Formulation Regulatory Affairs

Role -Formulation Regulatory Affairs Role - US / Canada MarketLevel - Associate Manager / Manager - US MarketRequired Education/Exp:Experience Req.: 11 - 16 yrs.Qualification: - M.Sc. / M. Pharma.ResponsibilitiesHands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules.Experience and knowledge on life cycle...

Role -Formulation Regulatory Affairs Role - US / Canada MarketLevel - Associate Manager / Manager - US MarketRequired Education/Exp:Experience Req.: 10 - 16 yrs.Qualification: - M.Sc. / M. Pharma.ResponsibilitiesHands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules.Experience and knowledge on life cycle...

Role - Formulation Regulatory Affairs Role - US / Canada MarketLevel - Associate Manager / Manager - US MarketRequired Education/Exp:Experience Req.: 10 - 16 yrs.Qualification: - M.Sc. / M. Pharma.ResponsibilitiesHands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules.Experience and knowledge on life cycle...

Role - Formulation Regulatory Affairs Role - US / Canada MarketLevel - Associate Manager / Manager - US Market Required Education/Exp: Experience Req.: 11 - 16 yrs.Qualification: - M.Sc. / M. Pharma.ResponsibilitiesHands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules.Experience and knowledge on life cycle...

Role - Formulation Regulatory Affairs Role - US / Canada Market Level - Associate Manager / Manager - US Market Required Education/Exp: Experience Req.: 11 - 16 yrs. Qualification: - M.Sc. / M. Pharma. Responsibilities Hands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules. Experience and knowledge on...

Role - Formulation Regulatory Affairs Role - US / Canada MarketLevel - Associate Manager / Manager - US Market Required Education/Exp: Experience Req.: 10 - 16 yrs.Qualification: - M.Sc. / M. Pharma.ResponsibilitiesHands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules.Experience and knowledge on life cycle...

**Regulatory Affairs Associate** 2 to 5 years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts. - To provide regulatory input on procedural and CMC documentation requirements specific to as defined by Health Authorities for assigned deliverable(s) including: - Submission delivery strategy - Review of documents - Analysis of...

**Urgent Hiring || Formulation Development || Bangalore** Profile - Formulation Development (Only male) Experience - Min 5-8 years Ctc - Upto 8 lacs Location: - Bannarghatta, Bangalore Working days - 5 days (9 am to 6 pm) **Responsibilities**: - Literature search, Licensing, Formulation strategy preparation. Planning and execute development trials at...

Job Description - Regulatory Affairs AssociateYour mission, if you choose to accept, will be :ResponsibilitiesParticipate in the development of regulatory submission and approval strategy in multiple countries.Ensure compliance with FDA, ISO 13485, MDR, and other relevant regulatory requirements.Maintain awareness and understanding of new and existing...

Provide responses to regulatory agencies regarding product information or issues. - Train RA Assistant and staffs in regulatory policies or procedures. Coordinate internal discoveries and depositions with legal department staff. - Develop and maintain standard operating procedures or local working practices. - Establish regulatory priorities or budgets and...

**_Regulatory Affairs Associate _**: **Experience: RIM**: **Relevant experience in Regulatory and should be willing to work in EU Shifts (12:00 - 9.00 PM)**: - **Experience of handling RIM tools - Veeva Vault specifically.**: - **Basic Regulatory knowledge on regulations and Health Authorities.**: - **Excellent communication skills.** **Knowledge and...

Job Title: Regulatory Affairs Manager ICareer Level - DIntroduction to role:The Regulatory Affairs Manager I is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables, including delivery as an individual contributor, if required. The Regulatory Affairs...

Experience: 8 to 20 YearsLocation: Bangalore OR RemoteSkills: Regulatory Affairs, Clinical trial application, Clinical Trial Regulation, CDSCO10+ yrs relevant experience in Clinical Trial Regulatory Submissions.Experience in managing clinical trial studies, playing Regulatory Leads for Global trials, and exposure to the European market.Expertise in handling...

**About Us**: An established player in the B2B Pharma raw material space has recently launched an exciting new E-commerce platform **- CLYZO** **Position - Regulatory Affairs Associate.** An organization with a reputed history of 10+ years in the Pharma raw material industry, dealing in excipient products is looking for Regulatory Affair Executive having...

**Internal Title**:Regulatory Affairs Professional **External Title**:Deputy General Manager **Position Summary** To perform regulatory tasks as applicable to SHPL products pertaining to regulating authorities like radiation safety related certification from Atomic Energy Regulatory Board (AERB) for Zone India (India, Bangladesh, Nepal, Sri Lanka &...

Experience: 8 to 20 Years Location: Bangalore OR Remote Skills: Regulatory Affairs, Clinical trial application, Clinical Trial Regulation, CDSCO10+ yrs relevant experience in Clinical Trial Regulatory Submissions.Experience in managing clinical trial studies, playing Regulatory Leads for Global trials, and exposure to the European market.Expertise in...

Key ResponsibilitiesPreparation, review, and timely submission of ANDA in US market.Deficiency and life cycle management for the products filed in US.Review of technical (developmental and plant) documentations required for dossier submission.Providing necessary regulatory inputs to different cross functional teams (including CMO and CDMO projects) during...

Key ResponsibilitiesPreparation, review, and timely submission of ANDA in US market.Deficiency and life cycle management for the products filed in US.Review of technical (developmental and plant) documentations required for dossier submission.Providing necessary regulatory inputs to different cross functional teams (including CMO and CDMO projects) during...

Key ResponsibilitiesPreparation, review, and timely submission of ANDA in US market.Deficiency and life cycle management for the products filed in US.Review of technical (developmental and plant) documentations required for dossier submission.Providing necessary regulatory inputs to different cross functional teams (including CMO and CDMO projects) during...

**Responsibilities**: - Work closely with Engineering team through product development process and design activities - Author/participate in the design validation and process validations, IQ, OQ, PQ. - Prepare, review risk management files and support risk management activities including hazard analysis and FMEA. - Identify relevant guidance documents,...