Verified Job
Healthcare
Sr. Specialist - Regulatory Affairs - Operations 4C
Healthcare
#48262
Remote / WFH
Genpact India Pvt. Ltd.
Job Description
Responsibilities:
• Responsible for leading and executing CMC regulatory strategies for assigned post‑approval pharmaceutical products in alignment with global regulations, guidance and defined regulatory strategies, including preparation and critical review of data and documents required for post‑approval CMC submissions and lifecycle management.
• Accountable for authoring, reviewing, and coordinating CMC documentation to support worldwide post‑approval changes and lifecycle activities (variations, supplements, amendments) and responses to health authority questions for commercial products per established business processes and systems.
• Provide regulatory leadership as needed to product in-license/due diligence review, product divestment and product withdrawal.
• Collaborate effectively with cross‑functional teams (e.g., QA, QC, manufacturing, supply chain, packaging, device, and analytics), CMOs, and external partners to track and close out documentation gaps, compliant execution of change management, and conduct all activities with an unwavering focus on regulatory conformance.
• Ensure timely approvals for the submissions and Product supply continuity.
• Deliver all regulatory milestones for assigned products across the product lifecycle.
• Strong experience in CMC requirements for small molecule/biologic products.
• Proven experience in critically reviewing detailed scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
• Demonstrates strong written and verbal communication skills, including the ability to translate complex technical concepts into clear regulatory justifications and to influence decision‑making in cross‑functional and global forums.
• Shows sound understanding of related technical disciplines (such as pharmaceutical manufacturing, analytical testing, quality assurance, and quality systems) and applies this knowledge when defining regulatory strategies and compiling CMC dossiers.
• Proven ability to identify regulatory risks and opportunities, generate innovative yet compliant solutions to issues, and collaborate effectively with internal and external partners to align on regulatory pathways.
• Active participation in departmental and cross‑functional continuous improvement initiatives such as enhancement of templates, processes, systems; maintenance of standard operating procedures and internal guidelines etc.
• Demonstrates flexibility and resilience in managing changing priorities, unforeseen regulatory queries or health authority expectations, and time‑sensitive projects, while maintaining accuracy and compliance.
• Exhibits strong leadership, stakeholder management, and interpersonal skills, including mentoring junior colleagues and representing CMC regulatory function in project and governance meetings.
• Possesses advanced working knowledge of MS Office and relevant regulatory/quality IT systems (e.g., document management, Veeva Vault, RIMS, and tracking tools etc.) to efficiently prepare, manage, and archive CMC regulatory documentation.
• Demonstrates effective leadership, communication, interpersonal and negotiating skills.
• Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines.
Qualifications
Bachelors - Health Administration, Bachelors - Healthcare, Bachelors - Pharmacy, Masters - Public Health, Masters - Regulatory Affairs
Certifications
Certified Compliance Officer (CCO) - VskillsVskills, Certified Public Accountant (CPA) - Perfekt SzolnokPerfekt Szolnok, Certified Regulatory Compliance Manager (CRCM) - The International Association of Risk and Compliance Professionals (IARCP)The International Association of Risk and Compliance Professionals (IARCP)
Required Skills
Client Relations, Collaboration Tools, Data Analytics, Executive Presence, Generative AI, Lean Six Sigma (LSS), Microsoft Azure, People Leadership, Personal Effectiveness, Storytelling
Language
English (Required)
Language Proficiency -
Proficient - C2
Additional Job Location -
Job Type
Regular
Master Skill List -
Regulatory Affairs - Operations
Remote Type -
Office
Work Shift -
Flex Time (India)
• Responsible for leading and executing CMC regulatory strategies for assigned post‑approval pharmaceutical products in alignment with global regulations, guidance and defined regulatory strategies, including preparation and critical review of data and documents required for post‑approval CMC submissions and lifecycle management.
• Accountable for authoring, reviewing, and coordinating CMC documentation to support worldwide post‑approval changes and lifecycle activities (variations, supplements, amendments) and responses to health authority questions for commercial products per established business processes and systems.
• Provide regulatory leadership as needed to product in-license/due diligence review, product divestment and product withdrawal.
• Collaborate effectively with cross‑functional teams (e.g., QA, QC, manufacturing, supply chain, packaging, device, and analytics), CMOs, and external partners to track and close out documentation gaps, compliant execution of change management, and conduct all activities with an unwavering focus on regulatory conformance.
• Ensure timely approvals for the submissions and Product supply continuity.
• Deliver all regulatory milestones for assigned products across the product lifecycle.
• Strong experience in CMC requirements for small molecule/biologic products.
• Proven experience in critically reviewing detailed scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
• Demonstrates strong written and verbal communication skills, including the ability to translate complex technical concepts into clear regulatory justifications and to influence decision‑making in cross‑functional and global forums.
• Shows sound understanding of related technical disciplines (such as pharmaceutical manufacturing, analytical testing, quality assurance, and quality systems) and applies this knowledge when defining regulatory strategies and compiling CMC dossiers.
• Proven ability to identify regulatory risks and opportunities, generate innovative yet compliant solutions to issues, and collaborate effectively with internal and external partners to align on regulatory pathways.
• Active participation in departmental and cross‑functional continuous improvement initiatives such as enhancement of templates, processes, systems; maintenance of standard operating procedures and internal guidelines etc.
• Demonstrates flexibility and resilience in managing changing priorities, unforeseen regulatory queries or health authority expectations, and time‑sensitive projects, while maintaining accuracy and compliance.
• Exhibits strong leadership, stakeholder management, and interpersonal skills, including mentoring junior colleagues and representing CMC regulatory function in project and governance meetings.
• Possesses advanced working knowledge of MS Office and relevant regulatory/quality IT systems (e.g., document management, Veeva Vault, RIMS, and tracking tools etc.) to efficiently prepare, manage, and archive CMC regulatory documentation.
• Demonstrates effective leadership, communication, interpersonal and negotiating skills.
• Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines.
Qualifications
Bachelors - Health Administration, Bachelors - Healthcare, Bachelors - Pharmacy, Masters - Public Health, Masters - Regulatory Affairs
Certifications
Certified Compliance Officer (CCO) - VskillsVskills, Certified Public Accountant (CPA) - Perfekt SzolnokPerfekt Szolnok, Certified Regulatory Compliance Manager (CRCM) - The International Association of Risk and Compliance Professionals (IARCP)The International Association of Risk and Compliance Professionals (IARCP)
Required Skills
Client Relations, Collaboration Tools, Data Analytics, Executive Presence, Generative AI, Lean Six Sigma (LSS), Microsoft Azure, People Leadership, Personal Effectiveness, Storytelling
Language
English (Required)
Language Proficiency -
Proficient - C2
Additional Job Location -
Job Type
Regular
Master Skill List -
Regulatory Affairs - Operations
Remote Type -
Office
Work Shift -
Flex Time (India)
