AD/Director Regulatory Affairs, GDP

1 month ago

florham park, United States Planet Pharma Full time

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

1 year contract with potential to extend


Overview:

The Associate Director, Regulatory Affairs – GDP Contractor, provides essential support to the Executive Director 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. The Associate Director will work closely with cross-functional teams to integrate antiviral considerations into product development, manufacturing, and commercialization processes. This position plays a pivotal role in ensuring alignment with company goals, regional requirements, and best practices to achieve successful outcomes for our antiviral initiatives.


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.

Other duties as assigned.


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.


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


compensation/title within this range will be commensurate with level of experience

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