Welcome to therdose

R&D Partner

A Strategic R&D Partner for emerging global pharma corporates
Quality Systems

Build with high Quality systems that can suite the regulatory approvability.
Manufacturing

Sterile cGMP/WHO approved manufacturing unit for Oncology products.
Recognised Lab

Our in-house RnD unit is recognised by Department of Scientific and
Industrial research (DSIR), Government of India.
Working Model

A manufacturing partner for Oncology products.
Quality Systems

Build with high Quality systems that can suite the regulatory approvability

JOBS IN Pharma

Career Opportunities

We bring to the prospective talents myriad award-winning career opportunities under disciplined working culture fostered to help you cultivate competence, excellence, and brilliance in your forte. Join us for rewarding career experience where talent is nurtured.

Current Openings

RA
QA
Artwork (P&D)
Purchase/Warehouse
QC - Injectable
QC – Injectable/Solids
ADL -Injectables
Analytical
Solids-AD
AMV Lab
F R & D

Regulatory Affairs


Qualification	:	BPharm / MPharm	:
Experience	:	12+ Years
Job Description	:	Achieve timely submission of dossier deficiency responses to regulatory authority by reviewing, collating, and compiling documents in order to ensure approvals for launch in stipulated time Submit post approval variations for changes that improves productivity, cost-effectiveness, quality of the product by reviewing, collating, compiling the variation application to meet the delivery within timelines and maintain Product Marketing Authorization, Renewals to ensure continuous validity of marketing authorizations. Maintain, and update product dossier as required to meet changes in internal systems, changes in regulatory guidelines, and to meet the need of regulatory requirements. Update the database associated with product dossier approvals by including registration details in database. Provide Regulatory support throughout the life cycle of the product for smooth functioning. Check with regulatory authorities for submission activity and approval status for submission done. Coordination with internal and external stakeholders for regulatory filing related documentation. Review, compilation and authoring of as per regulatory requirements. Review of plant and R&D documentation such as development reports, BMR, BPR, Specifications, method validation, process validation etc. Consulting, categorizing, authoring Post approval changes through appropriate supplements. Provide responses to regulatory agencies regarding product information or issues. Train staff in regulatory policies or procedures. Develop and maintain standard operating procedures or local working practices. Establish regulatory priorities or budgets and allocate resources and workloads. Communicate regulatory information to multiple departments and ensure that information is interpreted correctly


		Apply Now

R&D Partner

Quality Systems

Manufacturing

Recognised Lab

Working Model

Quality Systems

Career Opportunities

Quality Assurance

Artwork (Packaging and Development)

Purchase/Warehouse

QC - Injectable

QC – Injectable/Solids

ADL -Injectables

Analytical

Regulatory Affairs

Solids-AD

AMV Lab

F R & D


No More Vacancies


No More Vacancies


No More Vacancies


No More Vacancies