Executive - Regulatory Affairs at Umedica Laboratories PVT LTD

 

 

 

Umedica Laboratories Ltd. is part of a Amoli Group of Companies, manufacturing and exporting a wide range of Injectables, tablets, capsules, suspensions, dry syrups in the categories of non-steriodal anti-inflammatory (NSAIDs), antibiotics, antifungal, analgesics, antiviral, antituberculosis agents, antihistamines, psychotropics and multivitamins etc. Umedica's manufacturing facilities, located in Vapi, Gujarat, are comparable with the best in the world, and is supported by full-fledged Research & Deveploment center for developing new formulation and improving existing formulations. Umedica is a government recognized Export House, with exports to over 35 countries, and has won the 'Chemexcil Top Export Award' for performance in exports.

Job Title :

Executive - Regulatory Affairs

Job Description :

• Exposure of Regulatory Affairs for ASEAN or LATAM country will suffice.
• Basic exposure in Formulation Development / QA is preferable 

Eligibility                                 : B.sc / M.sc in Biochemistry / Life Science
Experience Required               : 3-5 years
Salary                                       : Not Disclosed by Recruiter
Industry                                    : Pharma / Biotech / Clinical Research
Functional Area                       : Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category                          : Bio/Pharma Informatics-Associate/Scientist
Role                                          : Bio/Pharma Informatics-Associate/Scientist
Key skills                                 : Regulatory Affairs, Qa , Formulation Development
Education                                 : UG -B.Sc - Any Specialization, Bio-Chemistry
                                                   PG - M.Sc - Any Specialization, Bio-Chemistry
                                                   Doctorate - Doctorate Not Required


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Opening for Senior Executive - Regulatory Affairs - Delhi

Job ID: 2749871511

Senior Executive - Regulatory Affairs - Delhi

Who we are

At Roche, 85,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche Diagnostics India, with a sales turnover of INR 150 crores, nurtures an open, flexible and challenging work environment, which allows for rapid career progression. Favored by its geographic location in the heart of Europe, the Basel area is one of the most dynamic economic regions in Switzerland — a great place to live and work.

The Position

 

Roles and Responsibilities

1. Preparation of regulatory documents e/g. DI, DII, DMF, PE Dossier, RTQ etc., with compilation of dossier, review regulatory application & submission of all required application pertain to Roche Diagnostics with full responsibility, accountability.

2. Understanding & interpretation of Law & the Local regulatory requirement and implementing same in India submission with compliance for Roche Products.

3. Responsibility for close coordination & regular follow-up with the Regulatory Authority for timely obtaining of all approvals.

4. Coordination with global regulatory team, local BA & other functions, required for regulatory submissions at India FDA.

5. Close monitoring of any changes in local & global regulation's and communicating same within the department.

6. Responsible for regulatory activity with compliance and maintain reputation of the organization before authorities.

7. Respecting & following all SOP / system implemented within the department and organization.

Who you are

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

Qualification - Graduate / Post Graduate in Bio-Chem / Molecular Biology / Microbiology with Minimum - 4-5 years of experience in handling regulatory documentation

Preferred - Post Graduate - with 5 yrs. experience

The next step is yours. To apply today, click on the "Apply online" button below.

Roche is an Equal Opportunity Employer

Apply online