SEMEEN SAMREEN

+91-817**-***** adue5r@r.postjobfree.com https://www.linkedin.com/in/semeen-samreen-56bb9045/

PROFILE SUMMARY

A highly-skilled professional with eight-plus years of experience in the Pharmaceutical industry. Hands-on experience in CMC data/documents handling preparation, review and submission of dossier, including registration, renewals, and filing of variations in Europe. Proven ability to manage Regulatory Affairs tasks to offer top-notch CMC dossiers, CMC post-approval activities (variations) documents, and Affairs business priorities. A Significant contribution to Module 1 documents, including life cycle management of products in the development portfolio. Competent in Gap Analysis, Compilation of Module 3, Dossier Preparation, and Variations. Outstanding analytical abilities, problem-solving, decision-making, and interpersonal skills

CORE COMPETENCIES

Regulatory Affairs, Life Cycle Management

Understanding of ICH, FDA, and other regulatory requirements

Microsoft Office - Word, Excel, Access, and PowerPoint

Internet Search Engines

SKILLS

Regulatory Affairs & Compliance

Pharmacology

Pharmacovigilance

Good Manufacturing Practice (GMP)

Dossier Preparation

Life Cycle Management

CMC Data/Documents Handling

Product Registration

Clinical Trials & Research

Quality and Analytical Data Review

New Projects Review

Regulatory Submissions

WORK EXPERIENCE

Novartis, Hyderabad, India Dec 2020 - Till Date

Senior Regulatory Coordinator

Working with management oversight to contribute to Module 1 documentation, especially for the life cycle management of products in the development portfolio. Ensuring that all requirements meet submission-related operations and that timely submissions comply with rules by conducting monthly reconciliation

Offering regulatory and compliance support for significant line expansions and development projects through registration, approval, and post-approval obligations

Supporting regulatory managers with tasks connected to submissions for regulatory responses to health authorities, including compilation and release of submissions to regulatory agencies

Creating a plan for product registration, carrying it out in line with the plan for launch and registration, and keeping it licensed following local laws and global compliance policies

In coordination with Global RA and associated CO departments, review new projects and design a development strategy (timeline, etc.)

Accountable for critical analysis of data, assessment and early issue identification, and creation of project plans

Fostering and sustaining positive relationships with both internal and external partners

Freyr Solutions, Hyderabad, India Apr 2014 - Dec 2020

Senior Regulatory Affairs Associate

Accountable for the preparation, review, and submission of dossiers, including registration, renewals, and filing of variation in the Europe region, including CMC data/document management

Acted as a functional representative on projects involving the allocated marketed product portfolio as well as new product development for lifecycle management activities like site transfers, renewals, etc., to ensure prompt delivery of essential regulatory materials

Initiated a small process improvement effort and contributed to massive and more substantial process changes

Actively identified any content, quality, or timeliness concerns with the source documents, as well as any other possible authoring problems that could affect the quality or timeliness of the submission

Provided CMC evaluations for potential changes as requested and follows up to ensure regulatory compliance

Handled the task entailing Gap Analysis, Compilation of Module 3, Dossier Preparation, and Variations

Cooperated with the RA to develop a plan for the quick registration of products from established lines and new chemical products with the FDA, EMA, and other international regulatory agencies

Provided assessments of regulatory changes within the system and filed strategy guidance

Kept track of the high-level regulatory trackers that offer information on the work's status and specifics

Highlights:

Contributed to the assessment of submitted documents and developed the content of regulatory documents, working with other functions as needed

Offered regulatory direction to aid in business development

Solo acquisition of different regulatory documents required for submissions in cooperation with other organizational functions

Created CMC sections for post-approval operations such as renewals, change controls, and dossier preparation for the EU area and assembling variants (Type IA, IB, and II)

Analytical and quality data review following pharmacopeia, specifications, batch records, stability data, finished product, and packaging material data for dossier compilation

Handled certificates as renewal documents, including certificates for pharmaceutical products, GMP certifications, manufacturing authorizations, and TSE certificates, to support RA business operations for marketed product portfolios

Supported Renewal activities by submitting the necessary declarations, documentation, and expert assistance for clarifications in alignment with various stakeholders

Coordinated with several HAs, including Swiss Medical and Consular Services, to obtain certificates for the specified portfolio

Prepared regulatory applications for new products and renewals of registered products, supported registration of applications, including new products and renewals, in compliance with applicable laws & regulations, and maintained registration in accordance with standards

Upkeep a current country requirement list and planning through the use of need-based surveys

EDUCATION

Master of Pharmacy (Pharmacology) from St. Mary’s College of Pharmacy, Affiliated with JNTUH, India - 2014

Bachelor of Pharmacy from Jyothismathi College of Pharmaceutical Sciences, Affiliated with JNTUH, India - 2012

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