Associate Director-regulatory Scientist, Global Regulatory Affairs-asia Pacific

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

**Associate Director/Director, GRA-EMEA,**GRA-Asia Pacific** or GRA-Americas Regional Regulatory Scientist**

**Purpose**:
The Associate Director/Director, Global Regulatory Affairs (GRA)-EMEA, GRA-Asia Pacific or GRA-Americas Regional Regulatory Scientist is accountable to establish the local regulatory strategy and plan for assigned product(s) in region/country, ensure local plan aligns to the global regulatory strategy (i.e. RSD) and ensure local regulations and region/country business needs are included.

The Associate Director/Director, Global Regulatory Affairs (GRA)-EMEA, GRA-AP or GRA-Americas Regional Regulatory Scientist is accountable to provide regional regulatory expertise in delivering high quality and efficient regulatory submissions, approvals, and local labelling for their assigned product(s). The Associate Director/Director is responsible for leading meetings and other interactions with region/country regulators.

The Associate Director/Executive Director, Global Regulatory Affairs (GRA)-EMEA, GRA-AP or GRA-Americas Regional Regulatory Scientist may perform regulatory evaluations of external business opportunities, as requested by management, and may effectively manage alliance/CRO relationships in regulatory area.

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

**Regulatory Expertise for Assigned Program/Product(s) in Region/Country**
- Provide region/country input and review of global strategic plans and global/regional submission plan and documents.
- Contribute during key governance committees on regional regulatory strategy decisions, if requested (e.g. when key discussion topics impact the region).
- Ensure approval and delivery of content for local regulatory submissions, engaging cross functional partners in contributing to development of submission content.
- Own relationship and lead meetings and interactions with regulators in assigned region and engage cross functional partners to contribute to regulator interactions. Influence the regulator in favor of the planned development.
- Ensure compliance with all applicable regulations and internal quality systems.
- Provide up-to-date expertise on regional registration procedures.
- Interpret and anticipate impact of new guidelines and initiate change in response to changing environment.
- Own all regulatory activities in support of assigned marketed product(s) in the region/country.

For regional regulatory scientist supporting the US:

- Set appropriate direction with Global Marketing and US Brand Team for development, review, and approval of promotional claims.
- Partner with GRA-Product Communications reviewer to advise US Brand Team on promotional strategy

For regional regulatory scientist supporting Asia Pacific
- Ensure the local regulatory requirements in AP countries are communicated to development and CMC teams for incorporation into molecule development programs
- Ensure the registration needs for local patients in clinical trials are met for countries in the region/country

For regional regulatory scientist supporting for EMEA:

- Be involved in medical device/in-vitro diagnostics regulatory activities and to potentially serve as, or perform the responsibilities of, the medical device UK Responsible Person or EU Authorized Representative in accordance with applicable UK or EU legislation, respectively, and the associated internal Quality Agreement(s).
- Ensure the registration needs for local patients in clinical trials are met for countries in the region/country

**Lead, influence and partner**
- Partner with Global Regulatory Leads to help solve development and regulatory issues impacting local registrations and when engaging with relevant business unit and development team on assigned programs/products.
- Partner with Global Regulatory Leads to ensure a robust regulatory and submission sequencing strategy is developed, endorsed, and executed for countries in assigned region.
- Liaise with the affiliates to anticipate region/country specific issues, impact of labelling on promotion, pricing, and reimbu