Nikita Varshney

• Leading regulatory expert in cross-functional project teams for entire product pipeline (from ideation to feasibility phase).
• Global filing strategist: Defining regulatory strategy for any new product submission, product, geographic expansion, or life cycle management.
• Communicating regulatory insights and suggestions to help make well-informed decisions; to identify best markets and sequence for launching products.
• Authoring Regulatory Intelligence reports which incorporates key milestones and decision points; regulatory objectives, obstacles, and regulatory landscape, and characterize risks to potential success in delivering a specific regulatory outcome.
• Conducting competitive and product intelligence research that drives strategic decision-making about product development and marketing strategies.
• Identifying risks to effectively plan mitigation strategies for product development based on current requirements and precedents.
• Preparation for regulatory meetings and briefings: Developing a precise, well-organized briefing document presenting a clear company position with a targeted set of questions that elicits detailed responses/discussion with the HA.
• Shaping future policies and regulations and External engagement: Continuous monitoring of the regulatory landscape as well as interpreting and evaluating the implications of draft legislations, regulations, guidelines, and policies under public consultation.
• Health Authorities (HA) Deficiencies Management: Devising a repository of experience from past HA queries to predict possible HA queries based on submission type/therapeutic area/similar markets and propose the best suitable resolutions and standardized approach.
• Regulatory mapping of available precedence, internal systems and procedures, trend analysis of variations.
• Dissemination of Regulatory Intelligence as dictated by business requirements:

Regulatory Surveillance reports – Monthly survey on the new / updated regulatory information, trends and real-time alerts in regulatory changes, in the form of newsletters or emailers or high-level summaries for leadership team.

Regulatory Intelligence reports – Roadmap for the product development in a particular geography.

Discussion boards – Impact assessments of draft guidelines, legislations, and policies on existing product portfolio

Regulatory mapping reports – Consolidated comparative regulatory requirements on hot topics for the international markets in close co-ordination with regional regulatory affiliates.

• Regulatory intelligence support and guidance to cross-functional teams, globally. Providing responses to ad-hoc information requests and other regulatory enquiries from team.
• Project Management Regulatory support to internal and external stakeholders and subordinates.
• Spearheaded initiative to train regulatory affairs team, enhancing team knowledge and productivity.
• Assistance in developing SOPs to ensure Quality and Regulatory compliance.
• Assistance in internal and external Audits and Inspections.

• Development of regulatory strategies for oncology drugs, drug-device combinations, anti-infectives, additives to parenteral nutrition, leading to successful FDA / EU approval.
• Liasioning with regulatory agencies to negotiate and define the scope of regulatory submissions, ensuring compliance with local and international standards.
• Execution of due diligence assessments, identifying regulatory risks and opportunities that influenced business decisions.
• Contribution to the development of a proprietary regulatory intelligence database, streamlining data retrieval and analysis efforts for the whole department.
• Monitoring and assessment of the impact of regulatory changes and trends on the company's products and operations.
• Review of regulatory documents such as (A) NDAs, MAAs.

• Managed a team of 5 regulatory affairs specialists and oversaw the preparation and submission of regulatory documents for multiple products in various therapeutic areas.
• Handled the submission and maintenance of regulatory filings for a portfolio of over 10 pharmaceutical products, securing prolonged market presence and compliance in EU, US, PhMs
• Managed the documentary requirements for tender participation.
• Ensured compliance with global and regional regulatory requirements and standards.
• Orchestrated the creation and delivery of training programs for global regulatory requirements, equipping the team with the knowledge to tackle diverse international markets.
• Provided expert guidance on the regulatory landscape to influence product development and lifecycle management from a regulatory perspective.
• Participated in internal and external audits and inspections.
• Streamlined workflows by identifying bottlenecks in existing systems and implementing appropriate solutions.

• Served as the single point of contact between Regulatory affairs India team and counterparts at a global level.
• Supervised day-to-day operations to meet performance, quality and service expectations.
• Regulatory evaluation of change controls, technology transfer documents, DMF and outsource technical data package
• Assisted with the review of labeling and promotional materials for compliance with applicable regulatory requirements.
• Played a key role in the cross-departmental task force that addressed compliance issues, significantly reducing potential regulatory infractions.

• Routine and stability analysis on the IR/NDDS formulation, using various instruments and methods, and preparing STPs and SOPs as per cGMP standards.
• Documentation of all activities in notebooks and logbooks, maintained lab equipment, and calibration according to established procedures, ensuring all lab practices are following SOPs and GMPs.
• Collaborated with multidisciplinary teams to drive project success and achieve objectives.