Average salary: Rs250,000 /yearly
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Hi Greetings from Randstad we are hiring for Regulatory affairs specialist - IDMP Responsibilities : Lead/manage XEVMPD/IDMP submissions creation maintenance and their QC and
Compliance and All other XEVMPD/IDMP related activities.
- Responsible for tracking and communicating...
...authorities deficiency
Scientific Advice
Variations and Supplements (Type IA, IA, Type IB Type
Timely review of technical and regulatory documents i.e. Specifications, batch records, method validation documents, Stability data, container closure system, DMF review....
...:
- Accountable for the development and implementation of regulatory strategies in the International Markets (IM) region.
- Lead,... ...regulatory perspective
- Manage and review the work of IM regulatory affairs staff.
- Mentor and develop staff to ensure implementation of...
...Position : Executive Department : Regulatory Affairs - Formulation
Location : Kandivali - West, Mumbai
Qualification - M Sc/ B Pharm/ M Pharm
Experience : 4 - 8 years and above
Role
Responsible for activities related to own submission and support...
...About the role:
Reporting to the Head of Regulatory Affairs you will be a key member of the team which is responsible for providing strategic and operational regulatory support to project management on new divestment projects technical transfer CMOs quality assurance and...
Rs 2.4 - 4.2 lakhs p.a.
...work frequently with other employees and team members to coordinate complex activities, often with competing priorities.
Most regulatory affairs positions are full time.
Regulatory Responsibility means a duty or responsibility, assigned to an individual by...
...Lead consultant, Regulatory Affairs Pharmaceutical - LIF016236
With a startup spirit and 115,000 + curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it! We dream in digital, dare in reality, and reinvent the...
...members and provide CTA filing strategy and guidance on local regulatory requirements
- Review and approve CTA submissions in IM
-... ...scientific field
- At least 5 years of experience in regulatory affairs for pharmaceuticals/biologics (or equivalent combination of regulatory...
...related field
Prior experience in a quality assurance role preferably in a food testing lab.
Overall Accreditation Management Regulatory NABL FSSAI Apeda and BIS.
Implementation and monitoring of quality system as per ISO IEC 17025 and EMS and OHSMS
Internal Quality...
Job responsibilities:
Responsible for analyzing and qualifying an organization's product to ensure it meets quality and manufacturing standards.
Typically work with other engineering teams to identify potential errors in the process or standard and design improvements...
...Grade:
(if applicable)
(Functional)
Number of Direct Reports:
Directorship / Registration:
NA
Position Purpose
The Regulatory Reporting team is ramping up to about 20 members to address the ambitious project of standardizing the activity for APAC region. This...
Rs 7 - 11 lakhs p.a.
...Description : Design, build and configure applications to meet business process and application requirements. Must have Skills : SAP EHS Regulatory Compliance Good to Have Skills : No Technology Specialization Job Requirements : Key Responsibilities : a Candidate should be able...
...Manager Tech Risk& Regulatory Compliance
Experience: 710 years
Location: Mumbai
MustHave :
Technical Risk
Regulatory Compliance
IT Risk assessment
Presentation Skills
Report Writing Skills
Stakeholder Management
Job Description:
Technical:...
Job Description : This position will play a primary role in planning, implementing, and executing all aspects of Quality and Testing. The role requires hands-on QA expertise, ability to take initiative and develop and evolve our QA processes. TS2 knowledge and expertise is preferred...
Rs 5.5 lakh p.a.
...latest technologies and trends.
Develop, modify and implement component classification based on product contact / criticality with Regulatory and QA's help and define validation activity needed for each category of components.
Development and qualification of a wide...
Rs 2.2 - 2.8 lakhs p.a.
...checking and follow-up
Re-registration Dossier
Registration / Submission certificates updation
Translation files record
Regulatory Affair,Formulation,Pharmaceutical
Designation: Executive - Regulatory Affairs
Vacancies: 1
Experience: 1.0 Year(s) - 2.0 Year(s...
...perform Know-your-client (“KYC”) reviews on all new clients they adopt. These checks and reviews are made in strict accordance with regulatory requirement and the bank’s internal policies.
The project involves verification of the Client data, performing due diligence checks...
...difference with.
The opportunity
To organize and perform required regulatory tasks in order to maintain existing EU procedures in line with... ...duties and ad-hoc needs at the direction of Senior Regulatory Affairs personnel.
Awareness of current/pending regulatory...
...Topline:
Documentation of Regulatory product Dossiers, Compliance implementation within different verticals with Process and training
Regulatory Auditing skills for the compliance process strengthening
Legislative aspect of Regulations forming and designing
Advocacy...
...Essential
• Ph.D. in relevant discipline from reputed institution.
• First Class B.Pharm with Masters degree in Pharmaceutical Regulatory Affairs / Pharmaceutics.
• Registration as a pharmacist under the Pharmacy Act, 1948, as amended from time to time, including any...
SVKM's Narsee Monjee Institute of Management Studies (NMIMS)
Mumbai
1 day ago
