Manager Regulatory Affairs
Abbott · Mumbai Metropolitan Region
- Experience5–8 yrs
- SalaryNot disclosed
- Work modeonsite
- Posted22 Sept 2026
About Abbott
Abbott is hiring in Mumbai Metropolitan Region in healthcare. This role looks for around 5+ years of experience.
Skills
- product registration submissions
- regulatory strategy
- risk management
- chemistry manufacturing control
- regulatory compliance
- technical labeling
- legal and political acumen
The role
A regulatory affairs manager at a healthcare products company directs product registration submissions, regulatory strategy, and compliance for drugs, biologics, or medical devices, and advises development and marketing teams on labeling and manufacturing changes. The role also tracks policy changes and represents the organization before regulatory agencies.
Full job description
List the main responsibilities this role regularly performs.
As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.Interacts with regulatory agency to expedite approval of pending registration.Serves as regulatory liaison throughout product lifecycle.Participates in some of the following : product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.Serves as regulatory representative to marketing, research teams and regulatory agencies.Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
For example you may consider to add :
Policy Tracking : Monitor new or changing laws, regulatory frameworks, and government proposals.Impact Analysis : Assess how regulatory shifts affect business operations, products, or company assets.Position Development : Draft official policy interpretations, corporate stances, and defense strategies for regulators.External Representation : Speak for the organization in industry associations, trade groups, and public policy forums.
Required Skills
Legal and Political Acumen : Strong understanding of how legislative bodies and regulatory agencies operate.Communication : Ability to translate dense legal text into clear, persuasive briefs for executives and external agencies.Skill in collaborating with cross-functional teams and external stakeholders.