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REMOTE Sr. Regulatory Affairs Specialist

North Haven, CT 06473

Posted: 01/15/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 586218 Is job remote?: Yes Country: United States

Job Description

Responsibilities may include the following and other duties may be assigned.
  • Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company internal audits and inspections.
  • Leads or compiles all materials required in submissions license renewal and annual registrations.
  • Recommends changes for labeling manufacturing marketing and clinical protocol for regulatory compliance.
  • Monitors and improves tracking / control systems.
  • Keeps abreast of regulatory procedures and changes.
  • May direct interaction with regulatory agencies on defined matters.
  • Recommends strategies for earliest possible approvals of clinical trials applications.

SPECIALIST CAREER STREAM:
Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies using specialized knowledge and skills normally acquired through advanced education typically University.

DIFFERENTIATING FACTORS
Autonomy:
Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists may manage projects / processes.

Organizational Impact:
May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult and may require understanding of multiple issues job areas or specialties . Makes improvements of processes systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements.

Communication and Influence:
Communicates with senior internal and external customers and vendors. Exchange information of facts statuses ideas and issues to achieve objective and influence decisionmaking.

Leadership and Talent Management:
May provide guidance coaching and training to other employees within job area. May manage projects requiring delegation of work and review of others' work product .

Required Knowledge and Experience:
Requires advanced knowledge of job area combining breadth and depth typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience or advanced degree with a minimum of 2 years relevant experience.

Pay range $45-53/hr based on experience

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About North Haven, CT

Ready to kickstart your career in the vibrant town of North Haven, Connecticut? Discover exciting job opportunities in this dynamic area surrounded by picturesque landscapes and diverse community. With close proximity to the bustling city of New Haven and its renowned institutions like Yale University, North Haven offers a perfect blend of suburban charm and urban convenience. Enjoy exploring the charming boutiques and restaurants of downtown North Haven, or take a short drive to experience the cultural treasures of New Haven, including the Yale Art Gallery and Shubert Theater. Don't miss out on the chance to work and play in this thriving region filled with endless possibilities for personal and professional growth. Check out our job listings today and take the first step towards a fulfilling career in North Haven!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.