Job Description

Assoc. Director, Regulatory Affairs Oncology Portafolio:

Responsible and accountable for the definition and execution of regulatory strategies aligned with cross-functional team and business priorities, planning of activities and processes related to life cycle management of products assuring the business continuity. Responsible for ensuring the policy and Regulatory compliance of processes related with the area. Active participation in the pharmaceutical industry groups and associations

Major Activities and Responsibilities

Regulatory:

• Develop and execute the Regulatory strategies for new products and future pipeline and variations assuring timely submission and flawless revision process according to local regulatory requirements and business priorities.
• Actively participate in trade associations working groups related to business priorities, providing strategic input to shape regulatory environment.
• Ensure approvals of new products as well as renewals and variations during the cycle life of the products, in accordance with the business plan.
• Ensure the compliance of Regulatory plans, foresee any risks, and establish mitigation plans to mitigate/avoid any impact in the commercialization/products availability, new products launches and line extensions.
• Liaise with local regulatory authority as required, to facilitate the review, responses to questions and approval of all local submissions in a timely manner.
• Make valuable connections across the company, collaborating with colleagues from various departments and internationally.
• Shape the global regulatory environment and contribute to improved healthcare in Colombia.
• Gain exposure to the evolving local regulatory landscape, offering ongoing professional development and learning opportunities
• Work in a collaborative way with regional liaisons to develop regulatory strategies regarding new products and future pipeline.
• Ensure the appropriate use of the data management systems in alignment with the Regulatory Affairs processes. Timely report any inconsistency/discrepancy with respect to local regulations, corporate policies and/or procedures – RISE, AMS system, CPI, REDS, Orion, Teamsites RA, and other digital initiatives.
• Provide regulatory support for cross functional activities within the affiliate e.g., Pharmacovigilance (PV), Quality, Supply etc.
• Demonstrate knowledge of, and ensure compliance to, all relevant regulatory legislation and internal procedures.
• Set quality standards, by participating in the development of appropriate SOPs and Work Instructions for affiliate activities such as submissions, marketing authorizations maintenance, agency interface, labeling etc., per requirements of the policies and applicable local regulations.

Management of direct report, as applicable:

• Sets up priorities, organizes, oversees, and monitors direct report's activities, towards divisional and regional key objectives, while ensuring the compliance with policies and standards.
• Ensures that direct reports are appropriate trained for duly performance of responsibilities.
• Provide good team management and coaching, while fosters talent development and high-performance team’s construction.
• Fosters psychological safety and well-being among the staff.
• Guarantee an adequate succession plan.
• To build an adequate promotion process for direct report.

Qualifications & Experience

• Healthcare professional (5 university years, pharmacist is preferable) or with Master’s degree in biological science, or chemistry or related discipline.
• At least 10 years of experience in Regulatory Affairs in pharmaceutical multinational companies.
• Experienced in management of OMAs and new indications in Latin-America for Regulatory Affairs and/or Experience in other areas like technical directions, quality or any management with people will be considered as a plus.
• Self-government in complex regulatory affairs projects.
• Experience building strategic and good relationships with Health Authorities, Business Units and CMC.
• Fluent Spanish is a must; fluent in English is required, fluent in Portuguese is a plus.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:
Regular
Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Hybrid
Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:
09/22/2024

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
  

Job Posting End Date:09/22/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.


Requisition ID:R312062