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Regulatory Affairs Specialist Job - Argentina  

Company managed [?] Still accepting applications

Posted on : 10 April 2017

Project Description

Regulatory Affairs Specialist-REG002520

Description

MSD is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, biologic therapies, and consumer care and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.


Position Objective

Assuring quality of data and timely development and successful regulatory approval of marketing applications for new products. Oversight of all other functional units that are involved in the process of marketing applications. Ensuring effective communication between the company and Regulatory Agencies charged with the review of new applications and maintenance of existing licenses. Interprets federal and state and/or international regulations as they apply to products, financial processes, and other processes, practices and procedures. Implements policies and procedures to ensure that these are in compliance with the appropriate statutes and regulations and that regulatory reporting requirements are met. Investigates and resolves compliance problems, questions, or complaints received from other units of the company, customers, government regulatory agencies, etc. May develop and implement programs designed to increase employee awareness and knowledge of compliance policies. May audit and evaluate current policies, procedures, and documentation for compliance with government laws and regulations.

Main Responsibilities:
• The main objective of the position is to support biologic products portfolio (vaccines and fertility);

• Responsible for formulating the regional strategy for new products registration and life cycle management (LCM) in alignment with clinical plans and marketing objectives;

• Acts as an internal consultant and a facilitator for Regional GRA Franchises;

• Responsible for the implementation and operation of new products registration and life cycle management (LCM) franchising for Argentina;
• Act as Liaison together with RA Country Lead before ANMAT/ INAME to develop solutions consistent with MSD strategy and registration requirements.

Competencies
• Demonstrates effective communication skills. Accurately and effectively communicates position and information to peers, supervisors, teams and external professional contacts;

• Demonstrates strong cross-functional teamwork skills to ensure new products launch in the projected timeline mostly coordinating different involved areas activities (i.e, Product Managers, Medical Advisors, QA/QC, Supply/Logistics);

• Ability to function as a consultant to internal clients, providing then with expert advice on Regulatory issues;

• Ability to proactively analyze competitive information and strategize, collaborate and build consensus for offensive and defensive approaches with brand teams for promotional campaigns, new indications and/or strategic labeling changes for marketed products;
• Demonstrates good project management skills by monitoring project timelines ensuring filing of new products, line extensions and variations timelines are met in accordance with business objectives;

• Create new and innovative ways of doing and perceiving things, demonstrates flexibility, open-mindedness, and adaptability to a rapidly changing environment;
• Integrate effectively the expected and unexpected changes keeping in mind overall MSD interest

Qualifications

Qualifications & Experience

Education:
• Science Degree (pharmacist, biochemist, biology, biotech, genetics)
• Good level in English.

Experience:
• Consolidated experience in regulatory affairs for at least 2 years in multinational companies.
• Experience in supporting biologic products portfolio is a plus
• Good knowledge of the key processes, guidelines and framework related.

Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. MSD’s benefits are designed to support the wide range of
goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.

MSD is an equal opportunity employer, proudly embracing diversity in all of its manifestations.


Job: Regulatory Affairs Generic Job Title:Spclst, Regulatory Affairs

Primary Location: LATAM-Argentina-Buenos Aires-Vicente López

Employee Status: Regular

Travel: No

Number of Openings: 1

Company Trade Name:MSD


Job Segment: Medical, Biochemistry, Genetics, Regulatory Affairs, Biotech, Healthcare, Science, Legal