Regulatory Affairs Director

4 weeks ago

Florham Park, New Jersey, United States Shionogi Inc. Full time
Job Summary

We are seeking a highly skilled Regulatory Affairs Director to join our team at Shionogi Inc. This role will provide essential support to the Executive Director in overseeing regulatory activities related to antiviral initiatives on a regional and/or global scale.

Key Responsibilities
  • Develop and execute regional regulatory strategies for antiviral initiatives within specific regions.
  • Provide strategic oversight and leadership to the regulatory team, ensuring alignment with company objectives and regional regulatory requirements.
  • Contribute to the preparation and submission of regulatory documents related to antiviral initiatives to regulatory authorities.
  • Collaborate with cross-functional teams to integrate antiviral considerations into product development, manufacturing, and commercialization processes.
  • Foster relationships with regional regulatory authorities to facilitate communication, negotiations, and interactions related to antiviral initiatives.
  • Monitor regulatory developments, changes, and trends within specific regions, and provide insights to the Senior Director.
  • Manage regulatory risks and opportunities related to antiviral initiatives and contribute to developing mitigation strategies as needed.
  • Provide regulatory guidance and support for post-marketing activities related to antiviral initiatives, including variations, renewals, labeling updates, and compliance initiatives.
  • Represent the company's interests in industry forums, working groups, and regulatory meetings related to antiviral initiatives.
  • Support the Senior Director in serving as a subject matter expert on regional regulatory requirements, guidelines, and best practices related to antiviral initiatives.
  • Coordinate with global regulatory counterparts to ensure alignment of regional regulatory strategies and submissions with global development plans and corporate objectives.
  • Prepare regulatory updates, progress reports, and strategic recommendations to senior and/or executive leadership and regulatory governance committees.
Requirements
  • Bachelor's degree in a scientific discipline such as life sciences, pharmacy, bioscience; advanced degree preferred.
  • 7+ years of experience in regulatory affairs within the pharmaceutical or biotech industry, with a focus on antiviral products preferred.
  • Demonstrated ability to work effectively in a cross-functional team environment.
  • Strong knowledge of regional regulatory requirements and guidelines, including FDA regulations and ICH guidelines.
  • Excellent communication and interpersonal skills.
Competencies
  • Ability to assist in developing and executing regulatory strategies tailored to specific regions.
  • Strong organizational skills with attention to detail.
  • Ability to collaborate effectively with cross-functional teams.
  • Knowledge of regulatory submissions and documentation processes.
  • Awareness of regulatory developments and trends within specific regions.
  • Strong analytical and problem-solving skills.
  • Ability to work independently and prioritize tasks effectively.
Other Requirements
  • This position has some decision-making authority.
  • Ability and willingness to travel approximately 10% of the year both domestically and internationally.
  • Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Office presence required at least 50% of the time per month.
Essential Physical and Mental Requirements
  • Ability to articulate clearly and conduct verbal presentations with large and small audiences.
  • Ability to travel via automobile and/or airplane.
  • Ability to view video display terminal images < 18 away from face for extended period of time - up to four (4) hours at a time.
  • Ability to operate a computer keyboard and telephone.
  • Ability to sit for extended periods of time - up to four (4) hours at a time.
  • Ability to lift, tug, pull up to fifteen (15) pounds.

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