Management & Leadership Jobs in Hyderabad, India (Now Hiring) — 2,682 open — Page 118

Sr. Specialist - Regulatory Affairs - Operations

Ready to turn bold ideas into real-world impact?
 At Genpact, we don’t just adapt to change, we lead it. AI and digital innovation are transforming the way businesses work, and we’re at the forefront of it. Genpact’s AI Gigafactory, our industry-first accelerator, exemplifies how we scale advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. Whether tackling complex challenges through large-scale models or agentic AI, our breakthrough solutions tackle companies’ most complex challenges.
 
If you thrive in a fast-moving, innovation-driven environment, love building and deploying cutting-edge AI solutions, and want to push the boundaries of what’s possible, this is your moment. 
 
Genpact (NYSE: G) is an agentic and advanced technology solutions company. We leverage process intelligence and artificial intelligence to deliver measurable outcomes. With a strong partner ecosystem and decades of client trust, we provide innovative solutions that transform how businesses run. Powered by a team with an active learning mindset and client centricity at its core, we deliver lasting value for the world’s leading enterprises.
 Get to know us at genpact.com and on LinkedIn, YouTube, X, and Facebook.

Job Description

Responsibilities 

• Monitor and develop continuous improvement proposals on the processes 
• Maintain a staff of adequately skilled resources to meet deliverables 
• Communicate issues and resolve them in an appropriate time frame  
• Ensure adherence to agreed-to work practices 
• Meet established submission timelines and quality standard.  
• Participate, as needed, on global teams to complete assignments and tasks within a  
• specific task force/project associated with labelin 
• Ensure collection of metrics  
• Improve speed to minimize the cost  
• Identify discrepancies/issues in local implementation of corporate labels and contact the  
• affiliates (if appropriate) for remediation actions 

 

Qualifications we seek in you! 

Minimum qualifications 

• Demonstrated knowledge and understanding of CCDSs, US and EU labeling, and the dynamics of Labeling Team purpose and objectives  
• Proven ability to successfully understand regulatory implications of product strategy with regards to the product label, assessment, and practical management of associated impacts  
• Ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy. Proficient in speaking publicly to senior management when required  
• Must be able to construct a Company Response (MAH response) for health authority questions  
• Masters in Life Sciences  
• Understanding of key regulatory and Labeling principles and SOPs 

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 -

Hybrid

Work Shift -

Flex Time (India)

Why join Genpact?
•    Lead AI-powered transformation – Drive innovation and solve real-world business challenges that matter
•    Make an impact – Help global enterprises solve business challenges that matter 
•    Accelerate your career – Gain hands-on experience, mentorship, and world-class learning opportunities to stay ahead
•    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 140,000+ coders, tech shapers, and growth makers at Genpact and take your career in the only direction that matters: Up.  
Let’s 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.