Regulatory Affairs Specialist
- Dr Reddys
- 7 - 12 years
- 5 months ago
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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 (Non-Clinical), 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 (APQR's - Annual Product Quality Reviews, PAC's - Post Approval Changes) & Clinical (Phase 4, PSUR's - Periodic Safety Update Reports, PIL's - Patient Information Leaflets, IB's - Investigator's 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).
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 experienceMinimum work experience: 2 years of experience in regulatory affairs; Any additional experience in biologics/biosimilar research and development is good to haveSkills & attributes:Technical Skills
Ability to stay up-to-date 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.
About the Department
Biologics
Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 1015-year 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 end-to-end capabilities in-house 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 commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure
Rich experience of commercializing high-quality biosimilars in multiple markets with over 900,000 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 https://careers.drreddys.com/#!/
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Legal & RegulatoryRole Category: Corporate AffairsRole: Regulatory Affairs ComplianceEmployement Type: Full timeContact Details:
Company: Dr ReddysLocation(s): Pydibimavaram
Keyskills: ectd information management biologics regulatory dossier interpersonal skills sharepoint regulatory compliance dms research healthcare core system compilation compliance quality assurance negotiation rim biosimilars regulatory affairs cmc formulation pharmacy life sciences
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