Job Description: Responsibilities
A. Competencies
Strong Knowledge and demonstrated understanding of following:
o Genpact Regulatory Standards o Genpact Regulatory Practice o Departmental standard operating procedures o Business Practices
o Client standards, practices, policies and business
Strong knowledge of the drug development process, regulatory affairs, and submissions management
Ability to work independently with minimal supervision
Ability to work under pressure and meet business critical deadlines
Experienced problem solver
Ability to critically analyse technical and/or scientific issues
Ability to offer support, guidance and coaching to junior team members
B. Skills
Excellent written and verbal communication - English essential, other languages desirable but not required unless regionally specified
Good organizational skills
Flexible and adaptable to change
Demonstrates good judgement and business acumen working with clients or internal teams
Strong interpersonal skills
Ability to negotiate, influence others and work in a cross functional team
Ability to work under pressure and meet business critical deadlines
Highly familiar with regulations and guidelines in the US, EU and/or MOW markets
Networking Skills
Ability to objectively assess personal strengths and weaknesses adjust to improve performance
Good Project Management skills

C. Training
Mastery of MS Office Skill-Set: Word, Excel and other tools as appropriate
Core Professional Skills Training (e.g. corporate etiquette, email writing, etc.)
Regulatory Affairs University (completion of GSA related tracks)
Experience with Document Management, Regulatory Information Management, Publishing or other related systems
Additional Professional Skills as applicable (Presentation Skills, Project Management)
Train the Trainer (as applicable)
Lean Six Sigma Trained, Tested / Greenbelt Training

D. Characteristics
Self-motivated, hard-working, proactive, good interpersonal skills, builds global relationships, displays good judgment
Learns quickly, actively listens, adjusts and improves by considering and processing constructive feedback,
Works in a positive collaborative manner with all level colleagues, peers and clients
Demonstrates business acumen and has strong problem solving skills

E. Qualifications & Certifications
Bachelor s Degree (or equivalent) in any Discipline may be acceptable
Master s Degree, PhD or another advanced degree (or equivalent) beneficial at this level but not essential

F. Experience
Typically a minimum years relevant regulatory experience within a regulatory function
Experience with RIM, Submission Management or Publishing tools
Demonstrated experience in Operational role Data Management, Publishing, Submissions Management
Solid Project Management skills
Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards
Additional Sills:

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