- 8+ years' experience in handling life cycle management of approved drug products (like- tablets (oral solids), syrups (oral liquids), parenterals (injections/ injectables for EU market.
- Good understanding of regulatory framework, including regional trends, for various types of applications and procedures
- Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.
- Working knowledge of EU/US regulatory procedures including post approval requirements. Knowledge of ROW markets regulatory legislations would be an added advantage
- Experience in handling CMC related health authority queries
- Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries.
- Liaise closely with cross-functional members with aligned product responsibilities.
- Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
- To prepare, review and submit safety variations to Health Authorities and also perform post Approval CMC related updates (where applicable).
- Prior working experience in Regulatory Information Management Systems like Veeva Vault would be desirable.
- Strong communications skills
- Ability to work independently.
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Regulatory Affairs Consultant
1 week ago
Parexel Hyderabad, India Full timeWhen our values align, there's no limit to what we can achieve. · Regulatory Affairs Consultant. · 8+ years' experience in handling life cycle management of approved drug products (like- tablets (oral solids), syrups (oral liquids), parenterals (injections/ injectables for EU m ...
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Regulatory Affairs Consultant
5 days ago
Parexel hyderabad, IndiaWhen our values align, there's no limit to what we can achieve. · 8+ years' experience in handling life cycle management of approved drug products (like- tablets (oral solids), syrups (oral liquids), parenterals (injections/ injectables for EU market. · Good understanding of re ...
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Opening for Encase
2 weeks ago
Orcapod Hyderabad, IndiaE- dicovery solution With Implementation , · expns in cloud and end and endpoint experience. · secondary skills: encase tools: sanfsist · Role: · Head - Regulatory Affairs · - Salary: · 6,00, ,00,000 P.A. · - Industry: · IT Services & Consulting · - Functional Area: · Legal & Re ...
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Regulatory Affairs Associate
2 weeks ago
Parexel Hyderabad, IndiaHyderabad, India · **Job ID** R · **Category** Regulatory / Consulting · **ABOUT THIS ROLE**: · **Regulatory Affairs Associate** · Must have experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts. · - To provide regulatory input on procedural and CMC docume ...
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Company Secretary
2 weeks ago
Grid Dynamics Hyderabad, India**Job description** · We are looking for a motivated and organized individual to join our team as a Company Secretary. In this role, you will be responsible for ensuring that our Company comply with all legal and regulatory requirements on Companies Act matters. You will also be ...
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Video Producer
2 weeks ago
ShowTime Consulting Hyderabad, IndiaJob Description: Video Producer (Telugu Language) · Position Overview: · **Responsibilities**: · 1. Collaborate with the creative team to develop engaging video concepts and storylines that align with client objectives and target audience. · 2. Write compelling scripts in the Tel ...
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Stenographer
2 weeks ago
HungryBird Consulting Services Pvt Ltd Hyderabad, IndiaGreetings from **Hungry Bird IT Consulting Services Pvt Ltd ** · We're hiring for **Stenographer **for our client. · **Qualification**: Any graduate/PG · **Location**: Hyderabad · **Experience**: 1 to 3 years · **Roles and responsibilities**: · - Typing and taking dictation in sh ...
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General Studies Faculty
2 weeks ago
ACE Online Hyderabad, India**Position Summary**: · **Key Responsibilities**: · Course Delivery: Plan and deliver engaging lectures, presentations, and discussions on a variety of topics related to general studies. These topics may include but are not limited to social sciences, humanities, natural sciences ...
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Clinical Safety Contractor
2 weeks ago
NITZ Consulting Private limited Hyderabad, India Freelance**NITZ Consulting private Limited Inc. ("NItz") **is committed to providing quality service in the field of pharmacovigilance to clients. Our clients range from mid-size to small pharmaceutical companies located worldwide who are engaged in developing a proprietary pipeline of no ...
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Travel Associate
1 week ago
BCD Travel Corporate Hyderabad, India**Bring your passion and energy to our growing team. We're hiring** · **Travel Associate** · - Full Time, Hyderabad India_ · **_ _**As a **Travel Associate**, · You will will be the first person in the market and really a pioneer. · You must be highly resourceful, self-sustained ...
