Job Description

Associate Director, Regulatory Affairs

The Associate Director, Regulatory Affairs role reports to the SSDM Director/(Sr) Director and will partner cross functionally within GRACS and cross divisionally where applicable to ensure the regulatory post-approval operations in scope of SSDM (i.e.: Renewals, Deletions, Mergers, Acquisitions, Transfers, Legal Entities changes, Site name changes, Tender Bids, CPPs, ancillary documents and artwork implementation) are planned, managed, and executed timely and accurately, issues are identified and resolved, and opportunities for improvement of the business processes are pursued.

Specific responsibilities include:

Manages the selected business processes by providing governance, leadership, and end-to-end support (critical business decisions, changes that affect business processes, roles, and responsibilities)

Serve as the point of contact and acts as a resource for process(es) design and performance.

Interprets and applies process objectives and performance metrics (establishing a baseline and trending), monitors and reports process performance against metric targets.

Ensures process documentation updates and periodic revisions.

Supports training, education, knowledge sharing and communication activities for the process.

Assess regularly the E2E process and lead or contribute to improvement or re-engineering/ simplification of the business process and related tools.

Maintains an effective interface with other relevant cross-functional and cross-divisional processes.

Represents Regulatory in cross functional/divisional projects for the regulatory planning and implementation of Marketing Authorizations Transfers (MATs), legal entity changes, site name changes, mergers & acquisitions, and advice/facilitates product transition plans execution in close cooperation with country regulatory affairs.

Performs necessary impact assessments on the regulatory information, collects and analyses regulatory intelligence that is required to develop a regulatory transition strategy and integrates it into cross-divisional planning.

Identifies and reports regulatory risks.

Drives and oversees regional scheduling and planning activities, ensures high level accuracy, and minimizes disruptions by overseeing the connections between the different stakeholders.

Secure continuous follow-up & interaction with RAI stakeholders on execution status and on tracking milestones\xe2\x80\x99 achievements of the project plans.

Manages the ongoing GRACS-Partner relationship with a focus on overall service delivery, issue management, resolution, and escalation, change management.

Defines and tracks the performance of the functional activities and service level targets by the Partner.

Maintain close and seamless working relations with the other members of the RAI community, RAI HQ teams, Regional and Country teams, Regulatory Operations, and Information Management teams and GRACS functional teams operating in the international space.

This position will manage a team of regulatory professionals.

Required Qualifications/Experience:

Bachelor\xe2\x80\x99s degree in life science, engineering, business or a related field (ideally pharmaceutical science degree)

Master\xe2\x80\x99s degree (desired)

Minimum 5-7 years\xe2\x80\x99 experience in pharmaceutical industry

Previous experience in Regulatory Affairs, CMC, compliance management or Quality, working with external partners and/or dealing directly with regulatory agencies is preferred.

Good organizational skills with a proven ability to simultaneously balance diverse activities for multiple projects.

Strong interpersonal/communication skills and capacity to work across the geographies with the high number of stakeholders.

Detail oriented, problem solving, ability to accelerate the decision-making process, project management skills (providing guidance to others in task completion and on-time deliverables)

People management (desired)

Ability to communicate effectively, both verbally and written, with others across all levels of the organization

Ability to work in a matrix organization.

Technology proficient; Interest in new tools or automatization will be needed.

Innovative mindset and design thinking skills.

No Relocation will be provided

Role to be based in APAC excluding SG (location open)

What we look for\xe2\x80\xa6

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us \xe2\x80\x94 and start making your impact today.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another\xe2\x80\x99s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace

Current Employees apply

Current Contingent Workers apply

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:

Shift:

Valid Driving License:

Hazardous Material(s):

MSD