722 Regulatory Affairs jobs in India

Position Overview:

We are seeking a detail-oriented RA-CMC Associate to support end-to-end submissions for global markets. Required exposure includes
Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.

Key responsibilities:

• Prepare
  Variation documents and/or evaluate post-approval CMC changes
  in compliance with global regulatory requirements.
• Contribute to
  Lifecycle Management (LCM) activities
  by helping to compile and review CTD dossier modules.
• Compile initial dossiers
  (Modules 2 & 3)
  for
  US / EU / SA / WHO / ANZ / Other Countries
  .
• Provide regulatory strategies and conduct evaluations of post-approval CMC changes considering
  ICH
  and country-specific guidelines.
• Manage compilation and submission of variations/supplements for US/EU/SA/WHO/ANZ/Other countries.
• Utilize
  Veeva Vault RIM
  to track queries and manage submission workflows.
• Review technical documents from manufacturing sites, including:
• Specifications
• Batch Manufacturing Records
• Process & Analytical Validations
• Batch Analysis Data
• Stability Data

Experience Requirement:

• 3+ years of experience in managing
  Initial submissions
  ,
  Variations
  , and full
  LCM (Lifecycle management)
  deliverables for the global markets.
• Must have experience with Veeva Vault RIM
• Proficient in ICH guidelines and regulatory guidelines for US/EU/SA/WHO/ ANZ/Other countries.
• Review of technical documents from manufacturing sites like of Specifications, Batch Manufacturing Records, Validations, Batch analysis data, Stability etc.
  required for compilation of dossier sections/Variations.
• Hands on experience in initial dossier compilation for US/EU/SA/WHO/ ANZ/Other countries
  (Module 2 & 3).
• Experience in providing Regulatory strategies/ Evaluation by performing assessment of post approval CMC Changes considering global regulatory requirements.
• Compilation and submission of Variations/ supplements for US/EU/SA/WHO/ANZ/Other countries as per applicable regulatory guidelines.

Regulatory Affairs Job Opportunity

Desired Experience : 3- 9 years

Job Location : Genome Valley, Shameerpet, Hyderabad

Preferred Industry : Vaccines / Biotech

Designation: Senior Executive/ Executive

Qualification: M. Pharmacy/ M. Sc/ B. Pharmacy

Job Responsibilities:

• Responsible for Regulatory submission to Indian NRA, Emerging Markets, Regulated Markets and World Health Organization.
• Experienced in handling, management and expansion of product portfolios, markets/ territories.
• Experienced in the preparation, review and submission of applications/ response to RCGM vide IBSC.
• Expertise in preparation, compilation and submission of Indian NRA applications (Eg: Form CT 10, 16, CT18, 40, 10, Export NoC, etc., but not limited)
• Well versed with Indian NRA submission portals, IBKP, SUGAM, NSWS, ODLS/ ONDLS, etc.
• Author, review and compilation of Regulatory Packages like Briefing documents, Scientific package, Pre-IND packages, Clinical Trial, Expedited request, Pre-qualifications, etc.
• Author, review, compile and submission of Marketing Authorization Applications (CTD/ ACTD/ eCTD) in India, Emerging Markets, Regulated Markets and Vaccine Prequalification Dossier to WHO.
• Application for Post Approval Change(s), Variations and Comparability packages
• Author, review and submission of responses to India, EM, WHO and Regulated markets.
• Hands-on experience with MS office tools, PDF, Track Wise, DMS, Veeva Vault, Lorenz/ Pharma ready, etc.
• Handling the Health Agency audits for India, EM, Regulated and WHO inspections
• Coordination with cross functional departments like QA, QC, Production, Warehouse, Distribution, Marketing and various teams (Internal & External).
• Review of Artworks (Labels and Package Insert) and Pack Profiles.
• Any other regulatory support required by the organization per submission need.

