Regional Regulatory Hub Strategist

Proclinical is seeking a Regional Regulatory Hub Strategist. The primary focus of this role is to support regulatory CMC submissions with a focus on lifecycle, ensuring compliance with local regulations and requirements for assigned markets. This includes managing health authority queries and ensuring transparency and excellence in the evaluation, definition, and execution of regulatory strategies. The role also involves proactive relationship building across functions and clear communication of regulatory timelines and strategies.

Key Responsibilities

• Support regulatory CMC submissions for assigned markets.
• Ensure compliance with local regulations and requirements.
• Manage health authority queries.
• Define and execute regulatory strategies.
• Build cross-functional relationships and communicate regulatory timelines and strategies.
• Ensure dossiers are produced and dispatched according to the defined filing plan.
• Manage regulatory activities for defined markets and resolve issues in a timely manner.
• Collaborate with key partner lines to enable post-approval strategy and execution.
• Author local submission components as needed.
• Coordinate the receipt, distribution, and response to regulatory queries.
• Maintain and update regulatory requirements in the appropriate system.
• Cultivate positive and professional relationships both internally and externally.

Requirements

• Bachelor's degree or equivalent in Chemistry, Pharmacy, or a related life science.
• Prior experience in Regulatory Affairs, Conformance, or Compliance in the pharmaceutical or related industry.
• Knowledge of IDM regulatory procedures and requirements.
• Proactive and forward-looking mindset.
• Good knowledge of the IDM regulatory environment.
• Ability to understand CMC submissions, interpret and communicate BoH requirements, and identify potential regulatory risks.
• Knowledge of drug development practice, rules, regulations, and guidelines.
• Strategic and analytical thinking.
• Excellent communication skills.
• Teamwork and collaboration skills.
• Strong quality and compliance orientation.
• Change agility.
• Fluency in English.

If you are having difficulty in applying or if you have any questions, please contact Elise Stewart at e.stewart@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.