Regulatory Affairs Manager

hace 1 semana

Panamá, Panamá Johnson And Johnson A tiempo completo

At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity.
Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years.
Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.
When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.
We are searching the best talent for a Regulatory Affairs Manager to be in Panama City, Panama.
**Purpose**: Responsible for the overall management of the Regulatory Affairs Department and all regulatory activities to support and grow the business in line with the company goals.
Leads all the regulatory affairs activities in the country/ or countries under her/his responsibility.
**Essential Duties**:

- Management of the RA Department
- Obtain and maintain marketing authorizations - define and implement the registration strategy for new products and maintenance of products on the market.
- Participate and contribute to the country business discussions.
- Ensure fast introduction of new products and line extensions, including new indications.
- Maintain and support communications with Health Authorities and third parties.
- Ensure regulatory compliance.
- Streamline regulatory activities with other business partners.
- Influence the regulatory environment.
- People development Qualifications
- Minimum: University degree in Life sciences (e.g., Chemistry, Biology); Pharmacists preferred.
- Extensive Regulatory Affairs experience (7 years) at both operational and strategic level (Head)
- Working knowledge of local regulations and guidelines related to drug development and registration.
- Hands-on experience in pharmaceutical product registration (Head)
- Experience in Health Authority interactions.

Ability to act as company spokesperson with Health Authorities.
(head)
- Demonstrated leadership and organizational skills.
People and project management skills.
Track record of staff development.
Able to develop highly motivated and talented people (Head)
- Understanding of commercial business (Head)
- Experience in QA/QC
- Excellent verbal and written communication skills - proficiency in written and oral English
- Proficient use of technology including MS office programs and Internet resources.

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