Associate Director / Director of Regulatory Affairs - Global Development Products (Anti-Viral) Job at Planet Pharma, Florham Park, NJ

ZzVkTmVWM1FrdUxHazhmRjVra1R0SFRac3c9PQ==
  • Planet Pharma
  • Florham Park, NJ

Job Description

We are looking for Full Time Permanent candidates and also have full-time consulting opportunities with our client in NJ. No third party inquiries please. Must be able to work onsite 50%.

The Associate Director/Director, Regulatory Affairs - Global Development Products (Anti-Viral), 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.

Detailed Description:

  • 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.
  • Bachelor's degree in a scientific discipline such as life sciences, pharmacy, bioscience; advanced degree preferred.
  • 7+ years (Associate Director)/ 10+ years (Director) 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.
  • 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.
  • 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 NJ. Office presence required at least 50% of the time per month

Job Tags

Permanent employment, Full time,

Similar Jobs

HirefinderRPO

Truck Driver Job at HirefinderRPO

 ...re seeking a highly skilled and safety-conscious Class A Truck Driver to join our team. If you're a seasoned professional with a passion...  ...vital equipment across Colorado, ensuring timely and secure deliveries. Responsibilities: Driving and Operating: Safely drive... 

Audi Hawthorne

Valet Job at Audi Hawthorne

At New Country, our people do whatever it takes to find solutions. Were building a culture thats genuinely engaged & dedicated to communities we serve. Our dealerships & employees pride themselves on being deeply involved in local communities, charities, nonprofit organization...

Illuminate ABA Therapy

Board Certified Behavior Analyst Job at Illuminate ABA Therapy

 ...quality developmental therapy services to neurodiverse children and teens across multiple states in the US. At Illuminate, there is...  ...insurance ~ Dental insurance ~ Vision insurance ~401K ~ Flexible Spending Account (FSA)~ Health Savings Account (HSA)~ Generous... 

Trident Consulting

Salesforce Administrator Job at Trident Consulting

 ...Administrator in Concord, CA Hybrid Onsite . Please read further about the job profile: Role: Salesforce Administrator - CPQ & CRM Location: Concord, CA ( Hybrid Onsite ) Duration: Contract to hire (W2 Contract) Job Summary: We are seeking an experienced... 

Cook Systems

Senior Magento Developer Job at Cook Systems

 ...COOK SYSTEMS INTERNATIONAL has an IMMEDIATE need for a Senior Magento Developer (100% remote contract) This project will focus on enhancing our Magento platform to address key gaps in order management, payment processing, integration with Authorize.net, and backend...