Manager Regulatory Affairs

Location

Mumbai | India

Job description

Reporting to the Senior Manager, Regulatory Affairs, you will be a key member of the team which is responsible for providing strategic and operational regulatory support to project management on new divestment projects, technical transfer, CMOs, quality assurance and commercial departments.

Our Regulatory Affairs Department has an ethos of continuous improvement, refining systems and creating efficiencies. This, along with the rapid growth of the business, leads to a varied and dynamic working environment.

• Leads the preparation of core dossiers and submissions for global roll out

• Compile submission documents including M3 dossier sections as necessary, justification documents and Product Information.

• In collaboration with global partners, consultancies, and distributors, outline global regulatory intelligence and form a global regulatory strategy

• In collaboration with senior management and project strategy teams, develop and review global cross functional regulatory strategies

• Ensure diligent reporting and progress updates on regulatory workload at weekly/bi-weekly internal regulatory meeting

• Interpret applicable regulations and guidelines for project team use; keep project team abreast of regulatory decisions, evolving regulatory requirements, risks and mitigation plans

• Serve as a primary contact to the local health authority (HA(s), local consultancies/ distributors and internal stakeholders, to ensure timely and accurate submissions

• Facilitate communication between the HA(s) and the project team; attend and generally lead agency meetings, if required

• Coordinate and solicit components of the submission from various functional areas, distributors and CMOs

• Proactively identify project issues to the project team and support mitigation plans

• Attend cross functional meetings, vendor meetings and kick-off meetings as required

• Mentor and/or manage other Regulatory Managers, Regulatory Associates and other junior level or administrative Regulatory staff

• Maintain a high level of professional expertise through familiarity with scientific literature and participation in training courses

• Other responsibilities may include training employees; planning, assigning, and overseeing regulatory submissions

Candidates with at least 7 years of regulatory generalist experience within a pharmaceutical company, CRO, CMO, or similar organisation, and strong experience in new MAA applications, are likely to have the skills required to be successful in this role. We are also looking for:

• Bachelor s degree in science/health discipline

• Great IT skills including MS Word, Excel, Project, PowerPoint, and Outlook

• Expertise in regulatory submission structure and content (e.g., MAA, NDA)

• Experience in new MAA applications specifically in EU market experience in RoW market would be an added advantage

• Expertise in artwork requirements and review in line with regulations

• Strong knowledge of EU regulatory framework and guidelines

• Experience in compliance and maintaining product life cycle databases and RIMs systems

• Ability to effectively communicate with regulatory authorities

• Ability to independently present complex regulatory strategies with internal stakeholders and partners

• Awareness of emerging markets submission rollouts

• Expertise in writing scientific and technical documents, and strong attention to detail with proofreading materials

• Excellent time management skills with demonstrated ability to juggle multiple competing tasks and demands

• Strong organisational skills to establish priorities including scheduling and meeting deadlines

• Ability to work successfully within cross-functional teams

• Excellent professional communication skills, both written and verbal

• Fluent English language (written and verbal) is required, and another language, especially Italian or French, would be an ad

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