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Bogota, NJ
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Job Details

*PIH: Pfizer Innovative Health

The Colombia PIH Regulatory Affairs Manager will lead and provide strategic direction to develop and execute regulatory strategies and plans for the country and/or innovative products under his/her responsibility. He/She would represent Regulatory on the local Country Medical Council (or equivalent) to ensure collaborative connectivity with these key stakeholders (e.g. Commercial, Medical, etc), and a more focused regulatory approach to supporting country business objectives.

**Primary Responsibilities**

+ Lead and manage the development of regulatory strategies and Execute them to support the registration of new products, line extensions, major variations, lifecycle management and clinical trial applications (as applicable) for Innovative Portfolio

+ Ensure to provide strategic regulatory input into global regulatory strategies, thus providing optimal support for meeting local business objectives.

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

+ Provide strategic contribution to the country (PCO) leadership team- anticipate what Regulatory needs to contribute to achieve business objectives.

+ 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. Face before the MOH authorities

+ Active participation in trade organization of country and effective communication to key stakeholders of key issues that could impact regulatory strategies or 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

+ Ensure Marketing Authorizations (MAs) are maintained in compliance with local regulations.

**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

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

+ **Pharma Regulatory Experience of minimum 5 years** leading a Regulatory Strategy for innovative products it mandatory

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

+ Colombian Regulatory experience including knowledge of NCEs and Biological products submission processes, CTAs applications (as applicable) and product life cycle management activities.

+ Active participation in Pharma Trade Associations and/or Regulatory forum regarding new regulations

+ 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.

+ Demonstrable experience of effective delivery in a complex matrix environment.

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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