Regulatory Affairs Specialist

14 hours ago


Bangalore, India Biocon Biologics Full time

Position Summary

The Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations in emerging markets. Key Activities required for this job are as below

• Develop and implement regulatory strategies for biosimilar products in LATAM.

• Prepare, review, and submit dossiers for marketing authorization applications (MAAs), renewals, and variations in compliance with local requirements.

• Ensure adherence to regional regulatory reuqirements

• Evaluate and implement regulatory changes impacting product lifecycle.

• Manage post-approval activities including labeling updates, renewals, and change control assessments.

• Ensure compliance with regional regulations and company SOPs.

• Maintain up-to-date knowledge of LATAM regulatory guidelines, including Module 1 (m1) requirements for submissions.

• Liaise with local health authorities, business partners, and internal teams (CMC, QA, PV, Medical Affairs).

• Support agency meeting preparations and GMP certification processes.

• Assess regulatory impact of manufacturing and quality changes.

• Define submission plans and timelines for change control activities.

• Hands-on experience with biosimilars submission.

Experience:

Minimum 4 years in Regulatory Affairs within the pharmaceutical/biotech industry



  • Hyderabad, Telangana Bangalore, Karnataka, India beBeePublishing Full time ₹ 1,20,00,000 - ₹ 2,00,00,000

    Regulatory Affairs Publishing AssociateThis role is ideal for a highly skilled and experienced Regulatory Affairs professional who has expertise in regulatory publishing, document management, and stakeholder engagement. As a Regulatory Affairs Publishing Associate, you will play a key role in supporting global regulatory submission activities by managing...


  • Bangalore, India Halma plc Full time

    About Halma: Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US. Our diverse group of nearly 50 global companies specialize in market leading technologies that push the...


  • Bangalore, India Biocon Biologics Full time

    We are looking for a Regulatory Affairs professional with hands-on experience in biologics/biosimilars registration across Emerging Markets (Middle East, Asia, LATAM, Africa, CIS) regions. The candidate will be responsible for preparing and managing regulatory submissions, tracking country-specific requirements, and coordinating with local affiliates,...


  • Bengaluru / Bangalore, Chennai, India beBeeOncology Full time US$ 90,000 - US$ 1,20,000

    Establish a leadership position in oncology medical affairs by driving scientific and technical initiatives that advance the company's objectives.Key Responsibilities:Represent the company as a subject matter expert in oncology, fostering credible relationships with external experts and healthcare professionals.Develop and execute strategic plans for...


  • Bengaluru / Bangalore, Chennai, Ahmedabad, India beBeeCompliance Full time US$ 90,000 - US$ 1,20,000

    Compliance Excellence SpecialistWe are seeking a highly skilled Compliance Excellence Specialist to join our team. This is an exciting opportunity to contribute to the success of our organization by ensuring the highest standards of compliance and quality assurance.Key Responsibilities:Conduct thorough assessments of alerts, escalations, and investigations...

  • Associate Iii

    1 week ago


    Hyderabad, Telangana Bangalore, Karnataka, India UST Full time

    Associate III - Business Analysis Regulatory Affairs - Life Sciences Publishing Role Summary The Associate III - Business Analyst Regulatory Affairs - Publishing plays a crucial role in supporting regulatory operations within the life sciences industry This role involves understanding stakeholder needs gathering and analyzing requirements and...

  • PR & communication

    14 hours ago


    Bangalore, India Ola Full time

    About the Role We’re looking for a PR & communications leader who can shape how Ola is seen by the world. If you’ve spent a decade building media relationships, leading teams, and managing high-stakes communication, this role puts you at the center of conversations in mobility, policy, and public perception. What You’ll Do Lead the...

  • Policy Manager

    14 hours ago


    Bangalore, India slice Full time

    Our Public Policy team plays a critical role in navigating the regulatory environment and ensuring alignment with slice’s business goals within India’s policy framework. This team works closely with government bodies, regulatory departments and other relevant stakeholders to achieve slice’s objectives. Provide direction and guidance on policy...

  • Lead I

    1 week ago


    Hyderabad, Telangana Bangalore, Karnataka, India UST Full time

    Job Title Life Sciences Regulatory Affairs RA Associate - Publishing Job Summary We are looking for a skilled and experienced Regulatory Affairs Associate - Publishing to join our Life Sciences Practice The ideal candidate will support global regulatory submission activities by managing electronic publishing document-level and submission-level ...

  • Public Policy Manager

    14 hours ago


    Bangalore, India slice Full time

    About the team Our Public Policy team plays a critical role in navigating the regulatory environment and ensuring alignment with slice’s business goals within India’s policy framework. This team works closely with government bodies, regulatory departments and other relevant stakeholders to achieve slice’s objectives. By leading our engagement...