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PEH Regulatory Affairs Manager


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Job Details

**Position Purpose**

The PEH RA Manager - Anden Cluster will lead, manage and provide strategic direction to develop and execute regulatory strategies and plans for the country and/or products under his/her responsibility.

He/she is expected to ensure collaborative connectivity with key internal and external stakeholders such as Regulatory Authority, Local Chamber, General Managers, Directors, etc.

**Only candidates with the following key requirements will be considered:**

+ **Minimun 5 years of relevant experience within pharma regulatory affairs in R&D pharmaceutical industry in Colombia.** Knowledge of regulatory affairs in Ecuador, Peru, Bolivia and Venezuela would be desired.

+ Pharmacist degree

+ Advanced English language level

+ Some experience leading high performing and cross country (virtual) teams would be an asset

More details about requirements below.


+ Develop and lead all regulatory strategies to support the registration of clinical trial applications, new products, line extensions, major variations and lifecycle changes of Colombia portfolio.

+ Ensure to provide strategic regulatory input into regional and global regulatory teams to achive local commercial objectives.

+ Provide startegic regulatory input to the local business base on a deep regulatory experienc, communication skills and manager behaviour anticipaiting our internal clients needs.

+ Develop strong partnerships with in-country teams (e.g. Country Managers, Medical, Marketing, Supply Chain), Regulatory Clusters, Regulatory Regional Teams to facilitate the development and implementation of registration strategies to expedite the registration of new products, line extensions and lifecycle optimization.

+ Responsible for developing and enhancing relationships with key external agencies (HA's/BoH, RKOL's, etc.). Manage the HA/BoH interface throughout the development and lifecycle of a product, developing a long-term and positive relationship characterized by Integrity, Quality, Compliance and Leadership.

+ Active participation in trade organization of country and effective communication to key stakeholders of key issues that could impact regulatory strategies of the business. Understand local regulations and developing trends in the local regulatory environment of the countries that support and provide assessment of the impact to key stakeholders.

+ Leverage regulatory intelligence / landscape knowledge to support the development and implementation of regulatory and business strategies, and decision making. Influence on new sanitary legislation initiatives that could impact the business.

+ Lead the in country/cluster regulatory team to support different commercial activities such as tenders and promotional material development and approval.

+ Lead all Andean Cluster projects representing all in country cluster teams.

**Qualifications (i.e., preferred education, experience, attributes)**

+ Pharmacist Degree. A higher degree (MS or PhD) may be an advantage but is not essential.

+ Appropriate Regulatory Experience in Colombia, minimum 5 years experience

+ Demonstrable experience across the Drug, Discovery, Development and commercialization lifecycle, with proven examples of contribution

+ Proven ability to manage complex regulatory issues

+ Proven ability to consistently deliver to time, cost and quality standards

**Technical Skill Requirements**

+ Knowledge of the Local regulatory environment and how this impacts regulatory strategy and implementation.

+ Knowledge of drug development practice, rules, regulations and guidelines.

+ Communication skills

+ Negotiation skills

+ Problem Solving

+ Understands Pharmaceutical Industry

+ Understanding stakeholder needs

+ Network and alliance building/ peer relationships

+ Influencing

+ Team working

+ Interpersonal acumen

+ Organizational agility

+ Perspective

+ Strong quality and compliance orientation

+ Analytical Thinking

+ Adaptability

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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