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Administrative Assistant
1 week ago
U.S. Embassy & Consulates in India Hyderabad, India**Hiring Path**: · - Open to the public · **Who May Apply/Clarification From the Agency**: · - For USEFMs grade is FP 07. Actual FP salary determined by Washington D.C.- All Interested Applicants / All Sources · **Security Clearance Required**: · Public Trust - Background Investi ...
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Stenographer
5 days ago
Hungry bird IT Consulting Services Pvt Ltd Hyderabad, IndiaGreetings from **Hungry Bird IT Consulting Services Pvt. Ltd** · We're hiring a **Stenographer **for our client. · **Qualification**: Any Graduate · **Location**: Hyderabad · **Experience**: 2 to 4 years of experience · **Work type**: Work from office · **Roles and Responsibiliti ...
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Global Clinical Publishing Associate
5 days ago
Novartis Hyderabad, Telangana, India**Summary**: · Ensure compliance with internal and external guidelines, to compile and add electronic navigation to clinical and regulatory documents. Support the timely submission of documents to the Health Authorities (HAs) and provide publishing consultancy to the clinical tea ...
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Hospital Administration
1 week ago
Vision Prime Services Pvt Ltd Attapur, Hyderabad, Telangana, IndiaJOB DESCRIPTION: · 1.Develop and implement effective policies for all operational procedures · 2. Prepare work schedules · 3. Maintain organized medical and employee records · 4. Monitor administrative staffs performance · 5. To look after all the affairs and activities of the ho ...
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Seven Consultancy hyderabad, IndiaJOB DETAILS · 1.Review all data and documents related to product registrations for various health authoritiesCompilation of Drug Master Files · 2.Registration Dossiers & Technical Data Packages/OpenParts · 3.In-House developed APIs manufactured at In-House API manufacturing si ...
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Senior Data Engineer
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Kamet Consulting Group Hyderabad, IndiaPosition: Senior Data Engineer / Power BI Developer · Location: Hyderabad or Bangalore (Other locations will be considered for the right candidate) · Job Description: · We are looking for a Senior Data Engineer / Power BI Developer with experience of developing end to end analyti ...
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Seven Consultancy hyderabad, IndiaJOB DETAILS · 1) Good knowledge and understanding of the working of the Indian Power Sector related to power distribution business, particularly regulatory affairs like preparation and filing of ARR, MYT, True - up petitions. · 2) Experience of preparation of Standard of Perfor ...
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Seven Consultancy hyderabad, IndiaJOB DETAILS · 1) Good knowledge and understanding of the working of the Indian Power Sector related to power distribution business, particularly regulatory affairs like preparation and filing of ARR, MYT, True - up petitions. · 2) Experience of preparation of Standard of Perfor ...
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Seven Consultancy hyderabad, IndiaJOB DETAILS · 1) Knowledge of GMP and QMS standards · 2) Knowledge of regulatory affairs procedures · 3) Knowledge of documentation · 4) To Check the in process inspection of semi finished and finished product · 5) To document all the reports. · 6) Maintain discipline in contro ...
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Seven Consultancy hyderabad, IndiaJOB DETAILS · 1) To look after all the affairs and activities of hospital except dealing with the consultant doctors. · 2) Proper filing / noting of the patients. · 3) Daily bill collection from the patients. · 4) overall incharge of the nursing / technicians / non technician s ...
Regulatory Affairs Consultant - Hyderabad, India - Parexel
Description
Regulatory Affairs Consultant.
Regulatory Affairs Consultant professionals in Hyderabad
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Sneha Kannan
Biotechnologist
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Parusha Ram Sagar
MSc in Chemistry | Fresher | QA,Qc, RA,
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MD SABEELKHAN PATEL
REGULATORY AFFAIR
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Balaramakrishna venugopal Namburi
Regulatory affairs Medical devices
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Satya Prashanth
Legal Counsel
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Anjala Pranathi
Clinical Research, Clinical Data Management, PV