Srinivas Parimi
Blacktown,Australia
Summary
Senior Regulatory Affairs Manager with extensive experience at Pharmacare Laboratories, specializing in regulatory strategy and submissions. Achieved a 20% reduction in approval timelines through effective cross-functional collaboration and mentoring. Expertise in regulatory documentation and health authority engagement, ensuring compliance and enhancing team performance.
Overview
14
14
years of professional experience
Work History
Senior Regulatory Affairs Manager – Rest of Asia Pacific (ROAP)
Pharmacare Laboratories Pty Ltd
Sydney, Australia
08.2023 - Current
- Led global and regional regulatory submissions (TGA, HSA, FDA-equivalent) across prescription medicines, complementary products, and cosmetic products.
- Developed regulatory strategies from early development through post-market lifecycle phases to support product registration and maintenance.
- Authored and reviewed regulatory documentation, including Product Information, CMIs, CTD dossiers, and technical summaries.
- Managed agency interactions, addressing regulatory queries, and deficiency letters efficiently.
- Collaborated with R&D, QA, and commercial teams to align clinical and regulatory strategies with business goals.
- Implemented regulatory change management processes and risk-based updates to ensure compliance.
- Mentored and coached regulatory staff, strengthening global regulatory capability.
- Successfully delivered multiple market registrations across Southeast Asia, reducing approval timelines by 20%.
- Recognized for regulatory leadership and strategy alignment across global teams.
- Developed and led regional training on pharmacovigilance and regulatory compliance.
- Developed regulatory strategies for product submissions and approvals.
- Managed compliance with local and international regulations and guidelines.
Regulatory Affairs Manager – ROAP
Pharmacare Laboratories Pty Ltd
Sydney, Australia
05.2019 - 08.2023
- Developed regulatory strategies for product submissions to health authorities.
- Successfully delivered multiple market registrations in Southeast Asia, reducing approval timelines by 20%.
- Managed relationships with external regulatory agencies to facilitate product approvals.
- Authored and reviewed comprehensive regulatory documentation, including Product Information and CTD dossiers.
- Monitored regulatory changes and communicated updates to relevant departments effectively.
- Collaborated with R&D, QA, and commercial teams to align regulatory strategies with business objectives.
- Implemented change management processes to enhance compliance with evolving regulations.
- Mentored regulatory staff, improving global regulatory capabilities across teams.
Senior Regulatory Affairs Associate – ROAP
Pharmacare Laboratories Pty Ltd
Sydney, Australia
06.2018 - 04.2019
- Led global and regional regulatory submissions (TGA, HSA, FDA-equivalent) across prescription medicines, complementary, and cosmetic products.
- Developed regulatory strategies from early development through post-market lifecycle phases to support product registration and maintenance.
- Authored and reviewed regulatory documentation including Product Information, CMIs, CTD dossiers, and technical summaries.
- Managed agency interactions, addressing regulatory queries and deficiency letters efficiently.
- Collaborated with R&D, QA, and commercial teams to align clinical and regulatory strategies with business goals.
- Implemented regulatory change management processes and risk-based updates to ensure compliance.
- Mentored and coached regulatory staff, strengthening global regulatory capability.
- Successfully delivered multiple market registrations across Southeast Asia, reducing approval timelines by 20%.
- Recognised for regulatory leadership and strategy alignment across global teams.
- Developed and led regional training on pharmacovigilance and regulatory compliance.
QA/RA Officer
Ixom Operations Pty Ltd
Sydney, Australia
01.2017 - 10.2017
- Supported GMP and ISO audit readiness and prepared technical documentation for raw materials supplied nationwide.
- Managed CAPA and deviation responses ensuring timely closeout and regulatory compliance.
- Supported clients to their regulatory and quality related documentation queries.
- Performed batch releases for products received from various suppliers.
Clearance Applications Assessor
Therapeutic Goods Administration
02.2016 - 04.2016
- Evaluated GMP clearance submissions and manufacturing site compliance under the MRA framework.
- Prepared technical assessment reports recommending certification outcomes.
QA Associate
Hospira (Pfizer Company)
03.2012 - 01.2013
- Supported quality operations, batch record reviews, and CAPA management under cGMP conditions.
Education
Certificate in Australian Regulatory Affairs -
ARCS
01.2022
PhD - Nanotechnology
University of South Australia
MSc - Biotechnology
Griffith University
BSc - Biochemistry,Biotechnology,Zoology
Andhra University
Skills
- Regulatory strategy and scientific advice
- Regulatory submissions
- Lifecycle management and labeling oversight
- Regulatory intelligence and risk assessment
- Cross-functional collaboration
- Regulatory documentation
- Health authority engagement and negotiation
- Process improvement and mentoring of team members on various projects
Accomplishments
- Developed strategic regulatory pathways to accelerate submissions and reduce time to market.
- Drove process improvement initiatives resulting in enhanced compliance and documentation quality.
- Recognized for delivering innovative and scientifically grounded regulatory solutions.
Timeline
Senior Regulatory Affairs Manager – Rest of Asia Pacific (ROAP)
Pharmacare Laboratories Pty Ltd
08.2023 - Current
Regulatory Affairs Manager – ROAP
Pharmacare Laboratories Pty Ltd
05.2019 - 08.2023
Senior Regulatory Affairs Associate – ROAP
Pharmacare Laboratories Pty Ltd
06.2018 - 04.2019
QA/RA Officer
Ixom Operations Pty Ltd
01.2017 - 10.2017
Clearance Applications Assessor
Therapeutic Goods Administration
02.2016 - 04.2016
QA Associate
Hospira (Pfizer Company)
03.2012 - 01.2013
Certificate in Australian Regulatory Affairs -
ARCS
PhD - Nanotechnology
University of South Australia
MSc - Biotechnology
Griffith University
BSc - Biochemistry,Biotechnology,Zoology
Andhra University