Associate Director, Regulatory Affairs

Job Description

 Under minimal guidance of the Senior Director, Business Development Execution, the incumbent coordinates cross-functional

Global Regulatory Affairs and Clinical Safety (GRACS) activities to implement and maintain regulatory obligations for assigned Company Business Development (BD) agreements (e.g., divestitures, mergers/acquisitions, in-licensing, out-licensing, collaborations, co-marketing, authorized generics; broader deal types as applicable). The role facilitates processes, communications, and governance so GRACS contractual commitments are met while maintaining regulatory compliance.

 

Key Responsibilities

 

1.     Lead GRACS Integration/Transition teams for assigned deals: recruit and onboard team members; facilitate planning and milestone alignment, risk/issue identification, and progress tracking against deal implementation project plans following the GRACS Business Development Execution Playbooks and related tools.

 

2.     Work closely across functions to support the migration of content from/to the partner in support of in-scope systems and tools for GRACS, working closely with vendor and IT to execute the task effectively and within the agreed timelines.

 

3.     Coordinate with Corporate Business Development, Company Research Labs, Global Alliance Management (MGAM), Integration Management Office (IMO), and GRACS BD to understand agreement obligations and timelines.  Align across the division's functions.

 

4.     Serve as point of contact for ongoing operational alliance-related questions within GRACS scope; coordinate responses and escalate issues appropriately.  This includes, but is not limited to, ongoing relationship management, issue resolution, oversight, and partner alignment of working methods to support GRACS.

 

5.     Support the ongoing maintenance of deal-related documentation, updates, and communications in the appropriate systems; prepare concise status summaries for GRACS leadership as needed.

 

6.     Oversee deal integration, transition, and partnership-related risk and issues to investigate and identify causes, gather and process relevant information, generate possible solutions, make recommendations, and/or resolve the problem and direct the resolution of complex business problems through a documented Escalation pathway for the deal.

 

7.     Support adherence to GRACS collaborative frameworks and share best practices; contribute to continuous improvement by capturing lessons learned and proposing enhancements to execution tools. 

 

8.     Work across Business Development Execution Operations to drive projects to improve operations of the team based on lessons learned and outcomes from risk/issue resolution efforts.

 

Education:

Bachelor's Degree preferably in technical, business, or science.

Strong proficiency in English, including verbal, reading, and writing skills.

 

Required Experience:

·       At least 8 years in the pharmaceutical industry with at least 5 years in Regulatory/Pharmacovigilance Function or Alliance Management.

·       Understanding of regulatory and clinical processes for pharmaceutical products, vaccines, and/or biologic products.  Working knowledge of regulatory concepts, requirements, and the overall process of product lifecycles

·       Strong virtual and in-person collaboration

·       Demonstrated facilitation and leadership skills.

·       Clear communicator and goal-oriented.

·       Comfort and experience in building and presenting effective slide presentations with audiences at all levels of the organization.

·       Independent thinker and worker.  Highly organized, motivated, and detail-oriented while still able to keep an overall "big picture" view of projects and strategies.

·       Demonstrated analytical and data management skills.  Experience pulling together abstract milestones and data into a centralized management report.

·       Demonstrated ability to lead cross-functional teams and facilitate cross-functional meetings to achieve a purpose.

·       Strong, demonstrated project management capabilities and skills.  Ability to collaborate and manage multiple projects at various stages of the process simultaneously.

·       Ability to communicate messages clearly and concisely, both verbally and in writing. Experience with change management concepts and execution. 

·       Strong proficiency with generating content using all MS Office tools, including but not limited to Word, Excel, Power-Point and SharePoint.

·       Some experience creating and modifying MS Teams and MS Project or related tools to manage project timelines and collaboration.

·       Ability to effectively work seamlessly with all levels of personnel.

·       Demonstrated sensitivity and knowledge of Diversity and Inclusion principles.

 

Desired Experience:

·       Experience with Alliance Management and/or Regulatory operations and process for partnerships (multiple deal or execution types) preferred.

·       Experience with partnerships, contracts, and agreements

Project Management Professional (PMP) Certification and/or Six Sigma Green or Black Belt.

Required Skills:

Accountability, Accountability, Adaptability, Biopharmaceutical Industry, Business Development, Change Management, Contract Management, Cross-Cultural Awareness, Data Management, Detail-Oriented, Diversity and Inclusion (D&I), Documentations, Employee Training Programs, FDA Regulations, In Licensing, Mentorship, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Out Licensing, Pharmacovigilance, Policy Implementation, Product Lifecycle, Project Management, Regulatory Compliance {+ 5 more}

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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

01/31/2026

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