88 Regulatory Affairs Professional jobs in Mumbai

Job Title: Regulatory Affairs Specialist Med/Pharma (Female)

Location: Remote

Position Overview:

We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines). The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization.

Key Responsibilities:

• Prepared, reviewed, and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
• Ensured compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
• Interacted with regulatory authorities (FDA, EMA, CDSCO, MHRA, Notified Bodies) during product submissions, inspections, and audits.
• Developed and maintained regulatory strategies to support new product development and lifecycle management.
• Reviewed labeling, promotional materials, and product packaging for compliance with applicable regulations.
• Maintained up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
• Supported quality systems in alignment with ISO 13485, ICH, and FDA QSR standards.
• Collaborated with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.
• Assisted in responding to regulatory queries, deficiency letters, and inspection findings.
• Managed regulatory documentation archives and maintained compliance records for audits and inspections.

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Regulatory Affairs Specialist  

POSITION PURPOSE:
• Responsible and accountable for all regulatory affairs activities of Bayer Pharma (PH) within assigned portfolio and/or geography. In alignment with Head of RA PH-South Asia, provide effective functional leadership and governance into planning, developing and executing regulatory strategies within assigned scope, alignment of these with business goals and plans through cross-functional collaboration enabling efficient implementation of growth, brand value
• Scope of regulatory activities includes all licensing related activities (including timely planning and execution of maintenance, change management) for imported products, local products and export markets dealing with the relevant Health Authorities and government bodies in relation to pharmaceuticals (Rx) & medical devices for assigned portfolio and/or geography
• The position will have to consider and balance the business objectives and priorities within assigned portfolio, analyze necessary resource and time allocation, discuss and propose this for alignment with Head of RA PH-South Asia accordingly. The position holder may supervise junior RA staff in managing the Lifecycle Management activities of pharmaceutical portfolio (eg. Renewals, CMCs) when required
• Ensure the best regulatory planning and preparation for all new chemical/biological entities (NCE/NBEs), new indications and line extensions to be registered in the best possible time frame and with the best possible label. Maintains full awareness of all regulatory activities for assigned portfolio and ensures deadlines and performance standards (incl. compliance KPls) are established and met
• Ensure that the assigned portfolio products remain compliant with all relevant regulatory, corporate and legal policies, procedure, practices and local regulations throughout the entire product life cycle. Develop and propose to RA India team standards to monitor and track processes for compliance and governance as best practice sharing for team adoption
• Work closely with relevant local, regional and global stakeholders, cross-functionally and within regulatory affairs, to deliver optimal company outcomes
• Be actively engaged to inspire, motivate, support team members towards functional excellence to meet current and future RA India objectives for assigned portfolio and be seen as value-add business partner
• Ensure maintenance of required licenses for proper functioning of the company, e.g. GMP certificate, manufacturing license (if applicable), special functioning licenses, and provision thereof on request
• To ensure local regulatory processes and procedures reflect current best practice and local regulations
YOUR TASKS AND RESPONSIBILITIES:
• Responsible and accountable for planning, developing and execution of regulatory submissions and approvals in the country for the assigned PH portfolioenabling the achievement of business strategic objectives as well as for ensuring regulatory compliance. Priority setting and flexibility are constantly needed.
• Conduct regulatory probability assessment of approval and HA review milestones to allow optimal business planning
• Operating in a highly regulated environment that is constantly changing, the incumbent provides input and insights for regulatory probability assessments,
anticipating these changes when making probability assessments based on experience and knowledge of the environment
• Within assigned portfolio or projects, build relationships with the Health Authorities and other government bodies, as key customers essential for
achieving business goals. The relationship is based on trust, transparency and partnership
• Maintain compliance with all relevant regulatory requirements with no supply disruption due to lack of regulatory oversight or suboptimal planning
• Supports Head of RA PH-South Asia in development, implementation of processes, SOPs, and systems
• Secure and maintain compliant product licenses, product labelling and participate in promotional material review/approval for products in assigned
portfolio
WHO YOU ARE:
• Post-graduate in Life Sciences (preferably Pharmacy) with minimum of 3 years pharmaceutical industry experience in regulatory affairs with proven track record and experience in health authority interactions and negotiations, end-to-end regulatory submissions and approvals across various therapeutic areas and categories. Demonstrated track record of providing workable solutions to complex regulatory topics.
• In depth understanding of CMC and clinical aspects for regulatory submissions and other licensing requirements in India. Experience with locally manufactured products and export to neighboring countries (eg. Nepal, Bangladesh, Sri Lanka) highly desired
• The successful candidate will have the requisite experience to act as an effective business partner to country commercial organization. Be self-starter with excellent interpersonal and communication skills to facilitate the ability to negotiate and influence others, while dealing with issues which have considerable scientific and regulatory uncertainty
• Have analytical ability to assess complex/ambiguous situations and proactively identify potential issues and future trends and their impact on assigned portfolio. Propose solutions, risk mitigation strategies
• Fluent in English. Excellent communication skills to communicate effectively both orally and in writing to represent Bayer at external meetings and RA India at internal cross-functional and regional/global meetings
• Ability to multi-task without compromising on quality of outcome, compliance. Good project management skills to organize, prioritize and direct diverse activities in a changing environment often under time pressure
• Solid and demonstrated knowledge of all compliance aspects related to the regulatory affairs function, including detailed understanding of the process and policies of the national or agency or extensive experience with a related national health authority
• Global understanding of Regulatory Affairs and India contributes within this. Good working knowledge of regulatory framework in EU, US and International Standards (e.g. ICH, GCP, GMP) highly desired.

