About this role
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.
The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Regulatory Operations DIVISION: EPD Established Pharma LOCATION: India > Mumbai : BKC Building ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Keyboard use (greater or equal to 50% of the workday)