Mgr, Quality & Regulatory Affairs

This is whereyour work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today tomorrow and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together our community is driven by a culture of courage trust and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations and we hold each other accountable for delivering exceptional results.

Here you will find more than just a jobyou will find purpose and pride.

Develop and execute regulatory strategies for product registrations renewals variations lifecycle management activities and maintenance of existing product licenses across India while providing regulatory oversight and support for Bangladesh and Sri Lanka.

Lead and oversee regulatory submissions authority queries approvals and post-approval activities with health authorities including management of medical device pharmaceutical import and registration applications through applicable regulatory systems and portals such as SUGAM ensuring timely approvals and compliance with local regulatory requirements.

Establish and maintain effective relationships with health authorities distributors license holders and external regulatory stakeholders to facilitate successful regulatory outcomes..

Lead regulatory support for health authority inspections and regulatory audits coordinate responses to regulatory observations and commitments and ensure timely implementation of corrective actions in collaboration with cross-functional stakeholder.

Monitor and assess evolving regulatory requirements regulatory intelligence and industry trends across India Bangladesh and Sri Lanka; evaluate business impact and drive implementation of appropriate regulatory strategies to ensure continued compliance and business growth.

Ensure effective product lifecycle management for registered products by performing regulatory assessments and change control evaluations determining regulatory impact and reporting requirements implementing labeling and regulatory changes and ensuring timely submission of post-approval changes renewals variations and regulatory commitments to health authorities.

Provide regulatory oversight guidance and support to distributors and local representatives to ensure timely execution of registrations renewals variations regulatory notifications and compliance obligations.

Support commercialization initiatives product launches portfolio expansion importation and supply continuity activities by providing regulatory assessments and recommendations.

Review and approve labeling artwork promotional materials and regulatory documentation to ensure compliance with applicable local regulations and Baxter requirements.

Represent Regulatory Affairs on cross-functional project teams and collaborate with Global Regulatory Affairs Quality Commercial Supply Chain Marketing and other stakeholders to achieve regulatory and business objectives.

Lead develop and provide guidance to Regulatory Affairs team members fostering technical competency regulatory excellence employee development and effective execution of business and regulatory objectives.

Other assigned tasks

Qualifications:

Strong knowledge of India and South Asia regulatory requirements and registration processes including experience with CDSCO regulations regulatory submissions approvals lifecycle management activities and regulatory systems such as SUGAM.

• Strong leadership project management communication stakeholder management and negotiation skills with the ability to lead teams manage complex regulatory projects identify compliance risks and effectively collaborate within a matrix and multicultural environment.

Education and/or Experience:

• Bachelors degree in pharmacy Life Sciences Biomedical Sciences Biotechnology Chemistry Regulatory Affairs or a related scientific discipline.
• Minimum 7 years of Regulatory Affairs experience within the pharmaceutical medical device biologics nutrition or healthcare industry.
• Experience in product registrations lifecycle management and health authority interactions.
• Experience managing regulatory activities across India and working with distributors license holders or regulatory partners across South Asia in a multinational environment is preferred. Experience using Regulatory Information Management Systems (RIMS) TrackWise and other regulatory management tools is preferred.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

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