Regulatory Affairs Director

1 day ago

Florham Park, New Jersey, United States Planet Pharma Full time
Job Title: Associate Director, Regulatory Affairs - GDP Contractor

Florham Park, NJ - Onsite 2-3x a week

1-year contract with potential to extend

Job Summary:

The Associate Director, Regulatory Affairs - GDP Contractor, plays a pivotal role in overseeing regulatory activities related to antiviral initiatives on a regional and/or global scale. This role involves assisting in the development and execution of regulatory strategies, regulatory submissions, and fostering collaboration with regional regulatory authorities.

Key Responsibilities:

  • Support the Executive Director in developing and executing regional regulatory strategies for antiviral initiatives within specific regions.
  • Assist in providing 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.
  • Assist in fostering relationships with regional regulatory authorities to facilitate communication, negotiations, and interactions related to antiviral initiatives.
  • Support in monitoring regulatory developments, changes, and trends within specific regions, and provide insights to the Senior Director.
  • Assist in managing 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.
  • Collaborate with the regulatory team to 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.
  • Assist in coordinating with global regulatory counterparts to ensure alignment of regional regulatory strategies and submissions with global development plans and corporate objectives.
  • Assist in preparing regulatory updates, progress reports, and strategic recommendations to senior and/or executive leadership and regulatory governance committees.

Qualifications:

  • 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.

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.
  • Compensation/title within this range will be commensurate with level of experience.

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