Prepare and deliver regulatory operational plans for assigned projects/products within a specific region. Provide strategic and operational regulatory input and guidance in cross-functional teams. Manage quality regulatory submissions to agreed project targets. Work flexibly within and across regions to provide broad operational support to ensure the delivery of product team and business objectives.
- Support the Global Regulatory Leader (GRL) for the delivery of timely approvals and product information in keeping with the needs identified by the business and markets and in compliance with relevant company procedures and regional/local country regulations.
- Lead the planning, preparation and delivery of both simple and complex submissions throughout the product’s life cycle from either a global and/or regional perspective.
- Liaise proactively with the functions and participate as a member of cross-functional delivery teams for complex submissions, providing regulatory advice
- Identify potential regulatory risks to the operational plan, and propose options to mitigate risks.
- Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents
- Assume assigned responsibilities for routine and non-routine contact with health authorities and affiliates to support the GRL.
- Maintain awareness of competitors’ activities and share potential impact these activities may have on the product development program
- Delivers project assignments supporting the business e.g. representation on functional workstreams
- Ensure that appropriate, up-to-date records are maintained for compliance
- Assist in development of regulatory standards and SOPs
- Provide input into Regulatory Strategy Plans and project budget as delegated by GRL
- Assist in due diligence activities for in-licensing opportunities
- A number of years’ pharmaceutical experience with knowledge of assigned regional regulatory procedures and legislation
- A Bachelors degree in a related field as a minimum
- Proven experience in building effective partnerships – identifying opportunities and taking actions to build effective relationships within the team and other areas. Influencing skills - through well thought through rationale and effective communication skills, able to influence key decisions
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