Job Description

Senior Specialist, Regional Dossier Publisher – APAC

The Senior Specialist, Regional Dossier Publisher (RDP), is a member of the Regional Regulatory Operations Department Asia Pac (RRO-AP) within the company Global Regulatory Affairs and Clinical Safety (GRACS) organization, in the Regional Regulatory Operations - Asia Pacific (RRO-AP) department.

The RDP Senior Specialist collaborates with the Regional Submission Planning team to manage regulatory submission publishing activities for assigned products and to ensure the delivery of high-quality, agency-compliant regulatory dossiers that meet stakeholders' timelines, enabling the Company's products to become available in the markets. Additionally, this role may involve providing oversight to identified external publishing vendor partners to provide support for lifecycle management submissions, ensuring the continued availability of the Company's products on the markets.

Demonstrating a high degree of competence in regulatory affairs and understanding of dossier technical requirements within the region, this role provides technical subject matter expertise to support Country RA teams with their local publishing and agency submission transmission needs.

WHAT YOU WILL DO

This role is expected to provide regional System Process & Regulatory Innovation (SPRI) support for identified GRACS RIIM tools, and partners closely with local, regional, and global stakeholders as well as domain experts within RRO to drive modernization of submission publishing processes in a holistic and integrated manner that keep pace with regulatory standards in a compliant manner. This role may be asked to participate in Inspections and Audits, to provide support, key metrics and to demonstrate core functionality of the tool(s).

Responsibilities include, but are not limited to:

• Utilize submission plans provided by Regional Regulatory Submission Planners to publish and deliver high-quality, agency-compliant regulatory dossiers that meet stakeholders’ timelines and perform subsequent dossier archival activities.
• Provide regional functional oversight to identified external publishing vendor partners supporting lifecycle management submissions within the region.

• Collaborate with other publishers within the internal team and across the regions on assigned products/projects and support other products/projects as needed to support priority and significant lifecycle submissions.
• Develop and maintain AP submission publishing templates based on country regulations.
• Provide technical subject matter expertise and associated trainings to relevant stakeholders in the publishing of agency compliant regulatory dossiers, including dossier structures and file formats, electronic submissions, and transmission (e.g., agency gateways), dossier repositories and databases.
• Keep abreast of internal and external regulatory procedures, guidelines, and policies, especially those that impact publishing activities, through self-directed learnings and participation in industry-wide discussions in partnership with other GRACS stakeholders as appropriate.
• For identified GRACS RIIM tools, provide direct support to system users within the region to build good data management practices e.g., timely and accurate data entry, explore and deploy automations for highly standardized and repetitive tasks, support additional system user trainings and system-process improvement collaborations.
• Participate in / organize in the Regional Communication forums to enable dissemination of knowledge on business processes and system changes that impact GRACS RIIM Systems.
• Where responsible for RIIM tools, represent the needs of the Region in different Change Control Boards, Communities of Practice, etc. to ensure that changes are appropriate for the region.
• Participate in system inspections and audits as needed, to provide support, key metrics and demonstrate core functionality of the tool.
• Drive modernization and innovation of regulatory submission publishing processes to improve efficiency and transparency through RIM tool optimization, work closely with local, regional, and global stakeholders and domain experts across departments and divisions.

WHAT YOU MUST HAVE

To be successful in this role, you will have:

• Bachelor’s degree in a science, information technology or Pharmacy discipline required.
• Minimum of 3-4 years’ experience in Regulatory Affairs, or 4 years’ experience in Regulatory Operations with good working knowledge of publishing requirements in the AP region and experiences with Liquent Insight Publisher and/or Lorenz DocuBridge.
• Detailed-oriented with the ability to work under tight deadlines and prioritize their own work across assigned projects and products.
• Ability to lead change, and influence others with broad organizational awareness and knowledge of touch points and interdependencies.
• Demonstrate critical thinking and problem solving skills within organizations and teams with experience analyzing information and developing actions to improve data quality and process or system improvements.
• Knowledge of the regulatory registration procedures in the AP region and other publishing tools will be beneficial.

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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.

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