Manager - BTxPS Design Control Reg Support

ROLE SUMMARY

• Functions as a senior regulatory team member for BTx regulatory support team within India strategy group that will provide support to documentation related to design control (V&V) to the global Biotherapeutics PharmSci organization and will support the technical authoring related to regulatory submissions. Consequently, the candidate is expected to effortlessly work across different analytical functions, projects, and geographies to ensure the deliverables of the team.
• The qualified candidate will be a senior level scientific professional having end-to-end understanding on biologics/pharma product development seeking to lead the industry in technologies applied to advance biotechnologically-derived products to the market through innovation.

• Functions as a senior team member and be involved in cross-functional teams across many Pfizer sites in the United States, Europe, India and Japan.
• Responsible for the planning, coordination, execution, and communication of design control documentation responsibilities related to regulatory filing.
• Identify, communicate, and develop strategies to improve combination product systems.
• Ensure that combination product development activities are compliant with quality and regulatory standards - both internal and external.
• Individuals in this group will be the primary authors, reviewers, and approvers of regulated documents such as method validation reports, protocols, workbooks, transfers, risk assessment documents and regulatory submissions (BLAs, MAAs,) to support development and execution of global regulatory strategies, submissions and compliance activities for business continuity supporting BTx PharmSci project portfolio
• Define, plan and Lead design control and risk management activities for combination product development programs, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.
• Provide input and support for design validation, including but not limited to human factors engineering assessments.
• Support the generation of all regulatory submission data and content for assigned device projects.
• Effective Technical writing and editing expected, applied to regulatory documents and supportive scientific / technical reports related to MDCP Design Control
• Support device design and manufacturing investigations from devices used in clinical trials and commercial manufacture.
• Support internal and external audits of the DPDD Quality System.
• The successful candidate will be involved to ensure the proper and timely execution of all documentation aspects of the design verification and validation required as per combination product regulations.
• Ensures that regulatory resources are optimized and working in an efficient manner.
• Provides technical / functional leadership to the teams, negotiates with and influences management, cross functional teams, colleagues and external partners to ensure the deliverables are met.
• Provides adequate support and guidance to the team in terms of being resourceful on technical and regulatory knowledge.
• Ensures resolution of issues and manages risks within project. Investigates opportunities for novel approaches to resolve issues and problems.
• Ensures effective coordination and collaboration with stakeholders to ensure key submission deliverable
• Responsible for ensuring compliance to Company's submission standards, policies and procedures for self and team.
• Contributes to the development of internal policies, processes and procedure
• Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel to ensure contemporary standards in authoring are met.
• Recognizes development needs and identifies/creates development opportunities (e.g., special assignments) for colleagues Develops a talent base and anticipates development needs within the area of responsibility.

• M.S. /M.E./Ph.D. in Biotechnology, Biochemistry, Biomedical, Mechanical, Materials, Chemical Engineering; or other related discipline

• Minimum 10 Years of experience in Biopharmaceutical Industry with interdisciplinary drug product or combo product development knowledge.
• Working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, ISO 11040 and the EU Medical Devices Directive.
• Working knowledge of EN 62366 and EU Medical Devices Regulation
• Knowledge of current US and global Regulations, FDA and ICH guidance, ISO standards for syringes/injectors, luer connectors, and quality system regulations (Part 4) for combination products
• Experience in Design Controls for Combinations Products and device risk management preferred
• Familiar with Human Factors Engineering - Usability Engineering.
• Understand project management methodologies and capable to provide technical leadership for projects.
• Familiar with device assembling manufacturing process
• Ability to perform mathematical calculations and ability to perform complex data analysis.
• Experience / knowledge with technologies focused on analysis of biomolecules and conjugates including but not limited to chromatography, electrophoresis, spectroscopy and other high -throughput analysis methods.
• Experience working in a regulated environment (e.g. GLP, cGMP).
• Proven record of strong technical skills and scientific expertise in regulatory authoring
• Proven record of delivering results in a fast-paced environment and effective communication to project teams and external partners (e.g. regulatory authorities).
• Sound interpersonal, collaborative and consensus-building skills, including diplomacy to negotiate conflicting priorities.
• Administrative capabilities to build motivate and manage a group. Able to mentor less experienced staff; Clearly Assigns responsibility for tasks and decisions, sets clear objectives and measures, monitors process, progress and results