Biocon Biologics Hiring 2022 Graduates for National Regulatory Affairs Biologics At Bangalore Urban, Karnataka, India . Biocon Biologics Notification full details below..Interested and eligible candidates can Apply Now.
- Vacancy details:
- Post Name: National Regulatory Affairs Biologics
- Qualification: Graduates
- Experienced:8 to 12 years
Job Description: Biocon Biologics Hiring For National Regulatory Affairs Biologics !
- Important Details :
- Location: Bangalore Urban, Karnataka, India
- Post of date: 21/06/2022
- Selection Process: The selection will be on the basis of Interview.
Roles and Responsibilities
At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long term commitment to bring high quality affordable biosimilars to patients all over the globe. We have proven end to end expertise from clone development, manufacturing, clinical development, regulatory approvals to commercialization in developed and emerging markets.
Role is based out of National Regulatory Affairs will be responsible for managing and controlling the regulatory support and guidance to project teams and regulatory staff and preparing and submitting India regulatory agency for approval related to Biosimilar products. Responsible for all regulatory and labeling compliance the marketed products. Responsible for interaction with regulatory authorities to obtain licenses, maintenance of license. Should be able to recommend efficient strategies. Manages and provides strategic directions oversight to country based regulatory team members.
- In depth practical knowledge of submissions to CDSCO, IBSC, RCGM for manufacture and import of biosimilars & pharmaceutical drugs
- Should have experience in follow-ups / meetings with the health authorities
- In-depth knowledge of Drugs & Cosmetics Act and Rules, NDCT 2019 and various guidance issued by DCGI / Ministry of Health.
- Expertise in the CMC requirement from drug development process, marketing and till post approval activities (product lifecycle management) including CMO site addition on LL basis.
- Experience in providing Labelling text matter, review of artwork (Label, Carton and PI) for India market as per the current Rules & regulations.
- Coordination with govt. testing labs for timely release of products
- Interactions with health authorities for building / maintaining trust and obtaining timely approvals Handling of Customer/ Regulator`s complaints/issues
- Ability to work on complex projects and within cross-functional teams and solution-oriented approach to problem solving for ensuring timely deliverables.
- Provide regulatory guidance and support to project teams including regulatory filing strategies, testing and standards requirements and support RA staff in filing process.
- Knowledge in preclinical and clinical studies (protocol review etc) including Pharmacodynamics studies, toxicology studies, Pharmacokinetic studies.
- Good communications skills (Both verbal & written), understand sense of urgency, be self-starter, go & getter.
- Updating the team about all the latest gazette notifications, acts and amendments to Indian Drugs and Cosmetics Act, the rules and regulations.
- Review, provide feedback for manufacturing changes, nonconforming materials reports, test protocols and reports to ensure regulatory compliance with Indian regulatory and applicable standards, and determine filing requirements.
- Review promotional and advertising materials, complaints, lead vigilance and MDR reporting efforts if any.
- To work with Distribution & Warehousing to ensure Good Distribution Practices
- Respond to requests from regulatory authorities.
- Conduct conference calls, meetings and presentations with CFTs and reviewers as needed.
- Develop regulatory processes and procedures as needed.
- Understand the job specific quality system procedures and processes as defined in the Training
- Matrix and adhere to the requirements listed in those documents. If any of the procedure or process requirements are unclear or ambiguous, it is the responsibility of the employee to notify his/her supervisor or Quality Assurance
- Maintain corporate confidentiality at all times
- Other duties as assigned.
8-12 yrs experience
Master degree (Pharma or life sciences)
- Proven ability to consistently deliver to time, cost and quality standards.
· Demonstrable experience of effective delivery in a complex matrix environment.
· Knowledge of manufacturing related to Indian regulatory laws and guidelines
- Knowledge of quality systems and processes pertaining to GMP (Good Manufacturing Practices)
· Knowledge of Artwork and labeling related to Regulatory and Pharmacopoeial requirements.
· Knowledge of different Forms to be used for application for grant of Mfg. license.
· Knowledge of different schedules of D & C act particularly Schedules C,C1,G,H and M
- Technical medical terminology and its usage
· Simultaneous, multiple project handling capacity
How to Apply :
Step 1: Click on below link and you will be redirected to Career Page of Recruiting Company or Career portal.
Step 2. Register on Career Page of the Company or Career Portal by giving log in credentials and other personal or education details .
Step 3.Upon successful registration .User need to log in with credentials.
Step 4.Once logged in, User need to fill the all relevant personal ,educational , Work experience details ,attach resume and submit application form.