Ensure that all regulatory updates are shared with local and global teams in timely manner. Ensure that timely and complete regulatory actions are taken regarding assigned product/therapeutic area. Ensure operational RA tasks are executed in timely manner
Tasks & Responsibilities
- Registration of NCE and line extensions for therapeutic area of responsibility
- Strategies compliant with regulations, Liaise with Health Authority and ensure earliest submission and registration in the country.
- Follow-up regulatory approvals for the products per registration plan.
- Liaise with Health Authority regularly and engage in impactful discussion with Senior Regulatory officials.
- Ensure earliest submission & approvals at the right time to ensure quick implementation of proposed CMC changes as per global timelines.
- Renewal on time to ensure uninterrupted availability of products in the country.
- Amendments and updates are approved on time to ensure study is continued in the country and ensure timely notification of notifiable updates.
- Follow-up on submitted applications at HA.
- Regulatory Intelligence, ensure all regulatory updates are shared with local and global team in timely manner. Follow the RI procedure of making entry and impact assessment of each relevant update in RINTOOL to maintain RIN database.
Requirements
- Education: Bachelor’s degree in pharmacy or similar medical education.
- Pharma experience with regulatory focus in a multi-national for at least 8-10 years.
- Proven track record of Strong Liaising experience in the health authority
- Solid understanding of D&C; Act and Rules.
- Understanding of working practices at HA.
- Experience of direct interactions with Regulatory Authorities.
- Eye for details
- Analytical skills
- Communication skills
- Negotiation skills
- Position is based in Delhi
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JOB ID
37400
Job function
Regulatory Affairs
Career level
Experienced professionals
Organization
BI India
Working time
Full time
Job flexibility
Hybrid
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients, and communities. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law