Operation Lead consultant

Job Title: Operation Lead consultant

Location : Remote

Duration : 11 Months

Interview Mode : Video

Job Description :

• Typically a minimum of -3 years relevant regulatory experience within a regulatory function
• Experience with RIM, Submission Management or Publishing tools

1. Competencies

• Strong Knowledge and demonstrated understanding of following:

o Client Regulatory Standards o Client 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

1. 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

1. 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

1. 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

1. 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

1. Experience

• Typically a minimum of -3 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