Regulatory Affairs Job at Vantive | Apply Now for the Senior Specialist
Vantive is hiring a Senior Specialist – Regulatory Affairs for its team in Bengaluru, Karnataka. Excitingly, this Regulatory Affairs job is designed for professionals with a Bachelor’s degree and a minimum of 2 years of regulatory experience in the medical device or pharmaceutical industry. The successful candidate will be responsible for obtaining and maintaining global marketing authorizations, managing European and US post-approval regulations (CBE/PAS/Variations), and ensuring strict adherence to global compliance standards.
- Job Title: Senior Specialist, Regulatory Affairs
- Req ID: JR – 191963
- Location: Bengaluru, India
About The Company
Vantive is a global leader in vital organ therapies, dedicated to extending lives and expanding possibilities for patients and care teams. Building on a 70-year legacy of innovation in kidney care, Vantive is transforming the dialysis experience through digital solutions and advanced services. Headquartered in its global operations network, the company fosters a community of focused and courageous professionals driven to improve patient outcomes worldwide through cutting-edge medical technology and pharmaceutical solutions.
Regulatory Affairs Job Summary
Under limited supervision, responsible for the implementation of global regulatory strategies, obtaining and maintaining marketing authorizations for product(s), and communicating general regulatory requirements in support of licensing of Vantive’s products. This Pharma Job supports regulatory activities relating to a specific portfolio of global products/projects, making it an ideal Regulatory Affairs role.
Essential Duties and Responsibilities
- With direction, develop and execute regulatory project plans
- Identify and elevate key areas of regulatory risk
- Maintain awareness of regulatory requirements; identify relevant requirements
- Maintain regulatory files in a format consistent with requirements
- Participate as an active team member and provide regulatory advice to project teams as required
- Respond to questions from regulatory authorities within strict timelines
- Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
- Maintain and update existing regulatory authorizations
- Support regulatory activities relating to a specific portfolio of products/projects
- Prepare, review, and approve labeling and SOPs
- Represent or lead Regulatory Affairs in small project teams, offering expertise related to a Regulatory Affairs job.
Qualifications for the Pharma Job
- Knowledge of regulations. Experience dealing with European and/or US post approval regulations (variations, CBE/PAS).
- Scientific knowledge
- Project management skills
- Manage multiple projects and deadlines
- Ability to multitask and prioritize
- Interpersonal and communication skills
- Negotiation skills
- Technical system skills (e.g., word processing, spreadsheets, databases, online research)
- Ability to identify compliance risks and escalate when necessary
Education and/or Experience
- Bachelor’s degree or country equivalent.
- Minimum of 2-year regulatory or equivalent experience within a pharmaceutical and/or medical device company, CRO, or similar organization, which is ideal for pursuing a Regulatory Affairs job.
