74 Regulatory Affairs Specialist jobs in Hyderabad

Job Description of Regulatory Project Management Candidate:

1. The primary responsibilities will involve supporting Regulatory Affairs (RA) activities for nutraceutical products.
2. Arranging the Legal Documents (POAs, LOAs) and Apostillizations & Sending hard copies to country teams.
3. Arranging Admin documents (GMP,COPP & FSC) and Apostillizations & sending hard copies to country teams (Co-ordination with HO team).
4. Arranging the Technical documents like Qualitative & Quantitively (Q&Q documents) with co-ordination of RA team and getting them Apostilled and sending the hard copies to Country teams.
5. Co-Ordinating with Legal teams, SCM(Ref stds/RLDs) and IT(Zoho aspects) teams to extend the support from HO to countries.
6. Co-Ordinating with Marketing / Regulatory service providers based at Latin America in regulatory support aspects from HO.
7. Co-Ordinating with IP teams based at R&D in patient related aspects in Emerging markets countries & Co-ordination with Portfolio teams at HO in PEF & PIF aspects.
8. Co-Ordination with R&D PM team's in DPDM&CDP analysis and arranging the required support from HO.
9. Arranging the FP samples from Plants and other required documents to Countries for Dossier Submissions.
10. Arranging the Analytical Pre-Requisites to Countries as per the requirement by Coordinating with Plant QC/QA.

Qualification & Experience

• Education : LLB from a reputed law college (preferably Symbiosis or NLUs)
• Experience : Minimum 1-3 years of experience in compliance, legal, or regulatory functions

Key Responsibilities

1. Provide timely compliance support to business teams for the organization’s compliance application (tool).
2. Monitor legal and regulatory amendments that impact the organization and promptly inform relevant stakeholders.
3. Prepare compliance reports and dashboards as per the organization’s Compliance Policy.
4. Works related to Ethics & Compliance for better implementation of Anti bribery and Anti Corruption Policy, Whistle blower, policy and Code of Business ethics of the Company.
5. Conduct compliance audits through visits to company sites and projects;
   identify, document, andreport non-compliances to management.
6. Assist in planning and conducting compliance trainings and provide handholding support to business teams.
7. Maintain and regularly update the license tracker for all business projects.
8. Work towards achieving assigned Key Result Areas (KRAs) and performance metrics.
9. Ensure timely completion of compliance tasks with accuracy and high-quality deliverables.

Key Skills & Competencies

• Strong understanding of corporate legal and regulatory compliance requirements
• Excellent analytical and problem-solving skills
• Strong communication and stakeholder management abilities
• Proficiency in compliance management tools and MS Office applications
• Ability to work independently as well as collaboratively with cross-functional teams
• High level of integrity, accountability, and attention to detail

About the Role

We are looking for a Medical Device Regulatory Lead with 4–6 years of proven hands-on experience in medical device regulatory submissions and compliance. The ideal candidate will have strong expertise in preparing and submitting applications to Health Authorities including US FDA (510k), Europe (CE Marking), MDSAP, CDSCO , and other global regulatory agencies. This role requires leadership, ownership, and the ability to guide cross-functional teams through complex regulatory pathways.

Key Responsibilities

• Lead the preparation, submission, and management of medical device applications (US FDA 510k, CE Marking, MDSAP, CDSCO, and other markets).
• Ensure compliance with regulatory standards including ISO 13485, 21 CFR 820 , and other applicable regulations.
• Act as the primary contact for Health Authorities, managing queries and responses effectively.
• Oversee regulatory strategy, project planning, and execution for medical device submissions.
• Provide guidance on Quality Management Systems (QMS) and support audits/inspections.
• Collaborate with cross-functional teams (R&D, Quality, Manufacturing, Clinical, Commercial) to align regulatory requirements with business objectives.
• Take ownership of projects, demonstrating leadership and accountability in delivery.

Qualifications

• 4–6 years of experience in medical device regulatory affairs .
• Proven track record with submissions to FDA (510k), CE Marking, CDSCO, and other agencies .
• Strong knowledge of ISO 13485, 21 CFR 820, QMS practices, and international medical device regulations .
• Experience in responding to Health Authority queries and managing regulatory communications.
• Excellent project management, organizational, and leadership skills.
• Ability to work independently, take ownership, and drive results.

