Job Description

ROLE SUMMARY

• Develop CMC regulatory strategies, submissions and compliance activities for pharmatherapeutic development programs and commercial products supporting PBG products registered and marketed within the Asia Pacific (APAC) or Africa and Middle East (AfME) or European Union (EU) region, with supervision.
• Provide operational global CMC regulatory support and documentation for assigned projects/products covering initial registrations and approval/post approval activities of medium complexity/risk. Assembles CMC information for submission to APAC or AfME or EU region regulatory agencies and supports CMC strategies with supervision. Maintains and tracks submission and approval statuses. Perform regulatory fact finding for the preparation of CMC information for submission to global regulatory agencies.Maintain CMC systems and perform data entry.
• Assist cross-functional project teams by scheduling meetings, taking notes and tracking action items independently

ROLE RESPONSIBITIES

• Sound understanding of regulatory processes and requirements for defined market(s) and able to interpret and apply to projects. Aware of external regulatory environment, including competitor intelligence and regulatory actions to assist regulatory strategy development. Able to identify inconsistencies and deficiencies in technical data and escalates to management for resolution. Assesses scientific opinions in developing regulatory strategies and documentation. Knowledge of drug development practice, rules, regulations, and guidelines. Demonstrates a developed knowledge of key processes, procedures and tools. Maintains compliance in regulatory systems.
• Independently manages projects, makes decisions and executes upon strategies and plans with minimal oversight from manager. Recommends solutions and escalates issues with significant business impact where necessary. Supports team in the development of regulatory strategies to support registrations. Demonstrates a high level of integrity in decision making on regulatory issues in line with company values.
• Responsible for authoring 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 of moderate complexity with appropriate supervision.
• Fosters a culture in which uncompromising integrity and accountability is the standard.
• Makes decisions to resolve moderately complex problems in standard situations. Makes decisions within guidelines and policies.
• Understands the fundamental business drivers for the company. Uses this knowledge in own work.
• Ability to collaborate effectively across a network of other stakeholders, partners and customers, to compile high quality CMC inputs and aiding the compliance of the Pfizer pharmatherapeutic product portfolio. Assists in the development of resolution proposals for moderate regulatory CMC/information management issues in support of project/program stakeholders. Displays a willingness to make appropriate and timely decisions, exhibits sound and accurate judgment.
• Ability to develop projects plans to support short-term operational goals and contribute to the development of global regulatory initiatives with appropriate supervision.

QUALIFICATIONS

• Postgraduate in Pharmacy or equivalent Sciences degree. Must have a minimum of 5 - 7 years regulatory experience in new registrations / post approval changes. Experience with diverse dosage forms, particularly sterile products / Solid Orals, is desirable.
• Candidate is required to have a basic understanding of manufacturing / pharmaceutical sciences / the pharmaceutical industry with an understanding of drug development/commercial manufacturing of pharmaceutical products with technical writing skills. 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.

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