Interested Candidates having relevant experience can send in their CVs to by mention the subject as Applying for "Regulatory Affairs"

Details of the requirement are given below for your reference:

1) Client Company : Pharmaceuticals Industry

2) Position : Regulatory Affairs

3) Experience Required : 3+ years

4) Salary Negotiable : Rs PM to 5000 PM

5) Job Location : Ahmedabad

6) Job Description :

A) To review dossier prepared by executives and trainees and submit to client along with artworks for countries like ASIA, LATAM & ROW Market.

B) To work on Renewals of Registration Certificate for countries.

C) Ensure that a companys products comply as per current ICH and Country Guidelines. D) Courier of Legalized Documents such as COPP, FSC, POA, Manufacturing

Agreement, Declaration letters for updation of artworks, GMP certificate to respective clients and countries.

E) Courier of Samples for New registration and Renewal Purpose as per client requirements for reanalysis and first commercial batch analysis purpose.

F) Arrangement of Sample and Legals required as per new registration and Renewal purpose from Legal team, Production department and FRD.

G) Follow up with FRD and Microbiology department for test requirements by client on batch FPCOA.

H) Arrangement and courier of Working Standards from QC department to Client or country as required for testing purpose.

I) Resolving queries from client regarding new registration and renewals as per country requirements.

J) Updation and maintenance of Country Specific Global Status sheets for New registration, Renewals and Query Status.

K) Follow up for Review and corrections of Artworks required for New registration and Renewals with Artwork department as per client and company requirements.

L) Follow up and arrangements of Documents required for Dossier Preparation with QA, QC, ARD and Micro Department as per country guidelines.

Interested candidates can apply immediately.

With Regards,

Gopi (HR)

Job Type: Permanent

Pay: ₹20, ₹50,000.00 per month

Work Location: In person

FOR NEW REGULATORY PROJECT, Chengalpattu

JOB DESCRIPTION

• In depth understanding of EU, ROW markets and local regulations, guidelines and industry standards.
• Experience in EU filings, ROW and local regulatory filings.
• Ability to interpret complex regulatory documents and data
• Excellent written and verbal communication skills to interact with regulatory bodies and internal teams.
• Accuracy and thoroughness in preparing and reviewing regulatory documents.

Experience:
4- 8 Years

Qualifications:
B.Pharm/ M.Sc

The role is to assist in providing the regulatory administration activities of regional regulatory function. This position is responsible for organizing, revising and maintaining all regulatory documents within the regulatory department. The individual will assist in the registration of products by preparing and submitting documentation needed for registration in India. The individual will assist the team in any other responsibility as desired for regulatory work.

Education:

• Postgraduate in Master of Business Administration (Pharmaceutical Management)
• Graduate in Pharmacy

Experience:

4-5 years experience in FMCG/Pharma Industry in the field of pharmaceutical, general category products

Company Description

Tablets India Limited (TIL) is a leading manufacturer of pharmaceutical and nutraceutical formulations. Our therapeutic range includes nutritional supplements, haematinics, hepatoprotectives, antipyretic solutions, G.I. lavage preparations, anti-ulcerants, and osteoporotic formulas. We have also ventured into the probiotic segment with innovative products for gastrointestinal and women's health. Our commitment to quality and innovation has made us a trusted name in the industry.

Role Description

This is a full-time on-site role at our New Regulatory Project Site Located @ Chengalpattu

Looking for a Regulatory Affairs professional specializing in the EU market. The Regulatory Affairs specialist will be responsible for preparing and reviewing regulatory documentation, ensuring compliance with regulatory requirements, and managing submissions to regulatory bodies. Key tasks include maintaining up-to-date knowledge of regulatory standards, coordinating with relevant departments, and ensuring that all products meet EU regulations.

Qualifications

• Minimum of 5 years of Experience in Regulatory Documentation and Regulatory Submissions
• Knowledge of Regulatory Compliance and Regulatory Requirements
• Expertise in Regulatory Affairs
• Excellent organizational and communication skills
• Ability to work collaboratively with cross-functional teams
• Attention to detail and strong problem-solving skills
• Bachelor's degree in Pharmacy, Life Sciences, or a related field
• Experience in the pharmaceutical industry is a plus

JOB TITLE :
Regulatory Affairs - Senior Executive - ROW markets (Philippines, Kenya, Ethiopia, Nigeria)

WHY SHOULD YOU JOIN SURGEWAY BIOSCIENCES?

