Regulatory Affairs Associate
Regulatory Affairs Associate
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Job Description
Job summary
We are looking for an individual to carry out core regulatory activities including dossier finalization filing regulatory applications internal liaison for regulatory information compilation coordination with Quality Assurance teams during audits and ensuring regulatory compliance and systems.
Roles & Responsibilities
You will be responsible for the finalization of dossiers including drafting compilation archival and following systems and SOPs (Standard Operating Procedure) related to dossier management.
You will execute the filing of study applications (toxicity studies clinical studies marketing authorizations) manage administrative requirements for filing handle query responses process specific permissions at the Ministry of Science and Technology and the Ministry of Health such as licenses of import/export test commercial or permits.
You will be an internal liaison for compilation of regulatory information for dossiers and query responses working closely with CMC (Chemistry Manufacturing and Controls) NC (NonClinical) and clinical SMEs (Subject Matter Experts) to collect and transact information necessary for compilation.
You will be responsible for coordinating with Quality Assurance teams during audits actively participating in audits to transact regulatory information that supports facility inspections.
Your responsibilities include executing IBSC (Institutional Biosafety Committee) activities and reporting compliance to the Ministry of Science and Technology and drafting and implementing SOPs for key regulatory processes.
You will be responsible for drafting and compiling regulatory compliance correspondences as per country regulations particularly related to CMC (APQRs Annual Product Quality Reviews PACs Post Approval Changes) & Clinical (Phase 4 PSURs Periodic Safety Update Reports PILs Patient Information Leaflets IBs Investigators Brochures compensation reports etc.).
You will be involved in designing customizing and maintaining regulatory information systems such as SharePoint Electronic Common Technical Document (eCTD) and Document Management System (DMS).
Qualifications :
Educational qualification: A Masters degree in any of the life sciences (Microbiology Biochemistry Biotechnology Bioinformatics Immunology regulatory affairs pharmacy etc.); Bachelors will be considered if there is sufficient prior experience
Minimum work experience: 2 years of experience in regulatory affairs; total 6 years biologics/biosimilar research and development is good to have
Skills & attributes:
Technical Skills
Ability to stay uptodate with business priorities and a skill to calibrate strategies against the changing dynamics of the business environment.
Good understanding of Information Technology (IT) platforms supporting regulatory activities including eCTD DMS and Regulatory Information Management System (RIMS).
Knack for analysing regulatory information to identify risks demonstrating the ability to assess regulatory data critically and identify potential challenges or areas of concern.
Behavioural skills
Possesses strong negotiation skills cultural sensitivity and excellent interpersonal skills.
Pays meticulous attention to details in tasks and responsibilities.
Effectively manages and responds to ad hoc priorities that arise due to requests from the Ministry of Health (MOH).
Demonstrates a commitment to continuous learning and staying updated on the latest regulatory expectations.
Additional Information :
About the Department
Biologics
Currently operates in the Global Biosimilars business a segment that is poised for attractive and sustained growth over the next 1015year time horizon.
With a robust portfolio of biosimilar products across key therapeutic areas covering US$80 Bn in innovator sales future business pipeline covers a variety of product classes and therapy areas and new modalities. Fully integrated organization with over two decades of experience in developing manufacturing and commercializing multiple biosimilar products.
With a Product Development engine that has endtoend capabilities inhouse clone development upstream and downstream process development bioanalytical development and proprietary formulation.
Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs.
We have a proven experience in commercialscale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure
Rich experience of commercializing highquality biosimilars in multiple markets with over 900000 patients having benefited from our products till date.
Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys are on par with the best industry standards. They include among other things and other essential equipment joining & relocation support family support (Maternity & Paternity benefits) learning and development opportunities medical coverage for yourself and your family life coverage for yourself.
Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.
For more details please visit our career website at !/
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
