Assistant Manager Regulatory Affairs – Veterinary

From 8 to 12 year(s) of experience
₹ 7,50,000 - 12,00,000 P.A.

Job Description

KEY RESPONSIBILITIES:

- Responsible for submission and monitoring of successful pharmaceutical licence applications by liaising with global regulatory agencies to obtain granted licences for Veterinary products in timely manner.

- Responsible for management of regulatory submissions and procedures for scientific advice procedures, clinical trial applications, marketing authorisation applications, post-authorisation procedures, waivers and/or deferrals for Veterinary products.

- Contribute to the development of the overall regulatory strategy and BE/clinical plan for development of Veterinary products, focusing on studies required for product decision or regulatory submission.

- Responsible for new product submissions, life cycle management and submission of deficiency responses/variations in timely manner.

- Liaising with global regulatory agencies to obtain granted licences in timely manner.

- Co-ordination with all stake holders for smooth regulatory submissions.

- Review and approval of R&D product strategy documents, Nonclinical assessments and GMP documents.

- Keeping up to date with regulatory issues in drug development processes and working to eliminate or minimize regulatory barriers.

- Excellent time and manpower management with quality output.

- Ability to keep up-to date with pharmaceutical trends and developments within the industry.

- Handling of regulatory audits and support the self-inspection programme from regulatory point of view.


ESSENTIAL EXPERIENCE, SKILLS AND ABILITIES

  • EXPERIENCE:

- 8 to 12 years of experience in the Regulatory affairs (Veterinary), especially for Europe market.

- Able to manage team for equal work distribution with quality output.

- Able to manage submission of new products dossier/Deficiency Response, Post- Approvals and renewals.

- Able to resolve issues during development for regulatory concerns (i.e., Prototype development trials and bio-waiver).

- Able to resolve any issue of API/Excipient manufacturer for regulatory concerns.

- Able to maintain all the regulatory status updates.

  • SKILLS AND ABILITIES:

- Sound knowledge of Regulatory guidelines and eCTD software.

- Good communication skill, both written and verbal.

- Can give quality output in any circumstances.

- Previous experience in a similar role is required.

- Can demonstrate excellent pharmacological and analytical skills.

- Ability to demonstrate openness to change.

- A conscientious and innovative individual who shows high attention to detail.

- Possess good working knowledge of Microsoft Office.

- A degree in medicine is an advantage but not essential.


Role:Regulatory Affairs Compliance

Salary: 7,50,000 - 12,00,000 P.A.

Industry:Pharmaceutical & Life Sciences

Functional Area:Legal & Regulatory

Role Category:Corporate Affairs

Employment Type:Full Time, Permanent

Education

PG:MS/M.Sc(Science) in Veterinary Science,M.Pharma in Pharmacy

Company Profile

SYRI Research Pvt. Ltd.

SyriMed previously known as Thame Laboratories Licensed Medicines Division is one of the leading Pharmaceutical Companies in the UK specialising in the development, licensing, manufacture and marketing of liquid medicines.


Established during 2004 in Ruislip, West London; SyriMed with the experience from the development and manufacture of unlicensed medicines started in 2014 to obtain marketing authorisations for its unlicensed liquid medicines. In May 2020, SyriMed held over 50 marketing authorisations for liquid medicines within the UK.


WHAT WE DO

SyriMeds success stems from its vibrant and productive Research and Development Department which develops and manufactures formulations for licensed medicines . All of SyriMeds formulations for which it holds marketing authorisations have been developed by SyriMeds own scientists.


SyriMed manufactures licensed medicines in its own facilities that meet the quality requirements of EU Good Manufacturing Practice (GMP).


Our in-house laboratories test the medicines manufactured to ensure they meet the strict requirements set by regulatory authorities.

Company Info
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Contact Company:SYRI Research Pvt. Ltd.

Address:No.2, B.P. Estate, N.H. No.8, Opp. Sitaram Super Market, Chhani, Vadodara - 391740

Reference Id:SRPL/RAVET/11/01

Website:https://www.syrimed.co.uk/