Specialist- Regulatory affairs

Job Description

Title: Specialist- Regulatory affairs

Company Name: Sinovac Biotech (Bangladesh) Limited

Vacancy: Not specific

Job Location: Dhaka

Employment Status: Full-time

Educational Requirements:
∎ Bachelor of Science (BSc) in Pharmacy, Master of Science (MSc) in Pharmacy
∎ B.Sc/M.Sc in Biochemistry/ Molecular Biology/ Biotechnology/ Genetic Engineering.

Experience Requirements:
∎ 3 to 5 year(s)
∎ The applicants should have experience in the following area(s): Corporate Affairs, International Affairs, Legal Affairs
∎ The applicants should have experience in the following business area(s): Pharmaceuticals

Job Responsibilities:
∎ To prepare, compiling and reviewing the scientific and legal documents such as; manufacturing license, product registration and renewal, market authorization and price approval.
∎ Reviewing company policies, practices, systems and offering advice.
∎ Keep up to date with national and international legislation, guidelines and customer practices.
∎ Dealing, liaising and negotiating with national and international regulatory authorities.
∎ Maintain and closely deal with recipe preparation and approval related issues.
∎ Maintain block list and indent preparation and approval.
∎ Gathering, evaluating, organizing, managing and collating information in a variety of formats, analyzing complicated information, including trial data.
∎ Writing comprehensible, user-friendly, clear product information leaflets and labels.
∎ Deal with medical device registration and renewal as per policy.
∎ Handling the quires from regulatory authorities during the registration process.
∎ Contributing to various product strategic plans regarding timing, opportunities and risk assessment regarding to regulatory matters.
∎ Ensuring compliance with regulations set by the DGDA, different Medicines and Healthcare products Regulatory Agency.
∎ Planning, undertaking and overseeing product trials and regulatory inspections.
∎ Keeping up-to-date with changes in regulatory license process, regulatory legislation and guidelines.
∎ Ensuring that quality standards are met and submissions meet strict deadlines.
∎ Planning, undertaking and overseeing product trials and regulatory inspections.
∎ Any other task assigned by higher authorities.

Additional Requirements:
∎ Age 26 to 35 years

Salary: Negotiable

Compensation & Other Benefits:
∎ T/A, Mobile bill
∎ Festival Bonus: 2
∎ As per company policy.

Job Source: Bdjobs.com Online Job Posting.

Application Deadline: 29 Apr 2023

Company Information:
∎ 30 Mar 2023
∎ Sinovac Biotech (Bangladesh) Limited
∎ Address : House 16/B, Road 93, Gulshan 2, Dhaka 1212
∎ Business : Sinovac Biotech Ltd., is a high-tech biopharmaceutical company headquartered in Beijing. Through its wholly owned subsidiary, Sinovac Biotech (Hong Kong) Limited, Sinovac Biotech Co., Ltd. owns five branches as well as four production bases located in Haidan, Changping and Daxing districts of Beijing, and Dalian of Liaoning. Following the mission of “Supply Vaccines to Eliminate Human Diseases", Sinovac is committed to the research, development, manufacturing and commercialization of vaccines for humans, as well as providing services for disease control and prevention.
Product Protfolio: The Covid-19 Vaccine (Vero Cell), Inactivated (CoronaVac®); Enterovirus Type 71 Vaccine (Vero Cell), Inactivated (Inlive®, a new drug under “Category 1 Preventative Biological Products); China’s first WHO pre-qualified Hepatitis A Vaccine (Human Diploid Cell), Inactivated (Healive®), etc.
In Bangladesh, Sinovac Biotech Ltd. planned to produce PDMPs establishing a pharmaceutical industry which will use the human plasma as raw material. The plasma is planned to be collected by a huge number of blood banks.

Category: Other Special Skilled Jobs

: The person who have the experience about biologics or biological products registration, have related work experience and strong background regarding this will get preference.