Regulatory Affairs

18 hours ago

Ahmedabad, India Lendex Technology Full time ₹ 12,00,000 - ₹ 30,00,000 per year

Responsibilities:

Dossier Preparation:

  • Compile, review, and prepare regulatory documentation, ensuring accuracy and completeness.
  • Collaborate with cross-functional teams to gather necessary information for dossier submissions.
  • Maintain and update regulatory files and databases.
     

DMF Management:

  • Manage Drug Master Files (DMFs) and ensure timely submissions to regulatory authorities.
  • Liaise with internal teams and external partners to obtain required information for DMF updates.
  • Monitor DMF compliance and address any deficiencies in collaboration with relevant stakeholders.
     

Compliance Oversight:

  • Stay abreast of regulatory changes and updates, ensuring the organization's compliance with industry standards.
  • Conduct internal audits to assess compliance with regulatory requirements.
  • Develop and implement strategies to address and rectify compliance issues.
     

Qualifications:

Education:

  • Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field.

Experience:

  • Minimum of 4-7 years of experience in regulatory affairs within the pharmaceutical or related industry.
  • Proven track record of successful dossier preparation and submission.
     

Key Skills:

  • In-depth knowledge of Drug Master Files (DMFs) and regulatory requirements.
  • Strong understanding of compliance principles and practices.
  • Excellent analytical and problem-solving skills.
  • Attention to detail and ability to manage multiple tasks simultaneously.
  • Effective communication and interpersonal skills for collaboration with internal and external stakeholders.
     

What We Are Looking For:

  • A candidate with a keen understanding of regulatory affairs and the ability to navigate complex regulatory landscapes.
  • Someone who can take ownership of DMF filing management and demonstrate a proactive approach to compliance.
  • Strong organizational skills and attention to detail are crucial for success in this role.
  • The ideal candidate should be a team player with excellent communication skills, capable of fostering collaboration across departments.
  • Ability to adapt to changes in regulatory requirements and implement strategies to ensure ongoing compliance.
     

Join our team and be a vital part of ensuring regulatory excellence in the pharmaceutical industry

  • Regulatory Affairs

    22 hours ago

    Ahmedabad, India Lendex Technology Full time ₹ 8,00,000 - ₹ 12,00,000

    Responsibilities: Dossier Preparation: Compile, review, and prepare regulatory documentation, ensuring accuracy and completeness.Collaborate with cross-functional teams to gather necessary information for dossier submissions.Maintain and update regulatory files and databases.  DMF Management: Manage Drug Master Files (DMFs) and ensure timely submissions to...

  • Regulatory Affairs

    7 days ago

    Ahmedabad, Gujarat, India Medipharma Konnect Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    We are hiring Regulatory Affairs (RA) Executive / Manager for a leading Pharma company in Ahmedabad. The candidate will be responsible for dossier preparation, product registration, regulatory submissions, and maintaining compliance with international guidelines (ROW / LATAM / Africa). Must have hands-on experience in RA documentation for pharma...

  • Regulatory Affairs Executive

    4 days ago

    Ahmedabad, India BKM Health Pvt Ltd Full time

    Regulatory Affairs Executive :(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...

  • Regulatory Affairs Executive

    4 days ago

    Ahmedabad, India BKM Health Pvt Ltd Full time

    Regulatory Affairs Executive :(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...

  • Regulatory Affairs Executive

    4 days ago

    Ahmedabad, India BKM Health Pvt Ltd Full time

    Regulatory Affairs Executive :(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...

  • Regulatory Affairs Executive

    3 days ago

    Ahmedabad, India BKM Health Pvt Ltd Full time

    Regulatory Affairs Executive :(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...

  • Regulatory Affairs Executive

    4 days ago

    Ahmedabad, India BKM Health Pvt Ltd Full time

    Regulatory Affairs Executive : (BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...

  • Regulatory affairs executive

    3 days ago

    Ahmedabad, India BKM Health Pvt Ltd Full time

    Regulatory Affairs Executive :(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, e CTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...

  • Regulatory Affairs Executive

    3 days ago

    Ahmedabad, India BKM Health Pvt Ltd Full time

    Regulatory Affairs Executive : (BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...

  • Regulatory affairs executive

    2 days ago

    Ahmedabad, India BKM Health Pvt Ltd Full time

    Regulatory Affairs Executive :(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, e CTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...