executive / am - regulatory affairs in bengaluru / bangalore

posted
contact
randstad india
position type
permanent
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posted
location
bengaluru / bangalore
function
Pharma, healthcare & lifesciences
position type
permanent
experience
3
reference number
64230
contact
randstad india

job description

executive / am - regulatory affairs in bengaluru / bangalore

Job Description : 

Lead end to end preparation of regulatory submissions and work in tandem with R&D, marketing, and quality teams for new product development

- Handle execution and review of all the technical documentation including but not limited to Medical device files, Design History File (DHF), Technical file (STED), FMEA (Design, process, Use), Benefit-Risk Analysis, Clinical Evaluation Report, PSUR etc

- Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing strategies

- Manage and execute pre-approval compliance activities

- Lead the audit readiness for internal and external audits and be proactive in the closure of audit non-conformances

- Develop a regulatory strategy for different markets and update strategy based upon regulatory changes

- Provide regulatory inputs to all the cross-functional teams as and when required.

- Assist in anticipating the regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions working with other teams

- Train stakeholder teams on current and new regulatory requirements to ensure organization-wide compliance

Additional responsibilities may include:

- Maintaining annual licenses, registrations, and listings

- Reviewing regulatory aspects of contracts

- Ensuring compliance with product post-approval or clearance requirements

- Reviewing labelling, advertising, and promotional materials for compliance before release

- Reviewing product claims and preserving the confidentiality of applicable product information

- Support on Indian regulatory filings


 

skills

Regulatory affairs, risk analysis

qualification

MBA/PGDM, B.Com