Regulatory Affairs Executive
21 hours ago
The role and function of a Regulatory Affairs Officer includes the following duties and responsibilities:
- Preparing submissions of licence variations and renewals to strict deadlines;
- Ensuring that a company’s products comply with regulations;
- Keeping abreast of international legislation, guidelines and customer practices in all countries that the company is exporting to;
- Negotiating with regulatory authorities for marketing authorisation;
- Specifying storage, labelling and packaging requirements.
- Collecting, collating and evaluating scientific data that has been researched by colleagues;
- Developing and writing clear arguments and explanations for new product licences and licence renewals;
- Planning and developing product trials and interpreting trial data;
- Advising scientists and manufacturers on regulatory requirements;
- Reviewing company practices and providing advice on changes to systems;
- Liaising with, and making presentations to, regulatory authorities;
- Monitoring and setting timelines for licence variations and renewal approvals;
- Working with specialist computer software and resources;
- Writing clear, accessible product labels and patient information leaflets;
- Providing strategic advice to senior management throughout the development of a new product;
- Project managing teams of colleagues involved with the development of new products;
- Undertaking and managing regulatory inspections;
**Salary**: ₹25,000.00 - ₹65,000.00 per month
**Benefits**:
- Cell phone reimbursement
- Internet reimbursement
- Work from home
Schedule:
- Day shift
Supplemental pay types:
- Performance bonus
-
Regulatory Affairs Executive
21 hours 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 Analyst
2 weeks ago
Pune, Maharashtra, India Varex Imaging Corporation Full time ₹ 4,00,000 - ₹ 12,00,000 per yearTo apply to a Varex Imaging position, please create an account and sign-in.CURRENT VAREX IMAGING EMPLOYEES: Please apply by logging into your internal Workday Account.SummaryVarex Imaging Regulatory Affairs Analyst participates in the compliance of medical and industrial x-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional...
-
Regulatory Affairs Officer
20 hours 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 Executive
6 days ago
Balaji Nagar, Pune, Maharashtra, India Vertex Business Solutions Full timeRegulatory Affairs Executive act as a link between companies and regulatory authorities, ensuring that products are manufactured, tested and distributed in compliance with appropriate legislation. **Responsibilities**: - studying scientific and legal documents to check they meet legal requirements. - Gathering, evaluating, organising, managing and...
-
Regulatory Affairs Officer/ Executive
2 weeks ago
Pune, India Imaec Medntek Full timeOur highly skilled workforce, with their unwavering commitment to excellence, will be the critical pillar for IMAEC MEDNTEK's success story. We will achieve our shared goals and organizational objectives by strategically focusing on attracting, retaining and developing the correct talent mix with diversity in relation to gender, age, expertise and...
-
Regulatory Affairs Manager
2 weeks ago
Pune, Maharashtra, India Batavia Pharma Pvt Ltd Full timeRole & responsibilitiesRole Overview:The Regulatory Affairs Manager will be responsible for overseeing all regulatory aspects of projects, ensuring compliance with global guidelines, and leading regulatory submission. Responsible for preparing, reviewing, and compiling high-quality CMC (Chemistry, Manufacturing, and Controls) documentation for regulatory...
-
Manager Regulatory Affairs
1 week ago
Pune, Maharashtra, India Emcure Full time ₹ 6,00,000 - ₹ 18,00,000 per yearRole: Regulatory Affairs ManagerJob Location: PuneExp: 8-14 YearsQualification: B.Pharm/M.PharmJob Responsibilities:Dossier preparation, Submission, Compilation, Query Response, Variation fillingResponsible for pre and post approval activities.Handling Europe Market.Strong knowledge of EU regulatory frameworks and guidelines (e.g., EMA, ICH, eCTD).Experience...
-
Gm-cluster Regulatory Affairs
2 weeks ago
Pune, India Vodafone Idea Full timeJob Req ID: 39631- Location: Pune, IN- Function: Other- About: - Vodafone Idea Limited is an Aditya Birla Group and Vodafone Group partnership. It is India’s leading telecom service provider. The Company provides pan India Voice and Data services across 2G, 3G and 4G platform. With the large spectrum portfolio to support the growing demand for data and...
-
Regulatory Affairs Operations Specialist
5 days ago
Pune, India Respironics Inc Full timeJob Description Job Title Regulatory Affairs Operations Specialist Job Description Job Responsibilities: - International Registrations - Upload, Verify, and Validate the data with new Regulatory Information to the RIM database - Maintain Registration &Licensing Information - Create Submission Packages for International Registrations - Initiate Renewals with...
-
Pune, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...