Job Description :

- Accountable for the development and implementation of regulatory strategies in the International Markets (IM) region. 

- Lead, implement and drive the regional RA strategy & submission activities, including the planning, coordination and submission of Briefing Packages, meeting requests, CTAs, MAAs, variations and other regulatory filings to ensure compliance with local regulatory standards.

- Together with the local RA teams, develop effective proactive regulatory strategies for development and marketed products. Recommend such strategies to team members and Senior management.

- Ensure that cross-functional activities to support submissions are in compliance with regulatory requirements, to achieve timely submissions. 

- Identify gaps and propose/support solutions to address them that are consistent with regulatory requirements. 

- Initiation and/or participation in teleconferences and/or meetings related to the topic/project under lead (to clarify issues, solve issues, discuss changes and strategy, check timelines and availability of documents, etc).

- Coordinate and lead the team in planning, preparation, and execution for meetings or teleconferences with Health Authoritis, as needed, author the Briefing books to support such meetings.

- Coordinate responses to Health Authorities with appropriate personnel and departments to resolve outstanding regulatory issues.

- Work with the cross functional global team to provide input into product development strategy and ensure appropriate share of voice for International Markets in the global team.

- Work closely with commercial functions to devise appropriate regulatory strategies to support commercial needs.

- Work with appropriate stakeholders to design and support appropriate lifecycle management strategies to support the business needs of the International Markets.

- Review and assess the change controls for the product under his/her responsibility to establish the regulatory impact and define the strategy for the implementation of the changes in the relevant markets.

- Assessment of business development opportunities from an IM regulatory perspective

- Manage and review the work of IM regulatory affairs staff. 

- Mentor and develop staff to ensure implementation of corporate goals and objectives.

- Other duties as assigned or as business needs require.

- Bachelor's degree in a scientific discipline, such as Biology, Chemistry, Pharmacy, or related fields. 

- Advanced degree (Master's or Ph.D.) is advantage

- 10+ years of experience in regulatory affairs, with exposure to early development as well as lifecycle management (or equivalent combination of regulatory and related work experience)

- Familiarity with CTD format and ICH requirements for registration of pharmaceuticals/biologics/devices

- Ideally, some understanding of regulatory landscape in International markets (specially China and Japan).

- Good understanding of medicinal product development - Both small molecules as well as Biologics.

- Ability to strategically apply knowledge across a protfolio of products.

- Experience with preparing and reviewing regulatory submissions (e.g., IND, NDA, BLA, MAA).

- Ability and experience of authoring regulatory documents like briefing books etc

- Business savvy. 

- Ability to work with the business.

- Good leadership project management and managerial capability

- Excellent analytical, problem-solving, and communication skills.

- Ability to work effectively in a cross-functional team environment and manage multiple projects simultaneously.

- Detail-oriented with a high level of accuracy in work deliverables.

- Strong organizational and time management skills.

- Excellent spoken and written English is essential

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