Job Title: Regulatory Affairs Specialist Med/Pharma (Female)

Location: Remote

Position Overview:

We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines). The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization.

Key Responsibilities:

• Prepared, reviewed, and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
• Ensured compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
• Interacted with regulatory authorities (FDA, EMA, CDSCO, MHRA, Notified Bodies) during product submissions, inspections, and audits.
• Developed and maintained regulatory strategies to support new product development and lifecycle management.
• Reviewed labeling, promotional materials, and product packaging for compliance with applicable regulations.
• Maintained up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
• Supported quality systems in alignment with ISO 13485, ICH, and FDA QSR standards.
• Collaborated with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.
• Assisted in responding to regulatory queries, deficiency letters, and inspection findings.
• Managed regulatory documentation archives and maintained compliance records for audits and inspections.

Job Title: Regulatory Affairs Specialist Med/Pharma (Female)

Location: Remote

Position Overview:

We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines). The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization.

Key Responsibilities:

• Prepared, reviewed, and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
• Ensured compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
• Interacted with regulatory authorities (FDA, EMA, CDSCO, MHRA, Notified Bodies) during product submissions, inspections, and audits.
• Developed and maintained regulatory strategies to support new product development and lifecycle management.
• Reviewed labeling, promotional materials, and product packaging for compliance with applicable regulations.
• Maintained up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
• Supported quality systems in alignment with ISO 13485, ICH, and FDA QSR standards.
• Collaborated with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.
• Assisted in responding to regulatory queries, deficiency letters, and inspection findings.
• Managed regulatory documentation archives and maintained compliance records for audits and inspections.

Job Title: Regulatory Affairs Specialist Med/Pharma (Female)

Location: Remote

Position Overview:

We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines). The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization.

Key Responsibilities:

• Prepared, reviewed, and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
• Ensured compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
• Interacted with regulatory authorities (FDA, EMA, CDSCO, MHRA, Notified Bodies) during product submissions, inspections, and audits.
• Developed and maintained regulatory strategies to support new product development and lifecycle management.
• Reviewed labeling, promotional materials, and product packaging for compliance with applicable regulations.
• Maintained up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
• Supported quality systems in alignment with ISO 13485, ICH, and FDA QSR standards.
• Collaborated with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.
• Assisted in responding to regulatory queries, deficiency letters, and inspection findings.
• Managed regulatory documentation archives and maintained compliance records for audits and inspections.

Job Title: Regulatory Affairs Specialist Med/Pharma (Female)

Location: Remote

Position Overview:

We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines). The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization.

Key Responsibilities:

• Prepared, reviewed, and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
• Ensured compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
• Interacted with regulatory authorities (FDA, EMA, CDSCO, MHRA, Notified Bodies) during product submissions, inspections, and audits.
• Developed and maintained regulatory strategies to support new product development and lifecycle management.
• Reviewed labeling, promotional materials, and product packaging for compliance with applicable regulations.
• Maintained up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
• Supported quality systems in alignment with ISO 13485, ICH, and FDA QSR standards.
• Collaborated with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.
• Assisted in responding to regulatory queries, deficiency letters, and inspection findings.
• Managed regulatory documentation archives and maintained compliance records for audits and inspections.

