Mindblowing Jobs

Mgr, Regulatory Consulting (Office based)

By Admin · Regulatory Affairs

HYDERABAD (IN)HYBRIDPOSTED: 10/1/2026
PHARMAFull-time
HIRING ORGANIZATIONSYNEOS HEALTHBiopharmaceutical / Healthcare Services
Syneos Health

ROLE OVERVIEW

Manager, Regulatory Consulting leads regulatory consulting projects, regulatory submissions, client engagements, project teams, and people-management activities while providing strategic and operational regulatory advice across pharmaceutical and related product development programs.

ROLE DEFINITION & RESPONSIBILITIES

  • •Contribute to regulatory submission planning for assigned regions, countries, and projects
  • •Manage day-to-day regulatory project teams and projects
  • •Provide line management, coaching, mentoring, performance management, and professional development support to staff
  • •Act as a regulatory representative across departments and as a key contact for clients and regulatory authorities
  • •Support business development, repeat business, and proposal development
  • •Develop, review, and monitor project budgets and client invoicing
  • •Provide regulatory advice and strategic and operational guidance to clients
  • •Conduct regulatory research and lead client or regulatory-agency meetings
  • •Prepare and manage IND, product registration, and post-approval regulatory submissions and documents
  • •Support quality improvement, regulatory systems, infrastructure, and internal training
Reporting Hierarchy: Reports to regulatory consulting leadership; manages regulatory project teams and direct/indirect staff; serves as a key point of contact for clients and regulatory authorities

* Role responsibilities and qualifications synthesized based on industry benchmark standards.

QUALIFICATIONS & REQUIREMENTS

REQUIRED QUALIFICATIONS

  • M.Pharm qualification is mandatory for the India-specific requirement stated in the posting
  • 4-5 years of Regulatory Affairs experience
  • Experience as a Regulatory Lead managing a product portfolio
  • Hands-on CMC authoring experience
  • Experience with post-approval variations, lifecycle management, and CMC change controls
  • Regulatory experience with EU, GCC, and Australian markets
  • Prior team-handling or people-management experience
  • Strong written and verbal English communication

PREFERRED QUALIFICATIONS

  • •BS degree in a science-related field or equivalent relevant experience
  • •Experience with IND, PMA, NDA, MAA, and CTD submissions
  • •Experience with electronic regulatory submissions
  • •Experience with ODD, PIP/PMP, or other niche submissions
  • •APAC or US regulatory experience
  • •Pharmaceutical or medical-device product-development knowledge
  • •Advanced Microsoft Office skills

REQUIRED VERIFIED SKILLS

Regulatory Affairs
CMC
regulatory submissions
IND
NDA
MAA
PMA
CTD
post-approval variations
lifecycle management
CMC change controls
regulatory strategy
regulatory consulting
regulatory research
project management
people management
budget management
client management

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Career development and progression; supportive line management; technical and therapeutic-area training; peer recognition; total rewards program; inclusive workplace culture
The posting does not disclose specific salary figures. It describes total rewards and performance-related employment programs but no numerical compensation amount is provided.

ORGANIZATION CONTEXT & CULTURE

Syneos Health is a global life sciences services organization providing integrated solutions across drug development and commercialization, with Clinical Solutions teams supporting customers through regulatory, clinical, and related services.

TEAM SIZE: 25,000+ employees
INDUSTRY: Biopharmaceutical / Healthcare Services
Culture: Syneos Health emphasizes collaboration, agility, professional development, inclusion, customer-focused problem solving, and a purpose-driven approach to healthcare delivery.

EXPECTED CAREER ROADMAP

Can progress from Regulatory Consulting Manager into Senior Manager, Associate Director, Director, or broader global regulatory consulting and leadership roles, depending on regulatory expertise, client leadership, business development, and people-management experience.

APPLICATION ADVISORY

Highlight the mandatory M.Pharm qualification and 4-5 years of Regulatory Affairs experience; clearly show Regulatory Lead and product-portfolio ownership; emphasize CMC authoring, post-approval variations, lifecycle management, and change-control assessment; list EU, GCC, and Australia exposure prominently; demonstrate people management, client-facing consulting, submission strategy, and budget-management experience.
RECOMMENDED TRAINING
1/5
CMC Regulatory Affairs Certification

CMC Regulatory Affairs Certification

READY TO SUBMIT?

Verify your capability profile and matching credentials before submitting direct applications.