Manager, Regional Regulatory Strategist Sterile Injectables

Represent a particular region for regulatory affairs (US, EU or EM).

Provide regional strategic expertise to relevant forums (i.e., to the GMT, Global Regulatory Strategic Team (GRST), etc.).

Lead and implement regional regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the commercial goals.

Be accountable for timely submissions and approvals with commercially attractive labelling in the designated region.

Be accountable as the main point of contact with Health Authorities in relation to the assigned project(s) within designated region.

Role can be combined with other Regulatory Role(s) (i.e., Global Regulatory Lead).

Provide operational support of activities as assigned (i.e., researching regulatory background for products in scope).

Accountable for ensuring regional (US, EU or EM) contribution to Global Regulatory Strategies and implementation plans (including core labels and risk registers) for assigned projects.

Ensures regulatory contributions achieve the objectives in the strategy, to agreed standards, maximizing overall project delivery time and probability of success and facilitating post filing activities.

Partners with project teams and other customer groups (e.g., RU/BU, Regional Commercial Teams) to ensure required regulatory contributions (line plans, label, CTA, MAA/IRD, variations, license renewals, etc.) meet business needs and are provided to the project teams, to agreed time and quality standards.

Ensures regulatory plans are monitored, progress/variance is communicated to GRL and Senior Management and any risks (from emerging technical data, changing internal objectives or external threats) are mitigated.

Ensures an aligned regional regulatory position is reached and communicated for all key issues for assigned project/s, and that these regulatory positions supporting the regional business are championed and communicated.

Engages in appropriate activities to influence the regional regulatory environment through GRS-In Country colleagues, Agency contacts and/or Trade Associations as appropriate.

Ensures business compliance and implementation of and adherence to Regulatory standards.

Develops and maintains, directly or indirectly, constructive working relationships with Health Authority contacts in the assigned region.

Maintenance of information in regulatory systems and support of regulatory systems incl.

data analysis and mining.

Support of operational activities as assigned including coordination of submissions, responses to regulatory queries, labeling activities, market requirements management, and other regulatory tasks.

Support creation and maintenance of documents like internal trackers and submission documents incl.

QC and gap analysis.

Provide regular updates on work progress, highlighting any critical developments or emerging risks that may impact outcomes or require leadership attention.

Proven experience in managing national and/or regional regulatory process and registration aspects of the drug development process and/or post-approval study requirements.

Previous experience as a national and/or regional regulatory liaison for at least one product in different therapeutic areas, familiarity with generic/non-innovative registrations and in different stages of the product life cycle is highly desirable.

Equivalent experience, either at a regulatory agency or working on substantive industry-government collaborations, can be considered.

Experience in communicating with FDA or major EU regulatory agency(ies) for US and EU regulatory strategists respectively, as well as participating in/leading such interactions, is preferred.

Knowledge of drug development practice rules, regulations and guidelines:

Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines.

Proven ability in developing and implementing regulatory strategy

Understanding of regulatory agency philosophy and guidelines.

Experience preparing and submitting INDs and/or CTAs, NDAs / MAA/IRDs. Working with and influencing regulators and opinion leaders, facilitating approval of submissions with labeling meeting corporate expectations.

Ability to communicate complex information and analyses to diverse scientific audiences, both verbally and in writing, with fluency in English.

Highly proficient in conveying strategic and tactical issues to management, and skilled at identifying and escalating risks and unique or complex submissions through appropriate channels.

Ability to negotiate skillfully in tough situations with both internal and external groups.

Can be direct and forceful as well as diplomatic.

Gains trust quickly of other parties to the negotiations.

Provide the primary groups or key role(s) that this role will interact with as a regular part of the Job responsibilities.

Include any external interactions as appropriate.

Works with PRD/GRS colleagues and relevant project team(s) across functions (i.e. Clinical, Development, Medical, Safety and Risk Management, Pharmaceutical Sciences, Global Supply, Legal, etc.).

Partners with regional colleagues, including GRS-in Country colleagues, Medical and Commercial colleagues, to provide a regional position.

Works directly or indirectly with external contacts in Regulatory Agencies within assigned region, as well as relevant experts.

Dependent on level