Tejal Ashar
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Tejal Ashar Email & Phone Number

Regulatory Affairs Manager | Overseeing 30+ MEA Markets | 15+ Years of Regulatory Compliance Expertise | Product Lifecycle Management & Regulatory Strategy Development | Quality & Change Control at Juniper Biologics
Location: Dubai, United Arab Emirates, United Arab Emirates 6 work roles 2 schools
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Regulatory Affairs Manager | Overseeing 30+ MEA Markets | 15+ Years of Regulatory Compliance Expertise | Product Lifecycle Management & Regulatory Strategy Development | Quality & Change Control
Location
Dubai, United Arab Emirates, United Arab Emirates

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Tejal Ashar is listed as Regulatory Affairs Manager | Overseeing 30+ MEA Markets | 15+ Years of Regulatory Compliance Expertise | Product Lifecycle Management & Regulatory Strategy Development | Quality & Change Control at Juniper Biologics, based in Dubai, United Arab Emirates, United Arab Emirates. AeroLeads shows a matched LinkedIn profile for Tejal Ashar.

Tejal Ashar previously worked as Regulatory Affairs Manager – MEA at Juniper Biologics and Regulatory Affairs Manager – MEA – Rx Portfolio at Mundipharma. Tejal Ashar holds Pgdip, Industrial Management from Welingkar Institute Of Management.

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Juniper Biologics

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About Tejal Ashar

With over 15 years of experience in regulatory affairs across the Middle East and Africa (MEA), I bring a strategic approach to regulatory compliance, product lifecycle management, and stakeholder engagement. My expertise spans managing regulatory submissions, leading cross-functional teams, and executing global strategies for complex portfolios, with a proven track record of ensuring timely approvals and market access for a wide range of products i.a. specialty, oncology, respiratory, and ophthalmology.Key Career Achievements:🟡 Led regulatory affairs across 30 MEA countries for a broad Rx portfolio, including Specialty, Respiratory, Oncology, and Ophthalmology, collaborating with global teams (Switzerland, UK, Australia) at Mundipharma. Successfully registered a full specialty portfolio in all 30 markets, navigating diverse regulatory landscapes to ensure timely approvals.🟡 Received the Above and Beyond Award at NewBridge Pharmaceuticals for achieving the highest number of product approvals across MEA ahead of schedule, exceeding expectations for market entry.🟡 Developed and implemented regulatory strategies for new product registrations, lifecycle management, and market entry for Juniper Biologics, ensuring ongoing compliance across the GCC, Levant, and North African markets.Areas of Expertise:Regulatory Strategy Development & Implementation, Regulatory Compliance, Change Control Management, Regulatory Submissions, Team Leadership, Stakeholder Engagement, Product Lifecycle Management, Global Regulatory Affairs, Risk Assessment & Gap Analysis, Labelling & Packaging Compliance, Cross-Functional Team Collaboration, Portfolio Management, Project Management, Good Manufacturing Practices, GCC Compliance, PSUR, RTQ, Veeva RIM, Saudi Drug Registration SystemThroughout my career, I've been instrumental in aligning regulatory strategies with business objectives, working closely with commercial, medical, and marketing teams to optimize market access and secure successful product approvals. I have also built and nurtured strong relationships with external stakeholders, including Ministries of Health (MOH), regulatory authorities, and regional distributors. By fostering these partnerships, I ensure streamlined communication, regulatory alignment, and smooth product introductions into new markets, driving business success.Regulatory Affairs Manager | RA Manager | Senior Regulatory Affairs Manager | Senior Manager

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Juniper Biologics
Juniper Biologics
Regulatory Affairs Manager | Overseeing 30+ MEA Markets | 15+ Years of Regulatory Compliance Expertise | Product Lifecycle Management & Regulatory Strategy Development | Quality & Change Control
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6 roles · 21 years

Tejal Ashar work experience

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Regulatory Affairs Manager – Mea

Current

Dubai, United Arab Emirates

Managing regulatory affairs across MEA, including GCC, Levant, and North African markets. Responsible for new product registration, lifecycle maintenance, renewals, variations, RTQ submissions, safety label updates, and PSUR submissions. Ensure timely approvals and maintain regulatory databases to support compliance and product success.

Sep 2024 - Present

Regulatory Affairs Manager – Mea – Rx Portfolio

Dubai, United Arab Emirates

  • Led regulatory activities across 30 MEA countries for a broad Rx portfolio, including Specialty, Respiratory, Oncology, and Ophthalmology, reporting to the Regulatory Affairs Specialist MEA and mentoring 1 Regulatory.
  • Registered the full specialty portfolio in 30 markets.
  • Managed change control processes by assessing regulatory impacts and collaborating with internal teams (Business Development, Commercial, Marketing, and Medical) to devise regulatory strategies for product submissions.
  • Coordinated with the global team (Switzerland, Australia, UK) and partners (Switzerland, Ireland, Canada) to secure necessary documentation for new submissions and life cycle management while supporting local teams in.
  • Fostered strong relationships with external stakeholders, including MOH officials and regional distributors.
May 2014 - Jun 2024

Regulatory Affairs Manager – Mena

Dubai, United Arab Emirates

  • Managed Oncology product registrations across MENA, coordinating with US and UK partners for documentation and supply chain for samples. Oversaw lifecycle management and maintained product databases. Collaborated with.
  • Received the Above and Beyond Award for achieving the highest number of product approvals across MEA ahead of schedule.
Feb 2011 - Apr 2014

Regulatory Affairs / Technical Associate – Mena

Dubai, United Arab Emirates

  • Handled the preparation, submission, and approval for transferring the Marketing Authorization Holder from GSK to Aspen for MENA countries.
Aug 2009 - Sep 2010

Regulatory Affairs Associate & Change Control Co-Coordinator

Dubai, United Arab Emirates

  • Managed the Global Product Conformance (GPC) Project, ensuring the organization and submission of CMC documents in CTD format to the hub factories in the UK and USA, meeting strict deadlines for pharmaceutical products.
2008 - 2009 ~1 yr

Regulatory Affairs Officer

Dubai, United Arab Emirates

  • Prepared documentation for registering locally manufactured Global Pharma products in compliance with the UAE Ministry of Health and the Gulf Central Committee (GCC), as well as other Arab and African countries, before.
2005 - 2007 ~2 yrs
2 education records

Tejal Ashar education

FAQ

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What company does Tejal Ashar work for?

Tejal Ashar works for Juniper Biologics.

What is Tejal Ashar's role at Juniper Biologics?

Tejal Ashar is listed as Regulatory Affairs Manager | Overseeing 30+ MEA Markets | 15+ Years of Regulatory Compliance Expertise | Product Lifecycle Management & Regulatory Strategy Development | Quality & Change Control at Juniper Biologics.

Where is Tejal Ashar based?

Tejal Ashar is based in Dubai, United Arab Emirates, United Arab Emirates while working with Juniper Biologics.

What companies has Tejal Ashar worked for?

Tejal Ashar has worked for Juniper Biologics, Mundipharma, Newbridge Pharmaceuticals, Aspen Pharma Group, and Wyeth.

How can I contact Tejal Ashar?

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What schools did Tejal Ashar attend?

Tejal Ashar holds Pgdip, Industrial Management from Welingkar Institute Of Management.

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