- Responsible as toxicological expert for permitted daily exposure determination strategy documents.
- Responsible for providing pharmacology and regulatory support to obtain Marketing Authorisations.
- Assessment of toxicological data/literatures and review of scientific justifications.
- Non-clinical expert for regulatory submissions.
- Co-ordinating toxicological studies with CROs and providing toxicological guidance to all stakeholders.
- Provide input into all stages of the companys development and portfolio of products and to develop strategies to ensure a complete and rapid development.
- Review and approval of overviews and summaries. Manage the preparation of Regulatory documentation, focusing on clinical and non clinical.
- Management of regulatory submissions and procedures (e.g. for national or centralised scientific advice procedures, clinical/non clinical trial applications, marketing authorisation applications, post-authorisation procedures, waivers and/or deferrals).
- Identify Regulatory opportunities or issues and problems related to designated
- Licensing and due diligence’.
- Regulatory and pharmacology intelligence.
- Regulatory strategy and contributing to development programmes.
- Ensuring that all processes and data are kept in an inspection and audit ready condition at all times.
ESSENTIAL EXPERIENCE, SKILLS AND ABILITIES:
- More than 10 years of core Pharmacology (Toxicology) experience.
- Qualification: MBBS/MD/Mpharm (pharmacology).
- Clinical & non-clinical studies experience.
- Line management and team leadership experience.
- Excellent managerial skills.
- Experience with Specialty care and Paediatrics is advantageous.
Salary: INR 12,00,000 - 16,00,000 PA.
Role Category:Drug Regulatory Affairs/Documentation
Role:Regulatory Affairs Manager
Must have Key Skills
Other Key Skills
UG:MBBS - Medicine
PG:M.Pharma - Pharmacy
Doctorate:Ph.D - Medicine, Pharmacy
SYRI Research Pvt. Ltd.
SyriMed previously known as Thame Laboratories Licensed Medicines Division is one of the leading Pharmaceutical Companies in the UK specialising in the development, licensing, manufacture and marketing of liquid medicines.
Established during 2004 in Ruislip, West London; SyriMed with the experience from the development and manufacture of unlicensed medicines started in 2014 to obtain marketing authorisations for its unlicensed liquid medicines. In May 2020, SyriMed held over 50 marketing authorisations for liquid medicines within the UK.
SyriMeds success stems from its vibrant and productive Research and Development Department which develops and manufactures formulations for licensed medicines . All of SyriMeds formulations for which it holds marketing authorisations have been developed by SyriMeds own scientists.
SyriMed manufactures licensed medicines in its own facilities that meet the quality requirements of EU Good Manufacturing Practice (GMP).
Our in-house laboratories test the medicines manufactured to ensure they meet the strict requirements set by regulatory authorities.