Regulatory Affairs Sr. Manager

1101 Abbott Labs Mexico SA CV; Ciudad de México; In loco; MXN 900.000 - 1.300.000; Tempo pieno

Descrizione del lavoro

Abbott in Mexico City is seeking a Regulatory Affairs Senior Manager to oversee strategy and operations for product registrations, supplements, and periodic experience reports. You will lead cross-functional teams to ensure timely approvals and compliance throughout the product lifecycle.

The role requires 12+ years of RA experience, a Bachelor's degree (MBA preferred), and fluency in Spanish with strong English; you will interact with regulators, marketing and R&D to optimize regulatory

Competenze

• Bachelor's Degree; MBA or equivalent postgraduate qualification preferred.
• 12+ years of progressive RA experience in Pharmaceutical industry; Proven leadership experience.
• Spanish: Native; English: Medium-High to Advanced level, capable of leading discussions and presentations in international environments.

Mansioni

• Interacts with regulatory agencies to expedite approval of pending registrations.
• Serves as regulatory liaison throughout product lifecycle.
• Participates in product plan development, regulatory strategy, risk management, and CMC.
• Ensures timely approval of new drugs, biologics, or medical devices and continued approval of marketed products.
• Advises development and/or marketing teams on manufacturing changes and regulatory interpretations.

Conoscenze

RA leadership

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Formazione

Bachelor's Degree

MBA or equivalent postgraduate qualification

Descrizione del lavoro

Job Title

Regulatory Affairs Sr. Manager

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to: Career development with an international company where you can grow the career you dream of A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

Opportunity

This position works out in Mexico City office in Tlalpan, Coyoacan. With Establish Pharmaceutical Division. We are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.

Main Purpose of Role

As the Manager of the Regulatory Affairs Sub-Function, oversees the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.

What You’ll Do

• Interacts with regulatory agency to expedite approval of pending registration.
• Serves as regulatory liaison throughout product lifecycle.
• Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
• Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
• Serves as regulatory representative to marketing, research teams and regulatory agencies.
• Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.

Required Qualifications

• Education Bachelor's Degree MBA or equivalent postgraduate qualification preferred.
• Experience 12+ years of progressive RA experience in Pharmaceutical industry Proven leadership experience
• Languages Spanish: Native.
• English: Medium-High to Advanced level, both written and spoken, with ability to lead business discussions, negotiations and presentations in international environments.

Additional Information

JOB FAMILY: Regulatory Operations

DIVISION: EPD Established Pharma

LOCATION: Mexico > Mexico City : Tlalpan

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: Yes, 10 % of the Time

MEDICAL SURVEILLANCE: Not Applicable

SIGNIFICANT WORK ACTIVITIES: Not Applicable

The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.