HETERO Pharmaceutical Company, in Hyderabad, is looking for B Pharmacy / M Pharma (Regulatory Affairs) candidates for the Regulatory Affairs Department. Interested & eligible candidates apply now.
Both males & Female candidates are eligible to apply.
About the Company: A leading USFDA-approved Pharmaceutical Company, Engaged in the development, manufacturing, and marketing of high-quality chemical and biological drugs. Hetero Drugs Limited is an Indian-based pharmaceutical company that is one of the leading manufacturers of generic drugs in India. It was founded in 1993 and is headquartered in Hyderabad. The company specializes in the manufacturing and marketing a wide range of pharmaceutical products, including active pharmaceutical ingredients (APIs), finished dosages, and biopharmaceuticals. Hetero Drugs has a strong presence in the domestic market and a significant international presence, exporting its products to over 120 countries. They have a wide range of products across various therapeutic areas like oncology, antiviral, CNS, anti-inflammatory, anti-diabetic, and many more. They are also known for their R&D capabilities in generics and biosimilars.
Brief introduction about Regulatory affairs :
Regulatory affair is a profession developed from the intention of governments to protect public health by controlling the safety and efficacy of products, including pharmaceuticals, veterinary medicines, medical devices, and cosmetics so that supplied products make a worthwhile contribution to public health and welfare.
The drug development process is lengthy, complex, and extremely costly, albeit necessary.
Regulatory Affairs plays a crucial role in the pharmaceutical industry and is involved in all stages of drug development and after drug approval and marketing.
Regulatory Affairs combines science and management to achieve a commercially important goal within a drug-development organization.
It gives strategic and technical advice at the highest level in their companies,
right from the beginning of the development of a product, making an important contribution both commercially and scientifically to the success of a development program and the company as a whole.
Vacancies Information :
REGULATORY AFFAIRS job opening in Hyderabad
Education Required: B Pharma / M Pharma (Regulatory Affairs)
Experience: 01 to 3 Yrs (PRE & POST APPROVALS (E.U., U.S., ROW Markets)
In the pharmaceutical industry, the regulatory affair is a critical function that ensures that drugs and medical devices are developed, manufactured, and marketed in compliance with national and international regulatory bodies’ laws, regulations, and guidelines.
The role of regulatory affairs in the pharmaceutical industry includes:
- Preparing and submitting regulatory applications and documentation to obtain approval for developing, clinical testing, and marketing drugs and medical devices.
- Monitoring and interpreting regulatory requirements and keeping abreast of new legislation, guidelines, and policies.
- We ensure compliance with regulatory requirements at all stages of product development, from research to post-marketing surveillance.
- We collaborate with cross-functional teams, including research and development, clinical, manufacturing, and quality control, to ensure compliance with regulatory requirements.
- I am communicating with regulatory agencies and representing the company in meetings and discussions with regulatory authorities.
- We maintain records and documentation related to regulatory submissions, approvals, and compliance.
- We provide guidance and support to other departments and functions to ensure compliance with regulatory requirements.
Overall, Regulatory Affairs professionals play a key role in bringing new therapies and medical devices to the market by ensuring that they meet the required safety and efficacy standards and comply with the regulations of the country where it is marketed.
Area of Work: PRE & POST APPROVALS (E.U., U.S., ROW Markets)
Work Location: Hetero Labs Limited, Unit VII, Plot No: 14, Jeedimetla, Qutubullapur(M), Medchal Dist., Hyderabad. T.S.
Last Date: 20th April 2023
APPLICATION PROCESS; Interested candidate Please share your updated CV with premkumar.m@hetero.com or kindly refer any of your friends /Colleagues. Meanwhile, feel free to contact me at 9059611851 for any queries.
Hetero regulatory affairs job openings in Hyderabad