Role Overview
The Vice President of Regulatory Strategy is responsible for providing regulatory leadership and for the planning and oversight of all regulatory submissions from pre submission to approval.
Responsible for addressing data requirements to regulatory authorities. This position will provide regulatory and technical expertise across the development of its product candidates. Prepares for and expedites early and effective approval of pharmaceutical new products in accordance with regulatory strategy. They will work cross-functionally with R&D, quality, clinical operations, medical affairs/ pharmacovigilance, supply chain, compliance, legal, operations, and sales/marketing.
This position leads and coordinate IP activities (PIV and other) with the Corporate Legal team ensuring compliance to the allocated budget and overall business strategy. From a Technical Services capacity they will lead the initiatives with internal Manufacturing and QA teams in Spain and India, on approved and launched products. This will include collaboration and strategy on scale-up/validation, process efficiency and any troubleshooting activities. They will collaborate with Supply Chain as needed from a technical perspective on internal commercially launched products.
Primary Duties & Responsibilities
Leadership and Management:
Lead and manage the regulatory affairs team, providing guidance, training, and development opportunities.
Collaborate with other departments, including R&D, Quality Assurance, and Manufacturing, to ensure regulatory compliance throughout the product lifecycle.
Serve as the main contact point in the US for the FDA and will also be responsible for the development and implementation of all regulatory strategies.
Develop and mentor the local and global regulatory affairs staff on current FDA thinking and expectations as well as emerging US regulatory landscape.
Oversee and direct regulatory staff (direct reports). Assign and manage regulatory staff workload.
Regulatory Strategy:
Develop and implement regulatory strategies to ensure compliance with FDA and other regulatory bodies.
Oversee the preparation, review, and submission of regulatory documents, including ANDAs, NDAs, and supplements.
Maintain an up-to-date knowledge of all applicable FDA regulations and laws and undertake training and/or information sharing with colleagues to ensure new regulations/guidances are implemented appropriately
Contribute to the creation of the overall product development strategy and manage the development, monitoring and delivery of Regulatory project plans throughout the life cycle
In-depth understanding of the drug development, product commercialization and life cycle management processes to inform regulatory strategy
Familiarity with Chemistry, Manufacturing, and Control (CMC), Pharmacovigilance and Quality, related matters, and their intersection with Regulatory Affairs Regulatory Submissions and Documentation:
Ensure timely and accurate submission of regulatory reports to relevant authorities.
Maintain records in a central repository, including proposals, presentation materials, contracts, and documentation that the outputs were captured and used internally.
Ensure all records, information, and deliverables related to the annual reporting procedure are retained as required by applicable law, contract, or regulatory requirement.
Critically review all regulatory submissions prior to filing ensuring application quality. Dependent on the criticality of the submission this function may be delegated to the responsible regulatory affairs manager.
Compile and review ANDAs and 505b2 applications for both internally and externally developed and managed product portfolios.
Product and Business Initiatives:
Partner with Portfolio and Business Development team to research and advise on new products and business initiatives.
Maintain ongoing subject matter expertise in relevant laws to support business objectives.
Develop regulatory timelines and budget forecasts and be accountable for tracking and delivering accordingly on all internal and external development projects. This includes working with Global R&D and other functions on budgets for R&D Spend, Legal Spend, Partner Milestone Spend, and Regulatory Spend.
Manage overall legal (PIV) spending and direct legal strategy in alignment with business needs.
Provide technical oversight of scale-up and validation of internally manufactured products.
Support Supply Chain to ensure continuity of supply.
Oversee departmental workflow procedures as they relate to regulatory compliance and ensure the company is up to date regarding state/federal regulations and compliance obligations.
Additional Duties & Responsibilities
Excellent communicator and problem solver with the ability to influence at the Executive and Board level and experience working with FDA Divisional Heads & Regulatory Project Managers.
Serve as the US Agent for key business partners and business units as necessary to support US business ventures.
Support the organizations business development objectives by assisting and providing potential product targets, conducting or managing regulatory due diligence.
Competencies/Career level
Please list all that apply: Innovation, entrepreneurial attitude, customer orientation, team leadership, adaptability/flexibility, results-oriented, control of budgets/costs, Self-development.
Requirements and personal skills
Education: Bachelors Required, Graduate education preferred
Languages: English
Experience (years/area): Minimum of 15 years of executive leadership experience in regulatory affairs, regulatory compliance, or pharmaceutical regulatory strategy, with a proven track record in the generic drug industry.
Personal skills: General management skills, strong interpersonal and people development skills, strong results-orientation, superior leadership skills, and ability to anticipate problems and solve them successfully.