Why Join Us

• Opportunity to lead regulatory projects across global markets.
• Work in a dynamic, entrepreneurial, and collaborative environment.
• Be at the forefront of advancing compliance and patient safety in medical devices.
• Apply now via LinkedIn or connect with us to explore this opportunity

Company Overview

Gamut HR Solutions is dedicated to helping individuals find the right job opportunities effectively and efficiently. With a small yet dynamic team located in Hyderabad, we strive to connect talented professionals with companies in need of their expertise. Visit our website at to learn more about how we can assist in your career advancement.

Job Overview

We are seeking a dedicated Regulatory Affairs Specialist - Pharma to join our team in Hyderabad. This is a full-time, junior-level position designed for candidates with 1 to 3 years of experience. The chosen candidate will be responsible for a variety of regulatory procedures, ensuring compliance and managing strategic regulatory projects within the pharmaceutical sector.

Qualifications and Skills

• Proficient in FDA regulatory submissions, crucial for the timely approval of products (Mandatory skill).
• Skilled in risk management processes, necessary to identify, assess, and prioritize regulatory risks (Mandatory skill).
• Adept at regulatory strategy development to efficiently navigate and comply with complex regulations (Mandatory skill).
• Solid understanding of EU MDR compliance to ensure product safety and efficacy.
• Experience with quality management systems, enabling efficient organization and processes for regulatory compliance.
• Knowledge of ISO 13485 standards for designing and manufacturing medical devices.
• Competency in labeling and documentation review to ensure accuracy and regulatory compliance.
• Experience in product lifecycle management to oversee the entire regulatory process from development to post-market.

Roles and Responsibilities

• Preparing and submitting regulatory documents to ensure compliance with regional and international regulatory requirements.
• Collaborating with cross-functional teams to support regulatory strategies and submissions.
• Conducting risk assessments and implementing risk mitigation strategies.
• Maintaining up-to-date knowledge of regulatory legislation, guidelines, and standards.
• Reviewing and approving labeling, promotional, and support materials.
• Managing timelines and delivering high-quality regulatory submissions within set deadlines.
• Providing regulatory input for new product development and design changes.
• Participating in regulatory inspections and audits as required.

• Develop and implement regulatory strategies for new drug applications and product lifecycle management.
• Prepare, review, and submit regulatory dossiers to health authorities in India and other key markets (e.g., US, EU).
• Liaise directly with regulatory agencies to address queries and facilitate timely approvals.
• Ensure compliance with ICH guidelines, GMP, GCP, and other relevant regulations.
• Evaluate regulatory impact of changes in manufacturing processes, labeling, and product specifications.
• Provide regulatory guidance and support to cross-functional teams (R&D, QA, Manufacturing, Marketing).
• Maintain regulatory filings and ensure timely updates and renewals.
• Monitor and analyze regulatory intelligence and trends in the pharmaceutical industry.
• Participate in regulatory inspections and audits.
• Contribute to the development of regulatory policies and procedures.

• Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field; advanced degree (Ph.D. or Pharm.D.) is a plus.
• Minimum of 6 years of experience in regulatory affairs within the pharmaceutical industry.
• In-depth knowledge of pharmaceutical regulatory requirements in India (CDSCO) and major international markets (FDA, EMA).
• Proven experience in preparing and submitting various types of regulatory applications (e.g., ANDA, NDA, variations).
• Excellent scientific writing, communication, and analytical skills.
• Strong understanding of drug development processes, manufacturing, and quality systems.
• Ability to interpret and apply complex regulatory guidelines.
• Proficiency in regulatory information management systems.
• Strong project management and organizational skills.
• Ability to work independently and collaboratively in a team-oriented environment.

