Regulatory Affairs

**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 -...

**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) 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,...

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/MPM Desired 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...

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)...

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...

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...

Job Description: Accountabilities/Responsibilities: Regulatory Affairs Management- · Understands the regulatory framework, including regional trends, for various types of applications and procedures for biological therapeutic products (Biologics, Biosimilar, Novel Biologics and Vaccines) in India and ROW markets. · Provides regulatory input on...

Job Description: Accountabilities/Responsibilities:Regulatory Affairs Management- · Understands the regulatory framework, including regional trends, for various types of applications and procedures for biological therapeutic products (Biologics, Biosimilar, Novel Biologics and Vaccines) in India and ROW markets.· Provides regulatory input on procedural and...

Job Description: Accountabilities/Responsibilities:Regulatory Affairs Management- · Understands the regulatory framework, including regional trends, for various types of applications and procedures for biological therapeutic products (Biologics, Biosimilar, Novel Biologics and Vaccines) in India and ROW markets.· Provides regulatory input on procedural and...

Key Responsibilities: - Statutory Compliance Ensure all compliance with the Companies Act, and other applicable laws and regulations. Due diligence, committee formation, and overlooking other routine compliances - Board and Committee Meetings: Assist in the organization and coordination of board and committee meetings. Prepare and circulate meeting...

**Job Type - Fresher or Internship level** Clinical Research Associates manage clinical trials and studies pertaining to biotechnological and pharmaceutical products, drugs and procedures. A Clinical Research Associate, also known as a CRA, conducts research to ensure these products are safe. **Responsibilities**: **1. Assist in Protocol Development**: -...

About the internship:Selected intern's day-to-day responsibilities include: 1. Taking care of the regulatory affairs of the company and Working on statutory compliances2. Drafting legal contracts and agreements with company's associates and clients.3. Identifying Collaborators and establishing collaboration or joint ventures to carry out company's...

**Company**: Sorigin Services Pvt Ltd **Location** Pune **Experience** 5-6 Years **Key Skills** Company Secretarial Functions, Compliance, Secretarial Activities, FEMA, Companies Act, Securities Law, Corporate Law **Position: Company Secretary** **Qualification: CS** **Experience: 5 to 6 years** **Location: Pune** **Job description** **Roles and...