Regulatory Management Specialist @ MERCK, Master of Pharmacy/
Master / Ph.D. in life sciences or related science. Bachelor/Masters degree in
life science
Qualification, Experience & Skills:
Education and Languages:
- Master
of Pharmacy/ Master / Ph.D. in life sciences or related science.
Bachelor/Masters degree in life science related discipline.
- Fluent
in English & Hindi (verbal and written) is required.
Professional Skills and Experiences:
- Minimum
of 5-9 years of relevant industry experience and/or regulatory management
related to biopharmaceutical products, pharmaceutical substances, process
materials & life science.
- Knowledgeable
of drug regulations and regulatory landscape of other important
country/regions (eg. US & European Countries) including India
- Proven
knowledge of cGMP, FDA, EMA, ISO 9001 standards, regulatory and compliance
requirements, aseptic processing and validation procedures.
- Experience
working in a global, matrix environment.
Personal Skills and Competencies:
- Good
presentation skill.
- Strong
organizational and time management skills.
- Good
project management skills.
- Ability
to train and educate others.
- Effective
management by influence.
- Effective
people management.
- Some
experience in thought leadership.
- Ability
to work in multi-cultural teams.
- Good
listening skills with the ability to analyze and respond to given
situations quickly and effectively.
- Excellent
interpersonal, presentation, listening and communication skills that will
develop long term internal and external relationships at all levels.
- Ability
to indirectly influence other organizations and cultures.
- Proficient
in MS Office Software (Word, Excel, PowerPoint, Project).
Able and willing to travel frequently
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