![Statistical Pharma](https://media.trabajo.org/img/noimg.jpg)
Regulatory Affairs Executive
1 month ago
**Main Duties and Responsibilities**
- Work closely with the supplier/manufacturer and regulatory authorities/bodies regarding product submissions and compliance.
- Prepare product technical dossiers for regulatory submission for both new products and existing product’s variation.
- Liaise with relevant parties to resolve product registration and regulatory issues.
- Ensure all required procedures and documentation for product variation/new product registration are promptly performed.
- Notify and update Health Science Authority (HSA) of any change of particulars/documents related to product registration on a timely manner.
- Maintain document control of technical file, quality procedures and work instructions for the purpose of product registration and to support audits.
- Keep track of changes in country’s regulatory requirements and provide regulatory intelligence to management and Business Development and Sales team.
- Support in the maintenance of the Quality Management System to comply with GMP/GDP requirements and international regulatory requirements.
- Maintenance of HAS importer license, wholesale license and other licenses for business operation.
- Oversee Pharmacovigilance - reporting of adverse reaction, adverse event and post marketing related activities to product owner and regulatory authorities.
- Any other ad-hoc duties as and when assigned by immediate Reporting Officer
**Job Types**: Full-time, Permanent, Fresher
**Salary**: ₹25,000.00 - ₹60,000.00 per month
**Benefits**:
- Health insurance
- Provident Fund
- Work from home
Schedule:
- Day shift
- Morning shift
- Rotational shift
Supplemental pay types:
- Performance bonus
- Yearly bonus
Work Location: In person
-
Regulatory Affairs
7 days ago
Pune, India Statistical Pharma Full timeThe **Regulatory Affairs Specialist** stays with the same company for an average of 10 to 15 years; the rate of turnaround is therefore low. Networking is very much encouraged, through joining various associations to participate in conferences and exhibitions, and also to access current literature. Presently, there is a strong demand for Regulatory Affairs...
-
Regulatory Affairs Executive
5 days ago
Pune, Maharashtra, India Nissar Transformers Pvt Ltd Full timePosition - Regulatory Affairs (RA) Executive Location - pirangut Experience - 1 to 3 yrs **Responsibilities**: Strategy & Planning: Develop regulatory strategies for product approvals. Guide project teams on regulatory needs. Submissions: Prepare and submit regulatory documents (e.g., INDs, NDAs). Ensure timely and accurate...
-
Regulatory Affairs Executive
1 month ago
pune, India Randstad India Full timeDear Candidates Greetings from Randstad India ! We have an openingfor the role of Executive Regulatory Affairs with a leading pharmacompany in India. Interested candidates can drop your resume to the mailid The details arebelow: Qualification: B.Pharm / M. PharmExperience: 48 years Market:Canada Location: Pune Review of compilation...
-
Regulatory Affairs Executive
1 week ago
Pune, India Randstad India Full timeDear Candidates Greetings from Randstad India ! We have an openingfor the role of Executive Regulatory Affairs with a leading pharmacompany in India. Interested candidates can drop your resume to the mailid The details arebelow: Qualification: B.Pharm / M. PharmExperience: 48 years Market:Canada Location: Pune Review of compilation...
-
Drug Regulatory Affairs
1 month ago
Pune, 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 Officer
2 months 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
2 months ago
Pune, India Statistical Pharma Full timeThe 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...
-
Regulatory Affairs Executive
4 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 Executive
2 months ago
Pune, Maharashtra, India Statistical Pharma Full timeThe 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...
-
Gm-cluster Regulatory Affairs
1 week 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...
-
Director, Global Regulatory Affairs, Vaccines
3 weeks ago
pune, India 9627 Corixa Corporation Full timeAre you looking for a regulatory leadership role where you can build advocacy and accelerate product development and licensure on a global scale, but with a focus on US? If so, this Director, Global Regulatory Affairs, Vaccines role could be an exciting opportunity to explore. As a Director, Regulatory Affairs, Vaccines you will ensure the development and...
-
Director, Global Regulatory Affairs, Vaccines
3 weeks ago
Pune, India 9627 Corixa Corporation Full timeAre you looking for a regulatory leadership role where you can build advocacy and accelerate product development and licensure on a global scale, but with a focus on US? If so, this Director, Global Regulatory Affairs, Vaccines role could be an exciting opportunity to explore. As a Director, Regulatory Affairs, Vaccines you will ensure the development and...
-
Director, Global Regulatory Affairs, Vaccines
2 weeks ago
pune, India 9627 Corixa Corporation Full timeAre you looking for a regulatory leadership role where you can build advocacy and accelerate product development and licensure on a global scale, but with a focus on US? If so, this Director, Global Regulatory Affairs, Vaccines role could be an exciting opportunity to explore. As a Director, Regulatory Affairs, Vaccines you will ensure the development and...
-
Director, Global Regulatory Affairs, Vaccines
2 weeks ago
Pune, India 9627 Corixa Corporation Full timeAre you looking for a regulatory leadership role where you can build advocacy and accelerate product development and licensure on a global scale, but with a focus on US? If so, this Director, Global Regulatory Affairs, Vaccines role could be an exciting opportunity to explore. As a Director, Regulatory Affairs, Vaccines you will ensure the development and...
-
pune, India 9627 Corixa Corporation Full timeAre you looking for a regulatory leadership role where you can build advocacy and accelerate product development and licensure on a global scale, but with a focus on US? If so, this Director, Global Regulatory Affairs, Vaccines role could be an exciting opportunity to explore. As a Director, Regulatory Affairs, Vaccines you will ensure the development and...
-
Pune, India 9627 Corixa Corporation Full timeAt GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong...
-
pune, India 9627 Corixa Corporation Full timeAt GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong...
-
Pune, India 9627 Corixa Corporation Full timeAt GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong...
-
Global Regulatory Affairs Director
2 days ago
pune, India 9627 Corixa Corporation Full timeAt GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong...