Regulatory Affairs Officer

**Regulatory Affairs Officer Duties & Responsibilities** The role and function of a Regulatory Affairs Officer includes the following duties and responsibilities: - Preparing submissions of licence variations and renewals to strict deadlines; - Ensuring that a company’s products comply with regulations; - Keeping abreast of international legislation,...

The role and function of a Regulatory Affairs Officer includes the following duties and responsibilities: - Preparing submissions of licence variations and renewals to strict deadlines; - Ensuring that a company’s products comply with regulations; - Keeping abreast of international legislation, guidelines and customer practices in all countries that the...

1. Management of product lifecycle for Particular Market. 2. Dossier Preparation - 3. Query Response 4. Post Approval changes 5. Variation Filing 6. Coordination with cross functional team 7. Module 1-5 8. In EUROPE MRP,DCP & National 10. Reviewing Product information as per QRD Requirement **Job Types**: Full-time, Permanent **Salary**:...

**Regulatory Affairs Specialist duties and responsibilities** - Ensuring compliance with all regulatory requirements - Maintaining regulatory documentation database - Assisting with the preparation and submission of all regulatory reports - Providing accurate reviews of data and reports - Ensuring accurate and timely submissions to regulatory agencies -...

**Job Title: Regulatory Affairs for a reputed pharmaceutical company** 1. Review all technical documents for submission of ANDA submission and post-approval submissions. 2. Ensuring all compiled ANDAs comply with current FDA guidelines and expectations to minimize deficiencies. 3. Preparation and review of pre-ANDA meeting packages, and controlled...

**Regulatory Affairs Specialist duties and responsibilities** - Ensuring compliance with all regulatory requirements - Maintaining regulatory documentation database - Assisting with the preparation and submission of all regulatory reports - Providing accurate reviews of data and reports - Ensuring accurate and timely submissions to regulatory agencies -...

Required Regulatory Affairs Executive in Pharma Industry. Industry Background:Pharma (HO) Post: Regulatory Affairs Executive Gender: Preferably Female. Qualification : - M. Sc / B. Sc / M. Pharm / B. Pharm. Degree / Diploma in Regulatory Affairs. **Position 4 : Regulatory Executive (preferably female)** **Eligibility**: - M. Sc / B. Sc / M. Pharm / B....

VACANCY REGULATORY AFFAIRS EXECUTIVE (Pharma Company is manufacturing veterinary products) Job Location: Mumbai Maharashtra Eligibility: - M. Sc / B. Sc / M. Pharm / B. Pharm. Degree / Diploma in Regulatory Affairs. - Should have good knowledge of preparing registration of Drugs & Feed Supplements in different countries - Minimum 2 years experience in...

At Ultratech India Limited, we believe employees are at the heart of all that matters. Connected in purpose by career, life, and health. The best people produce the best products and thus Ultratech is constantly on the lookout for bright and ambitious team players who have a strong commitment towards the organization. **Regulatory Affairs Executive**: ...

Provide expert regulatory input to strategic decision making; including portfolio review, prioritization, and external communications, Product packaging, Artwork etc.  Provide expert regulatory input to in-licensing evaluations and due diligence activities  Provide advice about regulations to manufacturers/scientists  Ensure that quality...

Profile-Regulatory & Compliance officer Experience-min 3 to 4 year experience in same industry, should be worked in export regulation affairs for FMCG/cosmetic/pharma industry Qualification - B.pharma/Graduate in any discipline,with PG/Diploma in import & Export Location -Mumbai(Parel) **Job Types**: Full-time, Permanent **Salary**: ₹40,000.00 -...

Key Responsibilities: - Should have 2 Years of Experience in Regulatory Affairs - Coordinate with Plant and associated departments to facilitate the dossier requirements. - Review of PVP PVR, Stability, PDR, BMR, and other directly or indirectly linked Quality Section in CTD/ACTD - Experience in handling markets like African Countries, the Philippines,...

1) Assisting the Export Department for legal transactions.2) Coordination of CIB License. 3) Coordination for the Registration of Comprehensive Crop pesticide. 4) Manage documentation related to MPCB Works. 5) Manage documentation related to Factory Act, Contract labour. registration. 6) Coordinate Approval of O Form & principal certificate of dealers,...

We are Hiring for Kan Biosys Pvt Ltd Biotechnology Company Pune.Qualification Required: B.sc (All Field of Life science), M.sc/MBA/MPMDesired profile:1) Assisting the Export Department for legal transactions.2) Coordination of CIB License. 3) Coordination for the Registration of Comprehensive Crop pesticide. 4) Manage documentation related to MPCB Works. 5)...

Designation : Regulatory SpecialistExperience : 7+Location : PuneQualificationsBachelor of Science in science and/or engineering field8 - 12years of regulatory experience in medical device industry (equivalent industry/educational experience may be considered)Thorough working knowledge of applicable FDA, ISO, EU and/or other region-specific medical device...

Designation : Regulatory Specialist Experience : 7+ Location : Pune Qualifications Bachelor of Science in science and/or engineering field 8 - 12years of regulatory experience in medical device industry (equivalent industry/educational experience may be considered) Thorough working knowledge of applicable FDA, ISO, EU and/or other region-specific medical...

Designation : Regulatory SpecialistExperience : 7+Location : PuneQualificationsBachelor of Science in science and/or engineering field8 - 12years of regulatory experience in medical device industry (equivalent industry/educational experience may be considered)Thorough working knowledge of applicable FDA, ISO, EU and/or other region-specific medical device...

Designation : Regulatory SpecialistExperience : 7+Location : PuneQualificationsBachelor of Science in science and/or engineering field8 - 12years of regulatory experience in medical device industry (equivalent industry/educational experience may be considered)Thorough working knowledge of applicable FDA, ISO, EU and/or other region-specific medical device...

Duties & responsibilities: To prepare and collate high quality documentation for all regulatory submissions. To liaise with relevant internal departments and external contacts to ensure regulatory requirements for these submissions are met and to proactively communicate with regulatory authorities in order to expedite approval of submissions To anticipate...

**Responsibilities** - Life cycle management and Maintenance of regulatory filings including annual reports and supplements to US FDA. - Preparation of registration submissions, in CTD (Clinical Trial Dossier) format, for biopharmaceutical products for approval by the US FDA, European Regulatory Authorities and worldwide, as required. - Monitoring the...