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Job Posting : Mgr, Regulatory Consulting (Biologics)

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Job title: Mgr, Regulatory Consulting (Biologics)

Firm: Syneos Health

Job description: Up to date: At the moment
Location: Asia Pacific – IND-Home-Primarily based, India, India
Job ID: 22005046

Description

JOB SUMMARY

Answerable for management of main assignments and shopper relationships. In session with the road supervisor, answerable for organizing and managing challenge groups and for the standard and timeliness of assignments. Supplies recommendation and help to purchasers and different associates in areas of experience. Ensures that the varied challenge associated duties are accomplished in conformity with all Firm insurance policies, Commonplace Working Procedures, and governmental rules. Contributes to enterprise improvement for regulatory capabilities.

Expertise required:

  • Require minimal 10 years of expertise in regulatory and Minimal 5 to six years’ expertise in Biologics regulatory CMC

JOB RESPONSIBILITIES

  • Authoring and assessment of CMC modules for Organic/Biosimilar regulatory functions for Developed markets e.g. US, EU by establishing and making use of CMC international regulatory methods, present regulatory tendencies.
  • Preparation of responses for HA queries, briefing packages for Scientific advices.
  • Contributes to planning for regulatory submissions in assigned area/nation/challenge.
  • Answerable for day-to-day administration of challenge groups and tasks.
  • Acts as a consultant of the regulatory division with different departments.
  • Helps enterprise improvement, together with era of repeat enterprise from current purchasers and proposal improvement.
  • develops, opinions, and screens challenge budgets, opinions shopper invoicing.
  • Screens private utilization and utilization of direct reviews.
  • Acts as a key level of contact for purchasers and regulatory authorities.
  • Supplies regulatory recommendation to Firm associates.
  • Conducts regulatory analysis on tasks as wanted.
  • Supplies strategic and operational recommendation to purchasers.
  • Arranges, leads, and reviews on shopper and regulatory company conferences.
  • Writes IND and product registration dossiers, medical reviews, and different regulatory paperwork. Manages challenge groups and preparation of regulatory submissions for conduct of INDs, product registrations, and put up approval upkeep actions.
  • Acts as a useful resource for technical data.
  • Participates in high quality enchancment efforts to extend general operational effectivity.
  • Contributes to the constructing of regulatory methods and infrastructure wanted for GRAS.
  • Develops fame for the Firm as business chief in Regulatory by attending and talking at business occasions akin to seminars, affiliation conferences, authoring articles for commerce journals, and participation in business affiliation by memberships and on committees.
  • Develops options to complicated issues.
  • Supplies inside coaching in applicable areas of experience to different departments.
  • Different Tasks:

Performs different work-related duties as assigned. Minimal journey could also be required (as much as 25%).

{Qualifications}

What we’re searching for

  • Masters diploma, ideally in a science-related discipline or equal expertise in science/regulatory/medical writing-related discipline or average pharmaceutical/medical system associated expertise. Average expertise in regulatory.
  • Demonstrated expertise in contributing to the preparation of regulatory submissions together with for instance IND, PMA, NDA, MAA, and CTD, together with digital submissions. Expertise in area of interest submissions akin to ODD, PIP/PMP a bonus.
  • Complete regulatory data and understanding of pharmaceutical and or medical system product improvement.
  • Wonderful interpersonal / communication abilities together with glorious written and verbal communication abilities.
  • Wonderful customer support abilities, with the flexibility to work each as a crew member and independently.
  • Good high quality administration and budgeting abilities.
  • Good folks administration, challenge administration, problem-solving, and decision-making abilities.
  • Superior abilities in Microsoft Workplace Functions.
  • Capability to work together with employees from a number of departments and places of work to ascertain challenge requirements.
  • Good initiative, adaptability, and pro-activity.
  • Sturdy analytical abilities, good consideration to element.
  • Capability to work concurrently on tasks, every with particular directions that will differ from challenge to challenge.
  • Fluent in talking, writing, and studying English.

Get to know Syneos Health
We’re the one full-service biopharmaceutical options firm on the planet. Which means we carry collectively one of the best medical and business minds to create a greater, smarter, sooner option to get medicines into the fingers of sufferers who want it most. Study extra about Syneos Health.

Extra Info:
Duties, duties, and tasks as listed on this job description are usually not exhaustive. The Firm, at its sole discretion and with no prior discover, could assign different duties, duties, and job tasks. Equal expertise, abilities, and/or training can even be thought-about so {qualifications} of incumbents could differ from these listed within the Job Description. The Firm, at its sole discretion, will decide what constitutes as equal to the {qualifications} described above. Additional, nothing contained herein needs to be construed to create an employment contract. Sometimes, required abilities/experiences for jobs are expressed in short phrases. Any language contained herein is meant to completely adjust to all obligations imposed by the laws of every nation wherein it operates, together with the implementation of the EU Equality Directive, in relation to the recruitment and employment of its staff. The Firm is dedicated to compliance with the Individuals with Disabilities Act, together with the availability of cheap lodging, when applicable, to help staff or candidates to carry out the important capabilities of the job.

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Anticipated wage:

Location: India

Job date: Sat, 14 May 2022 04:38:12 GMT

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