommendations to enhance the scientific quality in submissions. Assess scientific opinions and assist in developing regulatory strategies and documentation.
• 
  Recommend solutions for issues of various complexities and escalates issues with significant business impact where necessary.
• 
  Contribute to the completion of projects, manage own time to meet agreed targets and
• 
  Escalates delays in timelines and contributes to the identification and mitigation of risks; flags identified risks to the CMC appropriate leadership
• 
  Makes decisions and ensures resolution of issues and manages regulatory risks for complex changes even in ambiguous situations based on the depth of knowledge
• 
  Ensure compliance to Pfizer's training activities (e.g. functional, compliance-related, HR policies) & individual development plans, participate in cross-disciplinary forums & learning opportunities, demonstrating & modeling adherence to all Pfizer behaviors & values, embracing & complying with
• 
  Utilizes Pfizers systems, i.e. PEARL, GDMS, PDM, SPA, etc, as appropriate.
• 
  Support team in the development of regulatory strategies to support registrations.
• 
  Provides mentoring/training support on technical aspects of the team (end to end, from strategy building through authoringsubmissions),Pfizer System and processes to junior staffs.
  Preferred Education:
  Minimum - Postgraduate in Pharmacy / Science.
  Preferred Experience:
  Minimum 15 Years in leading independently in the Regulatory Affairs function in a reputed Pharmaceutical Organization. Advanced knowledge of global regulatory initial and /or and LCM post approval submissions.
  Preferred Attributes:
• 
  Excellent oral and written English communication skills. Good conceptual, analytical, problem solving, reasoning and organizational skills. Should be change agile and have ability to work in highly matrixed environment. Attention to detail and accuracy required.
• 
  The candidate ideally should have experience with effective teamwork, collaboration, and communication, and demonstrated leadership ability.
• 
  Must be able to prioritize with independently/minimal guidance. Ability to handle multiple projects with good prioritization skills. Willingness to work flexible hours.
  
• 
  Technical Skills:
• 
  Sound understanding of drug development regulatory processes and requirements for defined market(s) and able to interpret and apply to projects.
• 
  Strong knowledge on the Regulatory requirements during both development and life-cycle management phases for US, Europe and other major markets and has expertise to oversee preparation and submission of complex regulatory submissions. Knowledge on current regulations and filings requirements for post approval requirements is preferred.
• 
  Sound knowledge on ICH Quality Guidance.
• 
  Competency in understanding and interpreting regulatory requirements and emerging regulatory landscape.
• 
  Ability to manage complex regulatory issues and business processes; to manage a group of established products; to consistently deliver to time, cost, and quality standards; to partner successfully with global stakeholders to achieve objectives.
• 
  Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format, including to senior management.
• 
  Ability to comprehend and summarize complex technical data.
• 
  Ability to utilize flexible approaches to negotiate skillfully in tough situations with both internal and external groups. Gains trust quickly of other parties to the negotiations.
• 
  Adequate level of knowledge on general standards, processes and policies of Pfizer/Pharmaceutical manufacturing Industry.
• 
  Aware of external regulatory environment, including competitor intelligence and regulatory actions to assist regulatory strategy development.
• 
  Ability to identify inconsistencies and deficiencies in technical data and escalates to management for resolution.
• 
  Thorough knowledge and experience of drug development practice, rules, regulations, and guidelines.
• 
  Demonstrates knowledge of key processes, procedures and tools.
• 
  Ability to develop projects plans to support short-term & long-term operational goals and contribute to the development of global regulatory initiatives with appropriate supervision.
• 
  Demonstrates a high level of integrity in decision making on regulatory issues in line with company values.
• 
  Fosters a culture in which uncompromising integrity and accountability is the standard.
• 
  Competent working knowledge of computer-based systems such as Microsoft Office, controlled documentation systems (e.g. Documentum).
• 
  Ability to learn and navigate tracking/change control systems, compliant and consistent use of systems (including GMP validated systems) and willingness to support others in system use.

Work Location Assignment: Flexible

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