Sr Specialist Regulatory Affairs

Job Description

The Regulatory Submissions Planner will be part of the Regional Regulatory Operations team within the Global Regulatory Affairs and Clinical Safety organization of our company.

The Regulatory Submissions Planner supports the preparation of regulatory submissions and manages registration tracking from a regulatory operations perspective, ensuring alignment with strategic target dates across the region.

As part of a cross-functional team and assigned programs, the incumbent will manage all operational activities from submission planning, and execution of submissions and/or delivery to Health Authorities.

This role requires an advance expertise and knowledge of the Latin American countries’ regulatory landscapes, including regional registration procedures and a comprehensive understanding of dossier technical requirements.

Primary Activities include but are not limited to:

• Planning, coordinating and reviewing regulatory submissions with release to Country Operations teams and/or submission to Health Authorities.

• Responsible for developing and maintaining the regulatory submission plan for the assigned projects/products and maintaining the related project milestones.

• Attend and contributes to relevant planning forums and meetings.

• Work closely with other stakeholders on assigned products/projects.

• Drive the submission assembly and delivery process with the Regional Publisher or Global Submission Publishing team to ensure timely assembly, publishing and archival of assigned products/submissions, as per the agreed timelines.

• Responsible for accessing and maintaining the regulatory systems and databases to fulfil daily functions.

• Assist in identifying opportunities to continually improve the efficiency of the submission process and participate in small-scale process improvement projects.

• Maintain knowledge on the LATAM countries’ procedures (on internal and external guidelines and standards).

Education Requirements:

• Bachelor’s degree in a Life Science, Engineering, or a related discipline.
• Pharmacy degree preferred.

Experience and Skills:

• Experience in Regulatory Operations and/or Regulatory Affairs within the pharmaceutical industry.

• Able to manage multiple priorities with proven project management skills, including coordinating dynamic timelines, negotiating and collaborating with stakeholders, and consistently following through to completion.

• Thorough knowledge of regulatory guidelines and procedures within the Latin America region is preferable.

• Excellent communication skills to manage interactions with colleagues in a multicultural environment.

• Ability to maintain a clear overview of complex processes involved in planning, managing, tracking, assembling and delivering of regulatory content, to support regulatory strategy, ensure compliance and meet informational needs of internal and external stakeholders.

• Ability to perform effectively under time pressure and to manage the impacts of any delays in timely submissions.

• Aptitude for working with complex IT systems.

Languages:

English

Portuguese

Spanish

Preferred Skills:

• Proficiency with Microsoft Office applications, particularly Excel, Teams, Power Point and SharePoint.

• Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.

• Excellent people, communication, leadership skills, and well-developed cultural awareness for involvement with cross departmental teams.

• Excellent time and project management skills.

Required Skills:

Preferred Skills:

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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