Manager Regulatory Affairs
Abbott · Mumbai · onsite · Posted 29d ago
Undisclosed8–16 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
-
- 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.
The base pay for this position is
In specific locations, the pay range may vary from the range posted.
Disclaimer: This job posting and location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
Regulatory AffairsChemistryimpact analysisRegulatory FrameworksProduct RegistrationWorkdayregulatory operationsResearchMedical DevicesRisk ManagementManufacturingoperationsLegalBusiness OperationsPharmamarketing
About Abbott
Abbott
Pharma
3.7k+
employees
1910
116 years old
Illinois City
US
About
Abbott's life-changing technology helps people live fully and offers information, medicines and breakthroughs to help manage people's health.
Industries
BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturing
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