Mgr, Regulatory Consulting (Biologics)

  WORK FROM HOME

Job title: Mgr, Regulatory Consulting (Biologics)

Company: Syneos Health

Job description: Updated: Today
Location: Asia Pacific – IND-Hyderabad-DLF-Cybercity, India, India
Job ID: 22005046-IND518

Description

JOB SUMMARY

Responsible for leadership of major assignments and client relationships. In consultation with the line manager, responsible for organizing and managing project teams and for the quality and timeliness of assignments. Provides advice and assistance to clients and other associates in areas of expertise. Ensures that the various project related tasks are completed in conformity with all Company policies, Standard Operating Procedures, and governmental regulations. Contributes to business development for regulatory functions.

Skills required:

  • Require minimum 10 years of experience in regulatory and Minimum 5 to 6 years’ experience in Biologics regulatory CMC

JOB RESPONSIBILITIES

  • Authoring and review of CMC modules for Biological/Biosimilar regulatory applications for Developed markets e.g. US, EU by establishing and applying CMC global regulatory strategies, current regulatory trends.
  • Preparation of responses for HA queries, briefing packages for Scientific advices.
  • Contributes to planning for regulatory submissions in assigned region/country/project.
  • Responsible for day-to-day management of project teams and projects.
  • Acts as a representative of the regulatory department with other departments.
  • Supports business development, including generation of repeat business from existing clients and proposal development.
  • develops, reviews, and monitors project budgets, reviews client invoicing.
  • Monitors personal utilization and utilization of direct reports.
  • Acts as a key point of contact for clients and regulatory authorities.
  • Provides regulatory advice to Company associates.
  • Conducts regulatory research on projects as needed.
  • Provides strategic and operational advice to clients.
  • Arranges, leads, and reports on client and regulatory agency meetings.
  • Writes IND and product registration dossiers, clinical reports, and other regulatory documents. Manages project teams and preparation of regulatory submissions for conduct of INDs, product registrations, and post approval maintenance activities.
  • Acts as a resource for technical knowledge.
  • Participates in quality improvement efforts to increase overall operational efficiency.
  • Contributes to the building of regulatory systems and infrastructure needed for GRAS.
  • Develops reputation for the Company as industry leader in Regulatory by attending and speaking at industry events such as seminars, association meetings, authoring articles for trade journals, and participation in industry association through memberships and on committees.
  • Develops solutions to complex problems.
  • Provides internal training in appropriate areas of expertise to other departments.
  • Other Responsibilities:

Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).

Qualifications

What we’re looking for

  • Masters degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field or moderate pharmaceutical/medical device related experience. Moderate experience in regulatory.
  • Demonstrated experience in contributing to the preparation of regulatory submissions including for example IND, PMA, NDA, MAA, and CTD, including electronic submissions. Experience in niche submissions such as ODD, PIP/PMP an advantage.
  • Comprehensive regulatory knowledge and understanding of pharmaceutical and or medical device product development.
  • Excellent interpersonal / communication skills including excellent written and verbal communication skills.
  • Excellent customer service skills, with the ability to work both as a team member and independently.
  • Good quality management and budgeting skills.
  • Good people management, project management, problem-solving, and decision-making skills.
  • Advanced skills in Microsoft Office Applications.
  • Ability to interact with staff from multiple departments and offices to establish project standards.
  • Good initiative, adaptability, and pro-activity.
  • Strong analytical skills, good attention to detail.
  • Ability to work concurrently on projects, each with specific instructions that may differ from project to project.
  • Fluent in speaking, writing, and reading English.

Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.

Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Share this job

Expected salary:

Location: Hyderabad, Telangana

Job date: Sun, 29 May 2022 02:43:30 GMT

Apply for the job now!