Regulatory Affairs Officer

4 weeks ago

Vadodara, India Asoj Soft Caps Full time

Responsibilities

As a regulatory affairs officer:

  • ensure that a company's products comply with the regulations of the regions where they want to distribute them
  • keep up to date with national and international legislation, guidelines and customer practices
  • respond to queries from medical bodies like the Medicines and Pertaining to that Guidelines.
  • collect, collate and evaluate scientific data from a range of sources
  • develop and write clear arguments and explanations for new product licences and licence renewals
  • prepare submissions of licence variations and renewals to strict deadlines
  • monitor and set timelines for licence variations and renewal approvals
  • work with specialist computer software and resources
  • write clear, accessible product labels and patient information leaflets
  • plan and develop product trials and interpret trial data
  • advise scientists and manufacturers on regulatory requirements
  • provide strategic advice to senior management throughout the development of a new product
  • project manage teams of colleagues involved with the development of new products
  • oversee product trials and interpret trail data
  • undertake and manage regulatory inspections
  • review company practices and provide advice on changes to systems
  • liaise with, and make presentations to, regulatory authorities
  • negotiate with regulatory authorities for marketing authorisation
  • take part in the development of marketing concepts and approve packaging and advertising before a product's release. Role & responsibilities

Preferred candidate profile

  • Regulatory Affairs

    7 days ago

    Vadodara, Gujarat, India Sai Placement Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    URGENT OPENING FOR REGULATORY AFFAIRS OFFICER/ SR OFFICER LOCATION VADODARA Position:-Regulatory Affairs Officer/ Sr OfficerLocation:-VadodaraExperience:-1 to 3 Yrs (Formulation)Qualification :- B.Pharm/ M.Pharm Required Candidate profilePreparing dossiers as per country-specific guidelines.Compiling and reviewing documents.Coordinating with QA for...

  • Regulatory Affairs Officer

    2 weeks ago

    Vadodara, Gujarat, India Samarthhrconsultant Full time

    Bachelor's degree in Chemistry, Environmental Science, or related field. Advanced degree (e.g., MS, PhD) preferred. - 4+ years of experience in regulatory affairs within the agrochemical/pesticide. - In-depth knowledge of pesticide regulations (e.g., CIBRC/EPA, EU, other country etc.) and registration requirements. - Experience with regulatory submissions,...

  • Regulatory Affairs Executive

    3 days ago

    Vadodara, Gujarat, India Amico Formulations LLP Full time ₹ 2,50,000 - ₹ 3,00,000 per year

    POST: RA OFFICER/EXECUITVELOCATION: JAROD, VADODARAEXPERIENCE: 2-3 YEARSExperience in handling regulatory affairs for ROW market mainly Latin American, African & Asian countries for Pharma Formulations.Preparation, compilation & Review of Registration documents that include Administrative & Technical.Reviewing the technical documents provided by QA, QC,...

  • Regulatory Affairs Assistant

    1 week ago

    Jarod, Vadodara, Gujarat, India Briyosis Soft Caps Pvt Ltd Full time

    Job description **Company Description** Briyosis Soft Caps Pvt. Ltd. is a privately-owned contract manufacturer of custom dietary supplement formulations. Based in Vadodara, India, we are an FDA registered and WHO-GMP certified company. With our high-efficiency encapsulation lines operating 24/7, we have the capability to produce over 3 billion soft-gels...

  • Regulatory Affairs Specialist

    1 day ago

    Vadodara, Gujarat, India Ami Lifesciences Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Role & responsibilitiesResponsible for Drug Master Filing submissions to various regulatory agencies like USFDA, European Agencies, Brazil, and other semi-regulatory countries.Review and submission of Response to queries raised on DMF by USFDA, and other agencies.Review and submission of Amendments and revisions of Drug Master Files.Review and ensuring the...

  • Regulatory Affairs Executive

    2 days ago

    Vadodara, Gujarat, India Ronak Group Full time

    Looking for an Enthusiastic, Efficient & Trustworthy Senior Executive - Regulatory Affairs for a Leading MNC “**Ronak Group”** **Company: Ronak Group (MNC)** Position**:Executive / Senior Executive - Regulatory Affairs** Experience: 2 to 7 Years Location: Vadodara, India We are looking for Energetic & Goal Oriented **Executive / Senior Executive -...

  • Executive Regulatory Affairs

    5 days ago

    Vadodara, Gujarat, India Exemed Full time ₹ 4,00,000 - ₹ 12,00,000 per year

    Responsible for Regulatory Affairs functions at Exemed Pharmaceuticals Luna.Responsible for Issues Letter of Access, Letter of commitment and CEP certificate for customer as per specific regulatory requirement.To prepare commitment, Declaration and Statement certificate for customer as per specific regulatory requirement.Responsible for prepare and review...

  • Executive Regulatory Affairs

    2 weeks ago

    Vadodara, India Stellar Formulations Industries Pvt Ltd Full time

    1. Preparation, Review and Submission of the Dossiers as per CTD/ACTD guidelines as well a country specific guidelines. 2. Compilation of Dossiers and quality documents as per checklist in the guidelines. 3. Review of artworks as per the Regulatory requirements 4. Inter Department coordination to arrange and review of documents and samples for Regulatory...

  • Senior Manager/Director of Regulatory Affairs

    2 weeks ago

    Vadodara, India AIMS OXYGEN PRIVATE LIMITED Full time

    Company Description AIMS OXYGEN PRIVATE LIMITED (AOPL) is an industrial and medical gases company with over 61 years of business experience. Our services include cryogenic supply systems, engineering, construction, installation, training, and maintenance. This is a full-time, on-site role located in Vadodara for a Regulatory Compliance Manager. The...

  • Executive - Regulatory Affairs

    3 weeks ago

    Vadodara, Gujarat, India Sun Pharmaceutical Industries Full time

    Job Title Executive - Regulatory Affairs Business Unit R D1 Regulatory Affairs Job Grade G12A Location Baroda At Sun Pharma we commit to helping you Create your own sunshine - by fostering an environment where you grow at every step take charge of your journey and thrive in a supportive community Are You Ready to Create Your Own Sunshine As...