675 Regulatory Affairs Associates jobs in India

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

Company Description

RiconPharma India Pvt Ltd develops and manufactures products across various dosage forms, primarily in our U.S. and Swiss facilities. Our innovative products are manufactured to the highest standards, aimed at improving consumer access while reducing overall healthcare costs. We strive to enhance the healthcare continuum by delivering high-quality, affordable solutions to the market.

Role Description

This is a full-time, on-site role for a Regulatory Affairs - Sr Associate specializing in Parenteral Dosage Forms, specifically for USFDA regulations. The position is located in Hyderabad. The day-to-day tasks include preparing regulatory documentation, ensuring regulatory compliance, understanding regulatory requirements, submitting regulatory submissions, and managing all aspects of regulatory affairs related to parenteral dosage forms.

Qualifications

• Skills in Regulatory Documentation and Regulatory Submissions
• Knowledge of Regulatory Compliance and Regulatory Requirements
• Experience in Regulatory Affairs
• Excellent written and verbal communication skills
• Detail-oriented with strong analytical skills
• Bachelor's degree in Pharmacy, Chemistry, or a related field
• Experience with USFDA regulations is a plus
• Ability to work independently and as part of a team

Role & responsibilities

The Regulatory Affairs (RA) & Global Registration Executive/Manager will be responsible for managing end-to-end global regulatory submissions, maintaining compliance with regional and international regulatory requirements, and facilitating timely registration and market access for medical devices across multiple geographies.

• Prepare and submit dossiers (510k, CE, CDSCO, etc.) as per country-specific regulations. - Maintain registration records and handle renewal processes.
• Monitor global regulatory updates and assess product impact. -
• Coordinate with QA, R&D, and marketing for data collection and documentation. -
• Respond to regulatory queries and deficiency letters.
• Support audits and inspections by regulatory bodies.

Preferred candidate profile

• Knowledge of global regulations: USFDA, MDR, CDSCO, TGA, SFDA, etc.
• Hands-on with portals: eSTAR, SUGAM, EUDAMED.
• Experience in technical file creation, labeling, UDI, and ISO 14971 risk documentation
• Strong communication and documentation skills -
• Attention to detail and time management
• Proficient in MS Office - Problem-solving and multi-tasking abilities

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

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.

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

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