*Manager- Regulatory Affairs

Pharmanovia; Maharashtra; Hybrid; INR 2,500,000 - 4,200,000; Full time

Job summary

Pharmanovia in Mumbai/Vadodara seeks an experienced Manager Regulatory Affairs to lead global regulatory activities for development, registration and maintenance of pharmaceutical products. You will ensure compliant submissions and product information across markets, steering timelines and regulatory strategy with internal teams and external partners.

The role requires 8–12 years of related experience, strong knowledge of EU/RoW frameworks, and expertise in MAA/NDA/ACTD submissions, with the

Qualifications

• Bachelor's degree in a scientific/health field is required.

Responsibilities

• Provides strategic and operational regulatory support to project management on new divestment projects, technical transfer, CMOs, quality assurance and commercial departments.
• Leads the preparation of core dossiers and submissions for global roll out.
• Authors, reviews and approves M1, M2 and M3 dossier sections and Product Information; M4/M5 drafting is an added advantage.
• Outlines global regulatory intelligence and strategy with global partners, consultancies and distributors.
• Reports on regulatory workload and ensures timely submissions in regulatory meetings.
• Interprets regulations for project teams and keeps them updated on regulatory changes, risks, and mitigations.
• Serves as primary contact to local health authorities and internal stakeholders for submissions.
• Facilitates communication between health authorities and project teams.
• Coordinates submission components from various functions, distributors and CMOs.
• Proactively identifies issues and supports mitigation plans.
• Attends cross-functional and kick-off meetings; mentors junior staff and regulatory team members.
• Maintains professional expertise through literature review and training.

Skills

Regulatory strategy

EU RoW knowledge

Regulatory submissions

MS Office

Education

Bachelor's degree in Science/Health field

Job description

Manager Regulatory Affairs | Mumbai/Vadodara| Hybrid

(Global Regulatory Affairs / EU / RoW Regulatory Framework/Regulatory Dossier & Submission Expertise - MAA, NDA, ACTD, CTD (M1-M3)

Lead regulatory activities to support the development, registration and ongoing maintenance of pharmaceutical products across relevant markets. The role will ensure regulatory submissions and product information are accurate, compliant and delivered to agreed timelines. Working closely with internal teams and external partners, the successful candidate will provide clear regulatory guidance, manage competing priorities and contribute to effective regulatory strategies.

Key Responsibilities

• Provides strategic and operational regulatory support to project management on new divestment projects, technical transfer, CMOs, quality assurance and commercial departments.
• Leads the preparation of core dossiers and submissions for global roll out.
• Authors, reviews and approves M1, M2 and M3 dossier sections as necessary, justification documents and Product Information. M4 and M5 authoring and drafting overviews would be an added advantage.
• In collaboration with global partners, consultancies and distributors, and with senior management outlines global regulatory intelligence and form a global regulatory strategy.
• Ensure diligent reporting and progress updates on regulatory workload at weekly/bi-weekly internal regulatory meeting
• Interprets applicable regulations and guidelines for project team use and keep team abreast of regulatory decisions, evolving regulatory requirements, risks and mitigation plans.
• Serves as a primary contact to the local health authority (HA(s), local consultancies/ distributors and internal stakeholders, to ensure timely and accurate submissions.
• Facilitates communication between the HA(s) and the project team.
• Coordinates and solicits components of the submission from various functional areas, distributors and CMOs.
• Proactively identifies project issues and supports mitigation plans.
• Attends cross functional meetings, CMO meetings and kick-off meetings as required.
• Mentors and/or manages other Regulatory Managers, Regulatory Associates and other junior level or administrative Regulatory staff.
• Maintains a high level of professional expertise through familiarity with scientific literature and participation in training courses.
• Responsibilities may include training employees; planning, assigning, and overseeing regulatory submissions

Qualifications

• Bachelor's degree is required. Scientific/health field.

Required Skills & Experience

• 8 to 12 years of related experience within a pharmaceutical company, CRO, CMO or similar organization. The regulatory experience should be broad as a "generalist" regulatory professional
• Strong knowledge of EU/RoW regulatory framework and guidelines.
• Awareness of emerging markets submission rollouts.
• Expertise in regulatory submission structure and content (e.g. MAA, NDA, ACTD)
• Experience in compliance and maintaining product life cycle data bases and RIMs systems
• Expertise to write technical and scientific documents.
• Must be able to communicate comfortably and effectively with regulatory authorities.
• Must be able to independently present complex global regulatory strategies internally and to Atnah's partners.
• Ability to work successfully within a cross-functional team.
• A proactive approach to problem-solving, continuous improvement and maintaining regulatory compliance.
• Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.
• Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands.
• Proven ability to independently resolve problems.
• Strong knowledge of MS Word, Excel, PowerPoint, Project and Outlook
• Global regulatory strategy and deployment decisions; defining strategic priorities
• Ability to work independently, take initiative and complete tasks to deadlines

What we offer (benefits & career development)

• Competitive salary and benefits package.
• Opportunities to develop regulatory expertise and contribute to the delivery and maintenance of pharmaceutical products.
• An inclusive workplace culture that supports collaboration, continuous learning and professional development.