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Job Description

Medicinal products, pharmaceuticals, veterinary medicines, medical devices, and food supplements – all these products are subject to regulations designed by governments to protect public health. The Regulatory Affairs departments of life-science companies ensure that their companies comply with all of the regulations and laws concerning their business.

The Regulatory Affairs department is an important part of the organisational structure of pharmaceutical companies. Internally it liaises at the interphase of drug development, manufacturing, marketing and clinical research. Externally it is the key interface between the company and the regulatory authorities.

Regulatory Affairs is involved in the development of new medicinal products from early on, by integrating regulatory principles and by preparing and submitting the relevant regulatory dossiers to health authorities. Regulatory Affairs is actively involved in every stage of development of a new medicine and in the post-marketing activities with authorised medicinal products.

Regulatory Affairs contributes essentially to the overall success of drug development, both at early pre-marketing stages and at all times post-marketing. The pharmaceutical industry deals with an increasing number of interesting drug candidates, all of which necessitate the involvement of the Regulatory Affairs’ department. Regulatory Affairs professionals can play a key role in guiding drug development strategy in an increasingly global environment. But they also play an important operational role, for example, by considering the best processes to follow and enabling structured interaction with regulatory authorities. Regulatory Affairs is driven by good science and accordingly nothing remains static.

Regulatory affairs professionals are involved in product development from the beginning. Regulatory restraints and requirements need to be considered when drafting the pharmaceutical, preclinical and clinical development plan. Development targ

Key Skills

Industry

Pharma/BioTech/Clinical Research

Functional Area

Pharma / R&D / Biotech

Number of Vacancy

3

Education

B.Pharma, B.Sc, M.Pharma, M.Sc


About Purvanchal Business Solution

1. To establish the quality system
a. Establish the quality management system to describe how the firm complies
CGMPs and operates to maintain a state of control
b. Keep current with good industry practices, and applicable to the mission of your operation.
2. To audit compliance to the quality system
a. Audit for compliance to policies and procedures: on paper vs. practice
b. Report on the performance of the quality system, including trends, that help
decision making for targeted actions
3. To establish procedures and specifications
a. Ensure that procedures and specifications are appropriate and followed
b. Ensure that the procedures and specifications of firms under contract are also appropriate and followed, i.e., maintain control and take responsibility for third-party services providers (contract manufacturers, contract laboratories, etc.)
4. To establish manufacturing controls
a. Ensure that appropriate manufacturing in-process controls are implemented
b. Ensure in-process controls are performed during manufacturing operations and results are satisfactory
5. To perform laboratory tests or examinations
a. Perform laboratory testing of components, containers, in-process materials, packaging materials and drug product using validated methods against scientifically-derived, fit-for-purpose specifications
b. Approve or reject drug products manufactured, processed, packed, or held under contract by another company, i.e., final product release is not delegated to a contractor
c. Perform retests or reexamine approved components, drug product containers and closures after long storage or exposure to adverse conditions
6. To review and approve or reject all things CGMP
a. Review and approve/reject any document that gives work instructions and set requirements such as procedures, protocols, test methods, and specifications—including changes to these documents
b. Review and approve/reject reprocessing and rework proced

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