Apeksha Shinde
Location
Navi Mumbai | India
Job description
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 essentialJob tags
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