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Post : Director Analytical Regulatory Strategy & Compliance
Job Description
• Develop and define the technical/analytical strategy regarding the application of global regulatory requirements and Rest of World / Emerging technical trends (e.g. China, Russia, Brazil, Korea, …) in product registration and post-approval change submissions for SM VS. This will be accomplished by partnering with R&D and JSC functions to understand and align on the pharmaceutical regulatory requirements.
- Implement the strategy by deploying mechanism and updating tools such as R&D roadmap, playbook etc. that assist PDMS teams to ensure product launch excellence and global / national compliance.
• Strategically collaborate with internal stakeholders and external industry groups on any effort to influence the shaping of regulatory guidance, pharmacopoeia and analytical regulations, and to advocate on behalf of Janssen and the industry with these regulatory bodies and compendial authorities.
• Identify key strategic conferences for attendance and coordinate AD SM representation to develop a technical networking/benchmarking/influencing strategy.
• Serve as the “Directly Responsible Individual” in Janssen for all (including but not limited to USP, Ph.Eur., JP, ChP, etc) compendial updates and interactions.
- Lead and drive the development and execution of high quality, fit for purpose, cross-functional Compendial Vigilance and Compliance (CV&C) strategy at company level for PDMS incl. small & large molecules, PCD and Vaccines.
- Accountable for the review of compendial revisions (proposed and official) to drug products, APIs, excipients, test methods, and general chapters as published by the global / national pharmacopoeia, and facilitate company-wide reviews of these changes.
- Lead a Compendial team of consultants (based in Mumbai, India and North America, US) and work closely with internal teams to ensure effective implementation planning and compliance with compendial requirements, including new and revised analytical methods and specifications and implementations as needed.
- Work closely with stakeholders to coordinate the submission of new and revised monograph proposals to the pharmacopoeias for Janssen APIs and products, extending Janssen’s initiative for prospective monograph harmonization for small & large molecules.
- Provide compendial guidance and expertise throughout Janssen (PDMS, JSC, CMC RA). Provide ongoing training to SME’s and users as needed. Respond to questions and issues that arise within Janssen regarding any of the pharmacopoeias.
- Manage the CV&C metrics framework to drive performance and measure company compliance.
- Conduct diagnostics and benchmarking to identify gaps and opportunities to achieve additional value in the CV&C area.
• Support, as analytical expert and strategist from a global perspective, specific EMAX countries to safeguard strategic products in view of impacting guidelines as they emerge. E.g. support the Janssen China organization in developing an adequate dossier for Generic Consistency Evaluation in pursuit of Reference Listed Drug (RLD) designations for their strategic commercial products. Search for and collect relevant historical product development information, data from global supply chain sites and co-ordinate additional analytical activities within global AD to define the strategy and build the file. Prepare and coach the local team on the analytical strategy for their interactions with the authorities.
• In addition, drive adherence to PDMS development and governance processes, including strategic contributions on level 1 & 2 Technical Project Reviews at various development / life cycle stages to ensure analytical compliance with current regulations, governing compendia, and company standards. Capture learnings for rapid dissemination and uptake by other project teams.
• Act as an Analytical Integrator for more complex late development pharmaceutical product portfolio & lifecycle programs such as line extensions, new filings after first NDA/MAA, etc. Act as a technical mentor/coach to elevate AD LCM organization.
• Develop strategies, manage budget and implement activities to achieve departmental goals; contribute to improve business/work processes across organizations. Drive and enable (cross-functional) continuous improvement, and lead or contribute to compendial and regulatory intelligence special projects, as needed.
• Assist and coordinate activities in preparation of inspections. Spokesperson during audits and inspections for assigned portfolio / roles.
Candidate Profile
• Advanced (Ph.D.) degree in Chemistry, Pharmacy, Biochemistry and broad global experience within drug development and lifecycle support for small molecules. At least 12 years relevant business experience, of which a significant part (at least 8 years) with regulatory procedures across the world.
• Knowledgeable about most aspects of pharmaceutical technology (small molecules) with strong scientific understanding of pharmaceutical production, galenical formulations, manufacturing and packaging processes of pharmaceutical products, analytical testing in pharmaceutical drug release, and stability studies. Knowledge of biologics is advantageous. Insight in product quality assurance/control, and product development and manufacturing an asset.
• Comprehensive knowledge of global regulatory requirements and guidelines and of the submission process is preferred. Experience with responding to health authority questions related to analytics and specifications is required.
• Good network of industry personnel, academic & pharmacopoeial institutions.
• Extensive technical and regulatory experience with proven track record of successful strategy development and implementation.
• Demonstrated ability to author, review and approve scientific reports and sections of regulatory filings.
• Ability to work independently, handle multiple & complex tasks in an organized and productive manner, and respect commitments is required.
• Experience in leading cross functional project teams and influencing members and senior management is required. Demonstrated record of customer focus and being results driven.
• Good communication skills (intercultural & interdisciplinary communication). Cooperate across functions, business units and geographical boundaries.
• Strategic thinker; strong analytical and pragmatic problem-solving skills and business acumen. Ability to lead complex matrixed teams and experience in influencing and working with/presenting to senior leadership in PDMS, JSC and external health authorities.
• Well organized, creative, independent, self-motivated individual with excellent presentation, written, and oral communication skills (English is preferred).
Additional Information:
Experience: 12 years
Qualification: Ph.D in Chemistry, Pharmacy
Location: Belgium (Beerse), US (North America)
Functional Area: R&D
Industry Type: Pharma
Requisition ID : 1805649341W
End Date: 25th May, 2018
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