Regulatory Management
Specialist @ MERCK
Qualification, Experience & Skills:
Education and Languages:
1.
Master of Pharmacy/ Master / Ph.D. in life
sciences or related science. Bachelor/Masters degree in life science related
discipline.
2.
Fluent in English & Hindi (verbal and
written) is required.
Professional
Skills and Experiences:
3.
Minimum of 5-9 years of relevant industry
experience and/or regulatory management related to biopharmaceutical products,
pharmaceutical substances, process materials & life science.
4.
Knowledgeable of drug regulations and
regulatory landscape of other important country/regions (eg. US & European
Countries) including India
5.
Proven knowledge of cGMP, FDA, EMA, ISO 9001
standards, regulatory and compliance requirements, aseptic processing and
validation procedures.
6.
Experience working in a global, matrix
environment.
Personal
Skills and Competencies:
7.
Good presentation skill.
8.
Strong organizational and time management
skills.
9.
Good project management skills.
10.
Ability to train and educate others.
11.
Effective management by influence.
12.
Effective people management.
13.
Some experience in thought leadership.
14.
Ability to work in multi-cultural teams.
15.
Good listening skills with the ability to
analyze and respond to given situations quickly and effectively.
16.
Excellent interpersonal, presentation,
listening and communication skills that will develop long term internal and
external relationships at all levels.
17.
Ability to indirectly influence other
organizations and cultures.
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