The VP, US Regulatory Affairs is responsible for setting, driving, and executing all regulatory activities including the development, implementation, and management of US regulatory strategies; regulatory submissions and regulatory affairs support teams; handling interactions with regulatory agencies, maintaining compliance, and keeping current with changes in the regulations for our products. Additionally, the VP, US Regulatory Affairs works closely with other departments to ensure that the organization’s products and activities meet regulatory requirements with the end goal of bringing products to market in a timely and compliant manner while minimizing risk. This role is a member of the senior leadership team.
Responsibilities
The following list provides an overview of the key responsibilities, it is not mean to be an exhaustive list:
• As contributing member of Senior Leadership Team and possibly other committees, attends on-site meetings and collaborates with the SLT to set and execute US company’s strategy, allocating resources, building culture, developing key client relationships, fostering collaboration and alignment across departments, representing the company, and driving the companies’ initiatives and vision.
• Develops, drives, and executes US regulatory strategies that align to the business objectives by creating plans that meet regulatory requirements, anticipating changes in regulations, building relationships with regulatory agencies, managing regulatory submissions, minimizing risk, and collaborating with other departments to ensure that all activities are in compliance with regulations for products pre- and post-approval.
• Communicates regulatory strategy to all stakeholders, including regulatory professionals, senior management, R&D, quality, commercial, and regulatory agencies, to ensure that everyone is aligned to the strategy.
• Monitors progress of strategy and adjusts the strategy based on business priorities.
• Prioritizes regulatory activities based on company objectives ensuring most critical regulatory tasks are of primary focus.
• Stays abreast of regulatory changes and developments that may impact the company’s products.
• Develops and maintains strong relationships with key stakeholders, including regulatory agencies, industry associations and advocacy groups.
• Provides expert regulatory guidance and support to internal teams, including legal, quality, commercial, R&D and others.
• Provides leadership and direction to the US RA-GDP function, ensuring the organization follows regulatory standards and that the products are brought to market in a timely manner. Manages and oversees the US RA-GDP team, ensuring that the right people are in the right roles and has the appropriate resources needed to be successful.
• Other duties as assigned.
Supervisory | Decision-Making Authority Leads and oversees the RA-GDP teams and has decision-making authority for the U.S. functions listed above.
Minimum Job Requirements
• Master’s Degree or Doctoral Degree in regulatory affairs, public health, or life-sciences related degree. Regulatory affairs certification such as RAPS is desirable.
• At least 12-15 years of experience in regulatory affairs in the pharmaceutical industry, with a proven track record of securing regulatory approval for pharmaceutical products.
• In-depth knowledge of regulatory requirements, including FDA regulations and guidelines, and experience in managing complex regulatory projects.
• Commitment to staying abreast of regulatory changes and developments, and to ensuring compliance with all relevant regulations.
• Excellent communication, leadership, and interpersonal skills, with the ability to effectively collaborate with cross-functional teams, regulatory agencies, stakeholders, and senior leaders.
• Strong analytical and problem-solving skills, with the ability to assess regulatory risks, make informed decisions, and develop effective strategies.
• Ability to manage a team of regulatory affairs professionals and motivate them to achieve shared and individual goals.
• Excellent organizational and project management skills, with the ability to manage multiple projects and meet deadlines.
• Excellent organizational and project management skills, with the ability to manage multiple projects and meet deadlines.
• Capable of establishing relationships with regulatory professionals, internal and external stakeholders such regulatory agencies, industry associations, and advocacy groups.
• Ability to adapt to changing circumstances and a willingness to travel, as necessary, to engage with regulatory agencies and other stakeholders.
• Willingness and ability to travel, as necessary, to engage with regulatory agencies and other stakeholders.
qualified candidates should email CV and Cover Letter to jobs@tseworldwide.com