Medical Affairs
1 year ago Medical & Healthcare Hyderabad 92 views Reference: 33230Job Details
- Ensuring that all output complies with the European Medicines Evaluation Agency (EMEA) regulations, Dutch codes of practice and license conditions where necessary.
- Overseeing medical premarket approval of new chemical entities (NCEs).
- Identifying study-related regulatory and quality issues, and managing complaints and any subsequent legal actions.
- Designing and implementing campaigns such as those for disease awareness and medical education, depending on the organisation’s products.
- Participating in meetings with senior management and attending external meetings and congresses on behalf of the company.
- Developing the best possible working relationships between the organisation and stakeholders, especially key opinion leaders.
Industry
Pharmaceutical / Biotech / Clinical Research
Category
Regulatory Affairs / Pharmacovigilance
Company Description
Bharat Biotech International Limited (BBIL) is an Indian biotechnology company founded in 1996 by Dr. Krishna Ella. The company has a strong focus on research and development and has made significant contributions to the field of vaccines and biotherapeutics. BBILs state-of-the-art manufacturing facility is located in Hyderabad, India and is known for its cutting-edge technology and high production capacity. The companys portfolio of products includes vaccines for diseases such as rabies, Japanese encephalitis, cholera, and rotavirus. Additionally, BBIL is also involved in the development of vaccines for COVID-19, and has collaborated with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) to develop Covaxin, a vaccine for the prevention of COVID-19.
