30 days old

Reg Affairs Officer

San Jose, CA 95123
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+ Manage the development of regulatory strategies to support the registration of drug products, line extensions, major variations and lifecycle management.

+ Maintain licenses (e.g. Marketing Authorizations) in compliance with local regulations by ensuring that corporate regulatory processes, SOPs and systems (e.g. CMC change control, product labelling, etc.) are in place.

+ Manage the completion of NDA and Lifecycle (LC) submissions and approvals as per established performance metrics and Alliance Partner model.

+ Responsible for ensuring that all regulatory activities (new product submissions, existing licenses, etc.) are compliant with local regulations, requirements and practices.

+ Provide input to the relevant stakeholders for the development of products in-line with business objectives, ensuring strategies are adequately reflected in relevant country plans (e.g., business development or manufacturing supply) and alignment is achieved between regulatory activities and relevant country business/commercial plans.

+ Provide consultative and intelligence support to internal stakeholders. Advise where necessary, on the development of responses to regulatory queries, including coordination on the receipt, distribution and response to regulatory queries on assigned projects, consistent with departmental procedures.

+ Develop strong partnerships with in-country and and above-country colleagues to facilitate the development and implementation of registration strategies to expedite the registration of new products, line extensions and life-cycle optimization.

+ Provide strategic contribution to the RA leadership.

+ Contribute to change management and continuous improvement projects (Regulatory Operational Excellence).

+ Responsible for developing and supporting relationships with key external agencies. Support the Health Authority interface throughout the development and lifecycle of a product. Support long-term and positive relationship characterized by integrity, quality, compliance and leadership. Facilitate meetings and participate in negotiations with regulatory authority as necessary.

+ Active participation in trade associations and effective communication to key stakeholders of key issues that could impact regulatory strategies or the business. Understand regional regulations and developing trends in the local regulatory environment and provide assessment of the impact to key stakeholders. Leverage regulatory intelligence/landscape knowledge to support the development and implementation of regulatory and business.

+ Responsible for the development, leadership and performance management of direct reports (where applicable) to achieve company objectives. Develop and enhance the capabilities and capacities of the direct reports (where applicable) through the identification and implementation of training and development needs.

**Project Management:**

+ Oversee and/or facilitate strategic process improvements initiatives.

+ Ensure product strategies, submission and approval time lines.

**People Management (where applicable):**

+ Foster continual learning to promote regulatory excellence.

+ Manage the performance of direct reports to achieve agreed objectives.

+ Identify and address training and developments needs to encourage and talent development and succession planning.

+ Keep team continuously engaged to retain/attract talent.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Posted: 2019-05-21 Expires: 2019-06-21

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Reg Affairs Officer

San Jose, CA 95123

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