• Monitor and interpret aviation regulations from various national and international authorities (e.g., DGCA, FAA, EASA).
• Assess the impact of regulatory changes on company products, operations, and policies.
• Develop and implement strategies to ensure ongoing compliance with all applicable aviation laws and standards.
• Prepare, review, and submit regulatory documentation, applications, and filings.
• Manage certification processes for aircraft, components, or operational approvals.
• Liaise with aviation authorities to facilitate approvals, certifications, and inspections.
• Provide expert regulatory advice and support to internal departments, including engineering, design, and operations.
• Conduct regulatory training sessions for relevant personnel.
• Maintain comprehensive records of all regulatory submissions and approvals.
• Contribute to the development of company policies and procedures to align with regulatory requirements.

• Bachelor's degree in Aviation Law, Aerospace Engineering, Public Administration, or a related field. A Master's degree is a plus.
• Minimum of 7 years of experience in aviation regulatory affairs, compliance, or a related field.
• In-depth knowledge of global aviation regulations and certification processes.
• Proven experience in managing regulatory submissions and interactions with aviation authorities.
• Strong research, analytical, and problem-solving skills.
• Excellent written and verbal communication skills, with the ability to explain complex regulatory requirements clearly.
• Experience working effectively in a remote and collaborative team environment.
• Ability to manage multiple complex projects simultaneously.
• Proficiency in relevant software and databases for regulatory tracking and management.

About the Role:

We are seeking a Regulatory & Compliance Specialist on a contract basis to support our compliance requirements in India and international destination countries. This role is ideal for professionals experienced in handling regulatory filings, certifications, and export-related compliance in pharma, Ayurveda, nutraceuticals, or cosmetics.

Key Responsibilities:

• Apply for and renew licenses and certifications such as FSSAI, AYUSH, GMP, Organic, COSMOS as required.
• Arrange phytosanitary inspections and coordinate with laboratories and quarantine officers.
• Provide guidance on country-specific product classification (e.g., cosmetic vs. medicine).
• Maintain a compliance tracker for each product and destination country.
• Ensure smooth coordination with government departments, regulatory authorities, and testing labs.

Requirements:

• 3–6 years of experience in regulatory affairs, preferably in pharma, Ayurveda, or export compliance .
• Strong understanding of regulatory filings for African/CIS countries (preferred).
• Ability to work remotely and independently while managing communication with labs, certification bodies, and government departments.
• Excellent organizational and documentation skills.

About the Role:

We are seeking a Regulatory & Compliance Specialist on a contract basis to support our compliance requirements in India and international destination countries. This role is ideal for professionals experienced in handling regulatory filings, certifications, and export-related compliance in pharma, Ayurveda, nutraceuticals, or cosmetics.

Key Responsibilities:

• Apply for and renew licenses and certifications such as FSSAI, AYUSH, GMP, Organic, COSMOS as required.
• Arrange phytosanitary inspections and coordinate with laboratories and quarantine officers.
• Provide guidance on country-specific product classification (e.g., cosmetic vs. medicine).
• Maintain a compliance tracker for each product and destination country.
• Ensure smooth coordination with government departments, regulatory authorities, and testing labs.

Requirements:

• 3–6 years of experience in regulatory affairs, preferably in pharma, Ayurveda, or export compliance .
• Strong understanding of regulatory filings for African/CIS countries (preferred).
• Ability to work remotely and independently while managing communication with labs, certification bodies, and government departments.
• Excellent organizational and documentation skills.

About the Role:

We are seeking a Regulatory & Compliance Specialist on a contract basis to support our compliance requirements in India and international destination countries. This role is ideal for professionals experienced in handling regulatory filings, certifications, and export-related compliance in pharma, Ayurveda, nutraceuticals, or cosmetics.

Key Responsibilities:

• Apply for and renew licenses and certifications such as FSSAI, AYUSH, GMP, Organic, COSMOS as required.
• Arrange phytosanitary inspections and coordinate with laboratories and quarantine officers.
• Provide guidance on country-specific product classification (e.g., cosmetic vs. medicine).
• Maintain a compliance tracker for each product and destination country.
• Ensure smooth coordination with government departments, regulatory authorities, and testing labs.

Requirements:

• 3–6 years of experience in regulatory affairs, preferably in pharma, Ayurveda, or export compliance .
• Strong understanding of regulatory filings for African/CIS countries (preferred).
• Ability to work remotely and independently while managing communication with labs, certification bodies, and government departments.
• Excellent organizational and documentation skills.