The Regulatory Compliance Specialist is a key position in the Regulatory Compliance organization. This position drives the daily compliance activities required under the company's trade compliance policy. The Regulatory Compliance Specialist is primarily responsible for resolving potential DPL matches and work with stakeholders that these are not exact matches. This position also reviews compliance holds relative to strategic or controlled goods and based on the nature of end-customers, determines whether a license or government authorization is required to make the sale or the export. This position is involved in conducting risk assessment of end-customers and categorize them accordingly based on a defined criterion. The Regulatory Compliance Specialist is responsible for analyzing metrics that track turnaround times in reviewing and releasing DPC and ECCN holds. Minimum supervision is required for this role.

• Address DPC escalations relating to potential matches when screening new customers, vendors or subcons.

• Assist in determining the in-country HS codes for articles created in SAP system.

• Perform ECCN review and determine license/regulatory requirements for all sales transactions.

• Extract report from SAP system for DPC and ECCN Hold Metrics per month. Analyze metrics & determine actions further improve turnaround time or reduce DPC holds.

• Prepare other trade compliance reports as required by the department.

• Perform risk assessments on end-customers and categorize them according to a pre-determined criterion.

• Perform ECCN validation of new articles created in SAP.

Knowledge, Skills and Experience:

• 3 to 5 Years of relevant work experience.

• Associate degree with International Trade or Logistics field of study required.

• Minimum Diploma in International Trade or Logistics or Supply Chain

• Able to execute instructions and to request clarification when needed.

• Able to use a 10-key quickly and accurately.

• Possesses basic clerical and data entry skills.

• Possesses strong data entry skills.

• Able to recognize and attend to important details with accuracy and efficiency.

• Able to communicate clearly and convey necessary information.

• Able to converse and write effectively in English.

• Possesses strong multi-cultural interpersonal skills.

• Able to constructively work under stress and pressure when faced with high workloads and deadlines.

• Able to maintain and promote social, ethical, and organizational standards in conducting internal and external business activities.

• Able to work independently with minimum supervision.

• Able to maintain confidentiality of sensitive information.

• Able to build solid, effective working relationships with others.

• Able to exhibit ability to be sensitive to the needs, concerns, and feelings of others.

• Able to quickly learn new systems and technology.

• Consistent non-standard work or overtime as business requires.

• On-call availability required as necessary.

• Professional, office environment.

• Full-time working week with some work hours flexibility expected.

What’s In It For You?

• Elective Benefits: Our programs are tailored to your country to best accommodate your lifestyle.
• Grow Your Career: Accelerate your path to success (and keep up with the future) with formal programs on leadership and professional development, and many more on-demand courses.
• Elevate Your Personal Well-Being: Boost your financial, physical, and mental well-being through seminars, events, and our global Life Empowerment Assistance Program.
• Diversity, Equity & Inclusion: It’s not just a phrase to us; valuing every voice is how we succeed. Join us in celebrating our global diversity through inclusive education, meaningful peer-to-peer conversations, and equitable growth and development opportunities.
• Make the Most of our Global Organization : Network with other new co-workers within your first 30 days through our onboarding program.
• Connect with Your Community: Participate in internal, peer-led inclusive communities and activities, including business resource groups, local volunteering events, and more environmental and social initiatives.

• Develop and implement regulatory strategies for new and existing pharmaceutical products.
• Prepare, review, and submit regulatory dossiers (e.g., CTD, ANDA) to health authorities.
• Liaise with regulatory agencies (e.g., FDA, EMA, CDSCO) to facilitate product approvals.
• Ensure all regulatory activities comply with relevant guidelines and regulations.
• Provide regulatory guidance and support to R&D, manufacturing, and marketing teams.
• Monitor changes in the regulatory landscape and assess their impact on the company.
• Manage post-approval regulatory submissions and lifecycle management.
• Review promotional materials and labeling for regulatory compliance.
• Conduct regulatory due diligence for potential partnerships and acquisitions.
• Maintain regulatory documentation and databases.

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
• 5+ years of experience in pharmaceutical regulatory affairs.
• In-depth knowledge of global pharmaceutical regulations and submission processes.
• Proven experience in preparing and submitting regulatory dossiers.
• Familiarity with drug development lifecycle and manufacturing processes.
• Excellent written and verbal communication skills.
• Strong analytical and problem-solving abilities.
• Ability to manage multiple projects and prioritize effectively.
• Proficiency in regulatory information management systems is a plus.
• Experience working with international health authorities.