As a fast-growing organization, we believe in practicing openness and giving opportunities to one and all, to experiment and exhibit their talent. We provide a structured way of growth. We provide in-house training that teaches coaching skills, team collaboration, performance enhancement, as well as how to be an effective contributor. At Surgeway Biosciences, we offer much more than just a job. We strive to give you a Promising and Bright Career path.

PRIMARY GOAL FOR THE ROLE

Complete technical know how about dossiers, and dossier compilation
(for ROW markets)
- and generating new dossiers and reviewing existing dossiers, in a timely and accurate manner.

Roles & Responsibilities:

To prepare and compile a registration dossier as per the CTD / ACTD / Country specific guidelines -

specifically for ROW markets (Philippines, Nigeria, Zambia, Ethiopia, Kenya, Myanmar, Cambodia,)

Must be aware of the contents of a Dossier, and should be knowledgeable about all the documents attached in dossiers

To prepare, review /check artwork, pack insert, SmPC, etc.

To verify all technical documents and information received from various departments at the manufacturing site.

To verify specification of excipients, active, finished product, and packaging material

and all required documents.

Must be aware of Biosimilars/Drug products submission procedure for ROW countries

Must be aware of the ICH guidelines and the updates on the same

To reply to any queries raised by respective regulatory authorities, in a timely manner.

Maintains the highest level of submission standards.

Requirements:

Prefer professionals with experience in Dossier preparation and Submission-

for
ROW markets
(Especially South East Asia and East Africa)

Two to Three years' experience
in Pharma Regulatory Affairs will be preferred

Immediate Joining or 15-day's Notice Period
is preferred.

Candidate Profile:

M.Pharm candidate
with 2-3 years of experience in the
RA department (
for
ROW
countries)

Good communication skills in English

Ability to grasp new concepts quickly

Must have a systematic approach to solving problems.

Must be able to understand the techniques and processes used

Excellent PC skills, should be proficient with the usage of the internet as a tool to find

necessary and useful information.

Must be organized- timely, and with information/data.

We are seeking a Regulatory Affairs Executive Freshers To Work in the MNC For Hyderabad Location

The ideal candidate should have hands-on experience in compiling and reviewing ACTD and CTD dossiers for various regulatory submissions.

Required Candidate profile

B.Pharm & M.Pharm With Knowledge of Regulatory Affairs CTD ECTD DMF and Regulatory Guidelines are Eligible to Apply

The mission of the Regulatory Affairs Specialist (RAS) is to prepare and file demands for regulatory approval of the products of one's company. Biotechnology companies, which have lesser means than large pharmaceutical companies, prioritize experienced candidates or else turn to consultants. The Regulatory Affairs Specialist in biotechnology thus plays a very strategic role and is involved in all stages of the process, whereas its counterpart in the pharmaceutical industry has more delineated responsibilities, involving more administrative tasks.

The Regulatory Affairs Specialist stays with the same company for an average of 10 to 15 years; the rate of turnaround is therefore low. Networking is very much encouraged, through joining various associations to participate in conferences and exhibitions, and also to access current literature. Presently, there is a strong demand for Regulatory Affairs Specialists in medical device companies.

Main duties of the regulatory affairs specialist

• Prepare, coordinate and supervise regulatory submissions
• Review product conformance and assure compliance
• Implement different strategies in order to meet evolving regulatory initiatives
• Register products according to provincial guidelines and regulations of third party suppliers
• Keep current with regulations
• Participate in conferences and interdepartmental meetings

Job Types: Full-time, Permanent, Fresher

Pay: ₹25, ₹43,755.49 per month

Benefits:

• Cell phone reimbursement
• Health insurance
• Provident Fund
• Work from home

Work Location: In person