Senior Manager GRAAS Operations
About this opportunity
Career Category
Regulatory
Job Description
The Global Submission and Information Management (GSIM) team designs and implements process improvements, digital technologies, data standards, training, and organizational change management to deliver business results
The Regulatory Data & Systems Senior Manager is a key position responsible for executing the strategic vision of our regulatory technology landscape. This role involves leading a team, providing subject matter expertise, and collaborating with stakeholders to help drive innovation and efficiency in regulatory affairs. The Senior Manager will also be responsible for helping to deliver continuous improvement to enterprise regulatory systems, streamlining data models, and influencing vendor partnerships to ensure regulatory compliance and deliver measurable business results.
Roles & Responsibilities:
Leadership: Execute the strategic roadmap for regulatory information systems, aligning technology initiatives with organizational goals and regulatory compliance requirements.
Subject Matter Expertise: Serve as an in-house subject matter expert (SME) on regulatory information management, keeping abreast of evolving regulatory landscapes and technology trends.
System Process Simplification: Identify opportunities to simplify and streamline system-based processes and user interfaces
Team Leadership: Lead a team of professionals responsible for the implementation, maintenance, and continuous improvement of regulatory information systems and data management processes.
Vendor Management: Collaborate with external vendors and technology partners to optimize system capabilities and influence product roadmaps to meet organizational needs.
Data Model Expertise: Serve as a data model expert with a focus on IDMP, ensuring that the organization's regulatory information aligns with evolving data standards and requirements
Enterprise User Base Support: Provide guidance, training, and support to a large user base, ensuring successful utilization of regulatory information systems.
Compliance Assurance: Ensure that all regulatory information systems and adhere to relevant regulatory requirements, standards, and data security protocols.
Required Knowledge and Skills:
Leadership: Execute the strategic roadmap for regulatory information systems, aligning technology initiatives with organizational goals and regulatory compliance requirements.
Subject Matter Expertise: Serve as an in-house subject matter expert (SME) on regulatory information management, keeping abreast of evolving regulatory landscapes and technology trends.
System Process Simplification: Identify opportunities to simplify and streamline system-based processes and user interfaces
Team Leadership: Lead a team of professionals responsible for the implementation, maintenance, and continuous improvement of regulatory information systems and data management processes.
Vendor Management: Collaborate with external vendors and technology partners to optimize system capabilities and influence product roadmaps to meet organizational needs.
Data Model Expertise: Serve as a data model expert with a focus on IDMP, ensuring that the organization's regulatory information aligns with evolving data standards and requirements
Enterprise User Base Support: Provide guidance, training, and support to a large user base, ensuring successful utilization of regulatory information systems.
Compliance Assurance: Ensure that all regulatory information systems and adhere to relevant regulatory requirements, standards, and data security protocols.
Preferred Knowledge and Skills:
Advanced knowledge of Enterprise Information management systems such ERP, QMS, & Change Management,
Familiarity with global regulatory requirements and standards beyond the organization's primary market.
Proficiency in Agile methodologies, including Scrum or Kanban, to enhance collaboration, efficiency, and adaptability within an Agile work environment.
Basic Education and Experience:
Doctorate degree and 8 years of regulatory systems experience OR
Master’s degree and 10 years of regulatory systems experience OR
Bachelor’s degree and 12 years of regulatory systems experience OR
Preferred Education and Experience:
Experience with regulatory documents in Regulatory Affairs, Research, Development, Quality Management, or related area
5+ years’ experience in implementing large scale enterprise systems in the Biotech/Pharmaceutical industry
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Job details
How this role compares
Computed from every other active Pharmacovigilance role in our database, not just this employer's listings.
We currently track 41 comparable Manager Pharmacovigilance roles across 22 biopharma companies.
Salary context
7 of 41 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 41 comparable roles
+ 9 more countries
Seniority mix
41 of 41 peers have a known seniority level
Therapeutic area mix
0 of 41 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
No peers with a known therapeutic area yet.
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.