Job Description
JD template Version: 02; Effective Date: 16-Sep-19 Page 1 of 3
Role: Senior Manager/Associate Director, Regulatory Affairs
Job Overview
Overall responsible for completing the allocated projects per the agreed objectives while meeting critical milestones and related communication metrices. Manage diverse regulatory affairs projects related to supply chain management, site transfer, legal entity name change, and their impact on stock-keeping units (SKUs). The ideal candidate must demonstrate strong project management, stakeholder management, communication, negotiation, and technical skills to address the diverse regulatory requirements of Pharma/OTC products.
Functional Responsibilities
1.
Delivery
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Manage technical projects involving site transfer, legal entity name changes etc.
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Lead or actively participate in site-to-site manufacturing transfers by providing critical know-how as well as technical information and documents besides supporting questions relevant to the CMC sections to achieve successful new site registration, if needed, within compliance and agreed timelines.
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Partner and coordinate with supply planning and distribution centers.
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Manage/coordinate change initiatives that require cross-functional coordination which may include a mass change in packaging artwork to implement new guidance, livery change, MAH address changes, or similar.
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Review and approve relevant technical documentation with reference to the product’s MA including product quality documents, certificates of analysis, stability data, BMRs, PQRs, as well as risk assessments.
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Build and maintain relationships with key personnel both internally and with alliance partners.
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Play a key role in stakeholder management and ensure appropriate use of communication channels to strengthen relationships with the stakeholders.
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Lead cross-functional teams in preparing for and facilitating consistent internal and external communications and partner interactions utilizing governance structure.
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Develop team charter, and implementation plans. Conduct risk assessments, develop and implement contingency plans to accommodate unforeseen events and changes in strategy.
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Provide thoughtful direction and counsel to team members on strategy and approach based on a deep understanding of the projects and partners.
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Prioritize issues and brainstorm solutions to relationship issues proactively, as well as conduct - analyses to identify and implement proactive mitigation strategies.
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Manage high level risk by making complex judgments, develop innovative solutions including proactive risk management and mitigation.
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Demonstrate application of formal project management capabilities. Communicate effectively across disciplines and department/partners to keep the key stakeholders informed of project status, issues, conflicts, and mitigating actions as necessary.
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Build strong partnerships and provide leadership to challenge and influence stakeholder requirements and optimize supply chain processes globally.
Job Description
JD template Version: 02; Effective Date: 16-Sep-19 Page 2 of 3
2.
Training compliance
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Ensure that all training (both internal and client training) are successfully completed in a timely manner
Note: The above statements describe the general nature and level of work to be performed and are not an exhaustive list of all responsibilities required for the position.
Education
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M.Pharm/MSc/MBA besides appropriate project management training certification or qualification.
Skills and personal attributes
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Proven leadership ability with excellent communication skills including listening, verbal presentation, and written.
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Strong Strategy development and planning skills coupled with necessary knowledge of pharmaceutical manufacturing and supply activities.
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Strong project management skills with the ability to handle complex situations with opposing priorities and an ability to influence others are essential.
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Strong issue identification and problem analysis and solution development skills.
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Ability to communicate effectively to international cross-functional stakeholders and management.
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APICS, Process Excellence, or PMP certification are a plus.
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Experience with data analytics and visualization tools; and/or project management collaboration platforms is a plus.
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Ability to work in a fast-paced, cohesive, collaborative team-oriented work Environment.
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Commitment to highest quality outputs, including meticulous attention to detail.
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Enthusiasm and pro-activity
Minimum Work Experience
Minimum 12 years of regulatory affairs and project management experience in the relevant area (e.g. Pharma, Consumer, Medical device):
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Significant experience in site tech transfer including wide exposure to pharmaceutical manufacturing, QC testing, and packaging including serialization.
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Experience of working in a regional/global setting, or experience in large-scale business transformation projects.
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Proven track record of successful Project management and execution including successful Site Technical Transfer
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Global exposure to manufacturing, registering, and distributing pharmaceuticals.
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Thorough understanding of change management processes and regulatory requirements
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Project management experience and/or certification in project management is preferred.
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Thorough understanding of the drug development process for all phases of pharmaceutical development and applied comprehensive understanding of regulations
Job Description
JD template Version: 02; Effective Date: 16-Sep-19 Page 3 of 3
and guidelines to enhance
the probability of regulatory success and regulatory compliance.
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Strong problem-solving skills to evaluate technical information and identify appropriate regulatory actions.
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Proven ability to manage/support multiple project teams and identify and resolve regulatory issues.
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Demonstrated experience of Global Regulatory Affairs processes, both pre- and post-marketing is highly preferred.
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Successful experience managing or leading global and/or virtual teams is preferred, especially if done within a matrix organization.