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Inviting applications for the role of Specialit - Regulatory Affairs -Operations

**Work Location**: Mumbai

Responsibilities

Responsible for leading and executing CMC regulatory strategies for assigned postapproval pharmaceutical products in alignment with global regulations, guidance and defined regulatory strategies, including preparation and critical review of data and documents required for postapproval CMC submissions and lifecycle management.

- Accountable for authoring, reviewing, and coordinating CMC documentation to support worldwide postapproval changes and lifecycle activities (variations, supplements, amendments) for commercial products, under the strategic direction of senior regulatory CMC scientists or product leads.
- Experienced in evaluating scientific and technical information to assess the merits and regulatory impact of proposed postapproval changes, ensuring that rationales are clearly articulated, riskbased, and fully supported by appropriate data.
- Able to prioritize, plan, and drive multiple CMC postapproval projects in parallel, ensuring timely preparation, review, and submission of highquality dossiers in line with agreed project plans, regulatory timelines,



and internal milestones.
- Works effectively with crossfunctional teams (e.g., QA, QC, manufacturing, supply chain, packaging, device, and analytics) to track and close out documentation gaps, coordinate on change implementation status, and provide clear, concise regulatory updates to stakeholders through appropriate communication channels.
- Demonstrates strong written and verbal communication skills, including the ability to translate complex technical concepts into clear regulatory justifications and to influence decisionmaking in crossfunctional 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 crossfunctional 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 timesensitive 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, RIMS, and tracking tools) to efficiently prepare, manage, and archive CMC regulatory documentation.





Qualifications we seek in you!

Minimum Qualifications

- Bachelor's Degree or higher in life sciences field.

Preferred Qualifications/ Skills

- Bachelor's or Master's degree required in Pharmacy, Science, or related field (advanced degree preferred) with global Regulatory CMC experience
- Research and stay updated on regulations relevant to the industry. Develop and implement compliance policies and procedures.
- Conduct internal audits and risk assessments. Provide guidance and training to staff on compliance matters.
- Monitor and report on compliance issues to management.
- Collaborate with legal and other departments to address compliance concerns.
- Respond to compliance inquiries from regulatory authorities.

Why join Genpact?

- Be a transformation leader Work at the cutting edge of AI, automation, and digital innovation
- Make an impact Drive change for global enterprises and solve business challenges that matter
- Accelerate your career Get hands-on experience, mentorship, and continuous learning opportunities
- Work with the best Join 140,000+ bold thinkers and problem-solvers who push boundaries every day
- Thrive in a values-driven culture Our courage, curiosity, and incisiveness - built on a foundation of integrity and inclusion - allow your ideas to fuel progress

Come join the tech shapers and growth makers at Genpact and take your career in the only direction that matters: Up.

Lets build tomorrow together.

Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values respect and integrity, customer focus, and innovation. Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a 'starter kit,' paying to apply, or purchasing equipment or training.

📌 Specialist - Regulatory Affairs - Operations (Nashik)
🏢 Genpact
📍 Nashik