FARUQ MOHAMMED
Hanumakonda
Summary
Regulatory specialist with proven track record in navigating complex regulatory landscapes. Adept at developing and implementing compliance strategies that align with industry standards. Valued for strong team collaboration and delivering results in dynamic environments, showcasing skills in regulatory analysis and policy development. Proven ability to navigate complex regulatory environments, ensuring adherence to industry standards and guidelines. Skilled in risk assessment, documentation, and team collaboration to drive impactful results. Renowned for adaptability, reliability, and precision in meeting evolving regulatory requirements.
Overview
10
10
years of professional experience
Work History
Senior Regulatory Professional
Novo Nordisk
07.2024 - Current
- Global CMC Regulatory Strategy and Compliance: Spearheaded the formulation and execution of innovative regulatory strategies to maximize business outcomes while adhering to compliance requirements.
- Submission Leadership: Directed and implemented comprehensive global CMC submission activities, including planning, authoring, reviewing, coordinating, and submission for assigned projects and products.
- Documentation Management: Oversaw the identification, negotiation, and delivery of technical source documents, ensuring content accuracy, quality, and adherence to timelines for global submissions.
- Technical Authoring and Review: Authored and reviewed high-quality CMC documentation for Health Authority submissions, aligning with global regulatory strategies, contemporary trends, and guidelines.
- Regulatory Compliance: Ensured technical consistency and regulatory adherence, meeting established timelines and electronic publishing standards.
- Risk Management: Prepared and communicated CMC risk assessments, contingency plans, and lessons learned for major submissions, escalating concerns to management when necessary.
- Health Authority Interactions: Led engagements and negotiations with Health Authorities, defining objectives, preparing briefing materials, coordinating rehearsals, and devising risk mitigation strategies.
- Incident Reporting: Managed reporting of technical complaints, adverse events, or special case scenarios related to NN products within 24 hours.
- Sample Distribution: Facilitated the distribution of marketing samples, as required.
Senior Specialist - Global Regulatory Affairs
Sandoz
08.2021 - Current
- Prepared new submissions and regulatory maintenance, including variations and renewals.
- Planned submission resources to ensure timely publication and dispatch of documents.
- Supported regulatory teams throughout product development and post-marketing commitments.
- Provided strategic input to development and commercial teams to address supply challenges.
- Managed stakeholders and planned projects to scope regulatory initiatives by product and geography.
- Assisted in creation and maintenance of business processes within Regulatory IT systems.
- Proactively identified future needs for digital transformation to enhance core processes.
- Monitored emerging technologies such as AI and ML to assess potential impacts.
Executive in Global Regulatory Affairs
Viatris
11.2017 - 07.2021
- Led global team of four associates on Divestment project initiatives.
- Participated in Global Regulatory Strategy discussions, ensuring effective implementation.
- Prepared initial submissions and CFT reviews for Pre-approval RA activities.
- Directed WHO and Emerging Markets CMC submission activities for assigned projects.
- Evaluated and prepared variation applications for US, Europe, WHO, and Emerging Markets.
- Responded promptly to queries from health agencies during interactions.
- Drafted requalification, renewal, and product expansion dossiers and tender documents.
- Reviewed labeling and approved artwork components for new submissions.
Officer - Site QA & Regulatory Affairs
Mylan Laboratories Limited
08.2015 - 10.2017
- Initiated, reviewed, and tracked CMS Change Proposals through completion via Track wise.
- Coordinated with Global Quality and Regulatory teams for effective change routing and implementation.
- Tracked Pharmacopeial updates, implemented changes, and performed gap assessments.
- Prepared Risk Assessment Reports for change controls, assessing impacts on critical quality attributes.
- Achieved timely closure of Change Controls and related CAPAs while investigating quality issues.
- Reviewed and approved CMC documents, supporting vendor qualification for raw materials through data evaluation.
- Supported operational compliance activities, including tracking commitments and managing documents.
Education
M. Pharmacy - Pharmaceutics
IIT(BHU), Varanasi
01.2015
B. Pharmacy - undefined
Kakatiya University
01.2012
H.S.C. (Class XII) - undefined
Board of Intermediate Education
01.2007
S.S.C. (Class X) - undefined
Board of Secondary Education
01.2005
Skills
- Regulatory CMC & Strategy
- Global Labelling
- Operational Excellence
- Regulatory IT systems
- Team Management
- Regulatory submissions
- Auditing expertise
- Regulatory intelligence
PERSONAL DETAILS
English
Hindi
Telugu
Accomplishments
- Led onboarding trainings for Regulatory Affairs Departments during Mylan’s acquisitions of MEDA (ROW markets) and Jai Pharma.
- Played a key role in merging, redesigning, and validating Quality Management System tools post-acquisition.
Timeline
Senior Regulatory Professional
Novo Nordisk
07.2024 - Current
Senior Specialist - Global Regulatory Affairs
Sandoz
08.2021 - Current
Executive in Global Regulatory Affairs
Viatris
11.2017 - 07.2021
Officer - Site QA & Regulatory Affairs
Mylan Laboratories Limited
08.2015 - 10.2017
B. Pharmacy - undefined
Kakatiya University
H.S.C. (Class XII) - undefined
Board of Intermediate Education
S.S.C. (Class X) - undefined
Board of Secondary Education
M. Pharmacy - Pharmaceutics
IIT(BHU), Varanasi
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