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Pfizer Regulatory affairs jobs in Chennai 2021

Pfizer Regulatory affairs jobs in Chennai 2021

Pfizer hiring Regulatory affairs executive Role in Chennai Location.

Department – Regulatory affairs
Designation – Executive
Location – Chennai

Qualification – Must-Have Bachelor’s Degree
Demonstrated experience

Proven ability to consistently deliver to time, cost and quality standards

Operational knowledge of hardware and software tools required for the job

Excellent organizational skills and attention to detail

Knowledge of documentation practices

Fluent in English, verbal and written

Role & Responsibilities :-

Contribute to the completion of project milestones and organize own work to meet project task deadlines.

Work in compliance and ensure delivery on regulatory benchmarks.

Work in collaboration across the organization with stakeholders to deliver efficiencies in regulatory submissions and processes.

Act as regulatory data subject matter expert in regions supported and escalate any potential compliance issues to management.

Support audit as part of regulatory data and system scope.

Update the appropriate regulatory requirements systems and database in a timely manner when changes occur in market regulations.

Perform monthly compliance report review and complete remediation activities in close partnership with Regulatory strategist teams.

Review audit reports from the systems and
resolve errors to ensure integrity of data.

Responsible for coordinating the labeling updating process of product, to ensure compliance with Pfizer labeling policy and local Board of Health (BoH) regulations.

Prepare and/or coordinate dossier preparation, guaranteeing quality dossiers, fulfilling country regulations and Pfizer standards in conjunction with regional teams.

Maintain systems and databases per internal Standard Operating Procedures (SOPs) and policies and adhere to Pfizer compliance standards.

Review, analyze, coordinate and provide feedback to Head of Regulatory Affairs in matters relating to new product submissions and post approval maintenance of products as required.

For more detailed Notification Click below link

Pfizer Regulatory affairs jobs in Chennai 2021
FDC; Regulatory affairs job vacancies at Mumbai 2021

FDC; Regulatory affairs job vacancies at Mumbai 2021

FDC pharma ltd hiring Drug regulations affairs department Job vacancy 2021

Department : Regulatory Affairs (API)
Designation : Sr. Executive / Assistant Manager

Experience 6 to 10 years
Job Location : Kandivali (W), Mumbai

Job Description :
For APIs Markets, to Develop regulatory strategies, implementation plan. Preparation and submission of CEP and its revisions, new DMFs & amendments, for US, Europe and all other regions.
Various overseas and local Customers requirements compliance. Review of documents, cross functional team communication. Good knowledge of ICH and other Regulatory Guidelines, aware of good Documentation practices.

Interested Candidates Send your updated resume on pravin.waghole@fdcindia.com

FDC; Regulatory affairs job vacancies at Mumbai 2021
Regulatory affairs Experience Jobs in Andheri; Encube

Regulatory affairs Experience Jobs in Andheri; Encube

Encube hiring Regulatory affairs Candidates

Designation – Assistant Manager/Manager

Department : Regulatory Affairs

Educational Qualification : M.Pharm

Work Experience : 6-8 years

Location : Andheri (East)

Key Deliverables

1. Defining EU/UK regulatory strategy.

2. Dossier review and complilation of MA application for EU/UK market.

3. In-depth knowledge of documents such as specification, batch record, method validation documents, stability data, container, closure system, DMF review.

4. Hands on experience in compiling eCTD.

5. Labeling related activites 6. Post Approval activities for EU/UK.

Skills Requirments

1. Team handling experience of 1-2 team members.

2. Preferred advantage if other
regulated market exposure e.g ROW market.

3. Thorough Knowlege on the review of CMC/clinical documentation required for submission.

4. Preferred advantage for having an exposure in topical products.

5. Good communication skills and interpersonal skills.

6. Ability to co-ordinate to project manage with external stakeholder.

Interested Candidates share your updated Resume to
durga.p@encubeethicals.com careers@encubeethicals.com

Regulatory affairs Experience Jobs in Andheri; Encube
Biocon Biologics; Regulatory affairs, R&D, Manufacturing jobs in Bangalore 2021

Biocon Biologics; Regulatory affairs, R&D, Manufacturing jobs in Bangalore 2021

Biocon Biologics hiring Regulatory affairs, Research and development, Manufacturing Job Recruitment Notification 2021

Job Location: Bengaluru

If you’re game for new challenges and want to grow in a dynamic environment that encourages constant learning, leveraging on your strengths, come join us in our journey of transforming patients’ lives with innovative and inclusive healthcare solutions.

Skill Sets:

Regulatory Affairs

Graduation or Post-Graduation degree in biotechnology or equivalent with 6-15 years of experience in below mentioned skill set:

1. Handling submissions in ICH regions.
2. Submission of Scientific advises clinical trial applications and dossiers.
3. Handling regulatory life cycle management. 4. Knowledge of ICH Guidelines and key MOW Market regulations.

RND – Biosimilar jobs

Post-Graduation degree in Biotechnology, Biochemistry- Full Time with 2-7 years of experience or PhD Biotechnology, Biochemistry – Full Time with 0-3 years of experience in below mentioned skill set:

1. Cell Culture (Upstream)
2 Drug Substance (Downstream)
3. Phys Chem Characterization (ADL)
4. Functional Characterization (Bioassay)
5. Drug Product Formulation 6. Pk & Immunogenicity

Manufacturing jobs

MSC / BSc / M Pharma /B Pharma / BE/ BTech / ME/ M Tech degree with 3-15 years of experience in below mentioned skill set

1. Upstream Manufacturing (Mammalian & Microbial)
2. Downstream Manufacturing (Mammalian & Microbial)
3. Process Engineering (USP & DSP)
4. MES
5. MSAT (Mammalian & Microbial)

Interview Details:

Date: 21st November 2021 | Time: 9:00 am to 12:00 pm

Venue: Hotel Radisson, Gachibowli – Miyapur Rd, Chhota Anjaiah Nagar, Hyderabad, Telangana 500032

Interested candidates may also email their resume to
mukesh.guleria@biocon.com for RND, nived.desai@biocon.com for Regulatory Affairs

& jyothirmai.mondi101@biocon.com for Manufacturing

Please Note:

1. Candidates who have attended an interview with Biocon Biologics in the last six months are not eligible.
2. Candidates must carry their updated resume, highest qualification certificate, latest increment letter and pay slip of last 3 months.
3. As part of COVID-19 safety measures, Candidates are requested to sanitize their hands at the entrance.
Maintain social distance and wear facemasks at all times at the walk-in event venue.

Fresher Regulatory Affairs Pharma jobs; Torrent Pharmaceuticals

Fresher Regulatory Affairs Pharma jobs; Torrent Pharmaceuticals

Torrent Pharmaceuticals Hiring freshers for Regulatory Affairs Department.


M pharmacy and Diploma Regulatory affairs Candidates have an opportunity by Torrent Pharmaceuticals, either Fresher and 01 years experience in Regulatory affairs department Candidates are eligible, selected candidates work as Trainee executive or Executive role.

full Detailed Job Description below.

Department – Regulatory Affairs

designation – Trainee Executive / Executive (Freshers)

Experience: 0- 01 Yrs.

Qualification: M Pharmacy & Diploma in Regulatory Affairs

Job Profile:

Preparation of Dossier, Publishing submission in E-CTD application

Preparation of Module -1 / Administrative documents

Product Lifecycle management CCF Evaluation, Variation preparation and filing

Interested Candidates may share their CVs on anupathale@torrentpharma.com

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