Regulatory Affairs
1 day ago
ear Candidate,
We are seeking a Senior Executive/ Assistant - Regulatory affairs Europe) to join our team, He/ she will be responsible for Dossier compilation, preparation, Life cycle management, Pre approval, Post approvals. based at Govandi Location.
Markets : Europe
Dosage Form : OSD/ Sterile
Key Responsibilities:
● Collate/prepare and file dossiers in a timely and accurate manner for formulations/ drug products to get licenses from various targeted markets.
● Prepare the checklist for documentation for regulatory filings as per current regulatory requirements (country specific).
● Collate and conduct first-level review/overview of relevant standard technical documentation like stability, TTD, PDR, method validations etc. as per the country requirements.
● Conduct initial review of the specifications of the API / Semi-Finished Product / Finished Product as per the regulatory requirements.
● Conduct initial review of labelling/artwork as per the market where the dossier is being filed
● Review and regulatory impact analysis of the change control, communication with customer for notification and approval as applicable.
● Review and regulatory impact analysis of the changes notified by the vendors as per current regulatory requirements (country specific), as desired.
● Evaluate any changes proposed post-approval. Prepare and file necessary amendments / supplements / annual reports as applicable to ensure regulatory compliance (Post-approval Life Cycle Management).
● e-CTD compilation/ publishing of DMF / Dossiers and Submission to customer / Health Authorities.
● Assist in resolution of queries received from customer/agency/regulator and assessing them before sharing with team leader.
● Preparation of Approval Package and sharing them with the respective manufacturing sites.
● Prepare and e-file documents for registration of any facility used (in process for drug) with Europe
Proficiencies and Expertise
● M. Pharma
● Proven experience in Regulatory affairs with 6-12 year of handling OSD/ Sterile Dosage form for Europe market would be preferred
-
Regulatory Affairs
1 day ago
Maharashtra, India, Govandi USV Full time ₹ 5,00,000 - ₹ 15,00,000 per yearJob Responsibility Collate/prepare and file dossiers in a timely and accurate manner for Formulations and API products to get licenses from various targeted markets.Review and regulatory impact analysis of the change control, communication with customer for notification and approval as applicable.Review and regulatory impact analysis of the changes notified...
-
Regulatory Affairs Executive
1 day ago
Mumbai, Maharashtra, India R. Wadiwala Sec Pvt Ltd Full timeDesignation : Regulatory Affairs Specialist - Qualifications : Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry - Experience : Minimum 2-5 years of experience in regulatory affairs - Salary : Good Hike on Current CTC - Location : Sandhurst Road Mumbai - Head
-
Regulatory Affairs Specialist
4 days ago
India Concept Medical Full timeAbout Us: Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in...
-
Regulatory Affairs Executive
5 days ago
Deccan Gymkhana, Pune, Maharashtra, India Zetta Women Full time**Job Title**:Pharmaceutical Regulatory Affairs Executive **(Intern)** **Location**: Pune, India **Duration**: 9 months (Advanced Certification) + 3 months (On the Job Internship) **Job Summary**: **Key Responsibilities**: 1. Attend classes on weekends (Saturdays and Sundays) 2. Complete coursework, assignments, and projects 3. Participate in...
-
Regulatory Affairs Officer
5 days ago
Manjri, Pune, Maharashtra, India Fusion Market Research Full time_**Duties/Responsibilities**:_ - Works in the regulatory affairs department on assigned projects. - Coordinates with product development and/or research and development teams to request, develop, and prepare required data and reports to be submitted to regulatory bodies and agencies. - Collaborates with key staff from Planning, Product Development,...
-
Regulatory Affairs Specialist
4 weeks ago
Mumbai, India OrbiTouch HR (orbiTouch outsourcing pvt ltd) Full timeJob Description Designation : Regulatory Affairs Specialist Qualifications: Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry Experience : Minimum 4 years of experience in regulatory affairs Salary : good hike on current salary Location : Sandhurst Road Mumbai - Head office Essential Duties and Responsibilities: -...
-
Regulatory Affairs Executive
7 days ago
Masjid, Mumbai, Maharashtra, India Amico Formulations LLP Full time**Post**: RA Executive **Experience**: 5+ Years Experience in Regulatory Affairs in Pharma Industry (Formulation) **Location**: Masjid Bunder, Mumbai - Experience in handling regulatory affairs for ROW market mainly Central and Latin American, African & Asian countries for Pharma Formulations. - Preparation, Compilation & Review of Registration documents...
-
Regulatory Affairs Executive(Female)
5 days ago
Mumbai, Maharashtra, India Double HR Consultancy Full timeVACANCY REGULATORY AFFAIRS EXECUTIVE (Pharma Company is manufacturing veterinary products) Job Location: Mumbai Maharashtra Eligibility: - M. Sc / B. Sc / M. Pharm / B. Pharm. Degree / Diploma in Regulatory Affairs. - Should have good knowledge of preparing registration of Drugs & Feed Supplements in different countries - Minimum 2 years experience in...
-
Drug Regulatory Affairs
3 days ago
Pimpri-Chinchwad, Maharashtra, India Statistical Pharma Full time**Regulatory Affairs Specialist duties and responsibilities** - Ensuring compliance with all regulatory requirements - Maintaining regulatory documentation database - Assisting with the preparation and submission of all regulatory reports - Providing accurate reviews of data and reports - Ensuring accurate and timely submissions to regulatory agencies -...
-
Regulatory Affairs Associate
3 days ago
Goregaon, Mumbai, Maharashtra, India Zivira Labs Private Limited Full time_**Regulatory Affairs Associate**_ As regulatory affairs associate you'll be the crucial link between the company, its products and regulatory authorities. You'll combine your knowledge of scientific, legal and business issues to ensure products, which are developed or manufactured, meet the required legislation. **Products include**: - Pharmaceuticals -...