Regulatory Affairs Manager

**Basic Functions & Responsibility (may not be limited to)**:

- For assigned products ensures timely, accurate and compliant labelling translations and artwork preparation.
- Supports the agency interactions to ensure a seamless submission, assessment, and quick approval of CMC variations, non-CMC variations, renewals, OMA, according to the Mexican Regulation, in cooperation with RAI Liaison, iCMC and other internal stakeholders as applicable.
- For assigned products and tasks, stays updated on late our company pipeline filings, relevant local regulations, and guidelines and to develop and maintain positive relationship with key players in the regulatory environment. Designs and implements regulatory ad-hoc local action plans, as necessary.
- Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
- For assigned products and tasks, works alongside the BD, locally and regionally to support business initiatives in sub region.
- Maintains a positive relationship with internal and external regulatory contacts. GRACS on regional and global level

External contacts are regulatory authorities, as well as other key players in the regulatory environment such as Trade Associations.
- By discretion of Regulatory Affairs Management and due to organization and workload, all listed activities need not to be performed.
- Responsible for people management of applicable Regulatory personnel in Country and provides clear leadership for these. Secures appropriate career development for the applicable staff and is responsible for keeping the applicable staff scientifically and legally updated within the Regulatory area.
- Acts as substitute for Country Lead Regulatory Affairs as appropriate.

**Major Activities (may not be limited to)**:

- Manages answers to objections from the Agency on products registration and major new indications, involving negotiations to achieve best conditions.
- Designs and implements local action plans for new products, involving selection and regulatory training of external experts and closely interacting with the Agency.

**Maintenance of licenses for assigned products**:

- Ensures that marketing authorizations are maintained in compliance with related regulatory areas, through performing the necessary activities, including variations and renewals, with a high standard and within the agreed timeframes and communicates approvals to stakeholders through the correct processes.

**Compliance**
- For assigned products, ensures timely preparation and Patient Package Inserts, local physicians' circulars, packaging material and other applicable regulatory documents according to our company and local standards and Artwork Management procedures. Implement Prescribing Information within the correct timeframes for compliance.
- Ensures that all internal customers receive relevant information regarding the regulatory status of the assigned products.
- Ensures the correct and proper utilization of Artwork Management System to generate artworks. - Ensures efficient and consistent implementation and use of internal and external regulatory databases and systems in the country.
- Ensures that files and archives related to Regulatory are kept updated and complete.
- Participates in establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations are complied with.
- Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.

**Labelling and artwork**
- Ensures high quality translations and QRD check of Patient Package Leaflets including linguistic check of these documents.
- Ensures availability of packaging material, including package leaflets and all other artwork in a timely and correct manner and according to relevant Artwork Management procedures.

**Cross-functional activities**
- Provides regulatory guidance and support to the license companies/joint venture/co-marketing partners as appropriate.
- Secures timely and adequate information and decision making in regards to regulatory issues that need to be brought to the attention of the Management Team, such as deletions, divestitures and acquisitions.
- Takes part in subsidiary product and launch teams to provide regulatory input and strategy advice.

**Regulatory Policy & Environment**
- Keeps abreast of local and international laws, collects relevant publicly available regulatory information, provides insights, and responds to consultations on proposed national regulatory guidance, as appropriate, and communicates final regulatory guidance for awareness and impact assessment, in cooperation with Global Regulatory Policy.
- Advocates for therapeutic areas/local positions on regulatory issues and trends internally (cross-functional internal business partners including PV, market access, policy etc.), and externally (Agency, Industry Association) contributing to a broader