Regulatory Affairs Manager
Encontrado en: Talent CO C2 - hace 1 semana
No Relocation Assistance Offered
# 157345 - Cali, Valle del Cauca, Colombia
The Regulatory Affairs Manager - Andean Region is responsible to lead the Regulatory strategies for the Andean region in order to i) support the business development plans, ii) ensure product compliance and, iii) oversee the liaison and negotiation with the regulatory authorities and trade associations to promote Colgate interests. Be the Technical Person/Manager overseeing the compliance of the operations (manufacturing and distribution) and products (Cosmetics and Medical Devices) in Colombia. Be the point person with INVIMA
Responsibilities:
Regulatory intelligence, regulatory strategies and external influence Proactively stay up-to-date with regulation changes in the Andean region. Analyzes and communicates the impact to the key stakeholders (RA Community, Technology, E2E Supply Chain and Business). Deliver Regulatory training and guidance to raise organizational awareness and competency on fundamental Regulatory requirements. Represent Colgate at the Trade Association (ANDI) and participate in selected working groups at CASIC to influence and promote convergence of the upcoming regulatory changes. Product registration and product life cycle management Ensure that all locally produced or imported products meet the technical and legal standards for the Region and are timely authorized for placement on the market. Lead product registration in accordance with the requirements for the Andean region. This comprises managing the following aspects while not being limited to: Checking that the claim supports are adequate (clinical and technical studies) Gathering the required information to obtain registration Reviewing the artworks Manage product life cycle activities for the existing products to ensure the registers are up-to-date with the formula and label revisions. Be the liaison with INVIMA on the techno- and cosmeto-vigilance aspects for the product marketed in Colombia Act as the Responsible Person for the manufacture and distribution of Cosmetics in Colombia by providing guidance and support as follow: Validating the site Quality Master Plan and contributing to the internal compliance activities (i.e Internal Audits, Assessments, training, OSQ, Copacker Audits, etc.) Providing support in CAPA analysis for consumer complaints Providing support on special projects that allow improving GMP compliance Supporting the external audits carried out by the Regulatory agency. Ensure the compliance against the Resolution Nr. 4002 (2007) as regards to the roles and responsibilities of the Technical Director for Medical Devices (numeral 2.1) i.e.: Supporting the suppliers and distributors selection Participating in the structure of the purchasing processes for imported products Approving procedures related to storage, packaging, dispatch and distribution Ensuring that storage conditions conform and records are available Providing training as needed. Act as the Responsible Person for the manufacture and distribution of Home Care products in Colombia by providing guidance and support. Organization capabilities and process efficiency Continue to develop the Andean Regulatory Affair organization leveraging on the Leadership Principles (LIFT) and working behaviors (F.E.E.D.). Leverage on Global Regulatory Operation capabilities to drive efficiencies. Foster a Diverse Equitable and Inclusive environment Ensure timely and effective communication. Be a strong team player with ability to network and collaborate to ensure stakeholders are informed and involved appropriatelyRequirements:
Minimum 7 years’ relevant experience in a Regulatory role. In depth expertise in the regulation relevant to Cosmetic and Medical Device in the Andean Region or LATAM. Strong interpersonal and relationship-building skills; ability to engage effectively with all levels and styles of employees and management Supervisory experience; competency to successfully lead teams Effective communication and presentation skills, oral and written; high attention to detail Strong critical analysis and decision-making Solid experience with leading multidisciplinary projects Self-starter with high degree of independence Proficiency in Microsoft Office suite or Google tools (Sheets, Slides, Documents) Fluent in English Desirable Master Degree in Pharmacy.-
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