Especialista de Asuntos Regulatorios

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We are searching the best talent for *Regulatory Affairs Specialist to be in Quito, Ecuador.*

Purpose:Regulatory Affairs Specialist participates in all the regulatory affairs activities in the country/ or countries under her/his responsibility. The position is responsible for the Therapeutic area and list of products and/or processes and/or countries within the country/cluster.

Principal Responsibilities

Under supervision of the Head, he/she is responsible for regulatory activities to support and grow the business in line with the company goals. This includes:
Regulatory Strategy

• Contributes to regulatory strategy for new and/or marketed products for country (ies); depending of the scope of her/his responsibilities.
• Has and oversight on submissions of variations and CCDS/Reference Labeling strategies.
• for products under his/her responsibility and assesses any impact those submissions could have on the regulatory strategy. - Follows regulatory status of competitor products and assesses impact on regulatory strategy.
• Identification of data requirements (e.g., clinical trials, CMC, stability program, local studies) and dossier/legal certificate requirements.
• Interacts and aligns with internal/local business partners (e.g. Medical Affairs, Marketing, New business opportunities, legal, etc) to contribute with product strategy, local registration and launch activities. It’s an active member of CVTs.
• Ensure that, where relevant local issues are identified as potentially impacting RA strategy.
• Discusses and aligns filing plans and timelines with regional office and LA liaisons, where it is applicable.
• Contribute to standardization/new systems and processes to ensure efficiency gains and to support business continuity.

Regulatory Policy & Intelligence:

• Provides support to the LOC Head on commenting on Health Authority policies and regulations. This position could be a member of a local trade associations and participate as needed in the meetings.
• Works closely with Regional Office, global/regional Policy/ Intelligence functions within J&J and LA liaisons, as appropriate. TV-eFRM-00496 Job Description Version 1.0

Registration Dossiers

• Interacts with Health Authorities related to pre-submission activities, review & approval processes and postapproval commitments, on behalf the regulatory affairs local head, where it is applicable.
• Addresses questions from HA related to approval process aligned with local RA head, regional office and LA liaisons.

Qualifications
Qualifications and requirements**

Minimum: degree in Life sciences (e.g., Chemistry, Biology); Pharmacists preferred, with post graduate studies; Management preferred.

• Minimum of 2-3 years of experience in Regulatory Affairs in the Industry
• Hands
• on experience in pharmaceutical product registration.
• Demonstrated leadership and organizational skills.
• Understanding of commercial business.
• Demonstrated ability to handle multiple projects.
• Working knowledge of local regulations and guidelines related to drug development and registration.
• Experience in Health Authority interactions. Ability to act as company spokesperson with Health Authorities
• Excellent verbal and written communication skills in local language
• proficiency in written and oral English.
• Must be able to develop and maintain excellent working relationships, work successfully within a team.environment and as an individual contributor.
• Proactive team player, able to take charge and follow-through. Achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment.
• Proficient use of technology including MS office programs and Internet resour