15 Product Registration Jobs

Dossier Preparation & Compilation: Lead the preparation, review, and submission of regulatory dossiers in CTD, ACTD, and eCTD formats for global markets, ensuring adherence to country-specific regulations. Regulatory Strategy & Market Compliance: Develop and implement regulatory strategies for product approvals across ROW, LATAM, SEA, Africa, and Pacific regions. Bioequivalence Studies & Compliance: Coordinate with CROs to ensure compliance and timely approval of bioequivalence studies for international submissions. Product Lifecycle Management: Oversee regulatory activities throughout the product lifecycle including renewals, variations, and post-marketing compliance. Product Registration & Market Expansion: Handle product registration processes, liaise with authorities, and ensure smooth approvals in targeted regions. Technical File Review: Review technical documentation to ensure accuracy and completeness for regulatory filings. Regulatory Compliance & Audits: Ensure compliance with country-specific guidelines including WHO-GMP, ICH, and other global standards. Regulatory Documentation & Reporting: Maintain accurate and updated regulatory records and provide timely reports to senior leadership. Stakeholder Management: Act as the key liaison between regulatory bodies, internal departments, and external partners. Process Improvement & Team Leadership: Mentor junior team memb

Objectives Of The Position Responsible for Regulatory strategy of South Asia, ASEAN, ANZ (close collaboration with strategic Regulatory management team) Responsible for all compliance activities in South Asia, ASEAN, ANZ Responsible for all registration activities in South Asia, ASEAN, ANZ Consolidate and communicate prioritization of product registrations and regulatory submissions Provide customer support beyond BASF for end users, supporting customers in preparation of drug product submissions and responses to deficiency questions from Health authorities Consolidate and communicate development in the South Asia, ASEAN, ANZ regulatory environment Regulatory representative for BASF Pharma in South Asia, ASEAN, ANZ Main Areas If Responsibility And Key Activities Regulatory Prepare and compile the checklist and documents for Active Ingredients, New application and renewal applications; Coordinate with global and regional regulatory on strategizing the approach for new and renewal application submission, authority deficiency questions and post approval variations Coordinate with global and regional regulatory for regulatory/quality documents support for customer requests Understand the gaps on the analytical questions from customers and provide interim or immediate support Establish an overview on upcoming and updated regulatory guidelines and identify the top focus topics for South Asia, ASEAN, ANZ Actively participate in the Regulatory process including monthly/ quarterly country calls, regional reporting and Global RA meetings Customer support Provide complete and timely support to internal and external customers on regulatory matters Industry representation Represent BASF Pharma at South Asia Pharma/Excipients associations (e-g IPEC India) Others Engage with South Asia sales head and sales colleagues to understand the business needs and potential Job Requirements Minimum Bachelor Degree in Science/ Pharmacy Minimum 5 years of regulatory and quality experience in pharmaceutical industry Understand India regulatory and US FDA guidelines Prior experiences in Regulatory Affairs/ Quality Control laboratory Team player with strong communication skills Can speak English and Hindi (preferred)

About Zydus Wellness Zydus Wellness, an FMCG leader, develops, manufactures, and markets health and wellness products, integrating healthcare, skincare, and nutrition. Founded in 1988 with Sugar Free, India’s first zero-calorie sugar replacement, it now manages seven global brands, including Complan, Glucon-D, Everyuth, and Nutralite. The company serves over 50 million families and supports more than 90,000 dairy farmers and 2,000 MSMEs. With a focus on research, quality, and innovation, Zydus Wellness operates on core pillars of manufacturing integrity and supply chain efficiency. Headquartered in Ahmedabad and Mumbai, it runs four manufacturing facilities across India and eight co-packing facilities in India, Oman, and New Zealand. Listed on the Bombay and National Stock Exchanges, Zydus Wellness is led by Chairman Dr. Sharvil Patel and CEO Tarun Arora, serving customers in over 25 countries across three continents. S. No Get to know our organization – Click on the below links 1 Company Website 2 Zydus Corporate Park Job Title: Assistant Manager - Food Regulatory Affairs Location: Ahmedabad- ZCP, Gujarat, India Department: Regulatory Affairs Functional Reporting: Manager Regulatory Affairs Administrative Reporting: Manager Regulatory Affairs Job Type: Full-time Role: Responsible for ensuring compliance with all food safety and regulatory requirements for the organization’s products. This role involves supporting the preparation, submission, and maintenance of regulatory documents and licenses, coordinating with internal and external stakeholders, and staying updated with evolving food regulations. The incumbent will play a key role in safeguarding the company’s regulatory standing and facilitating market access for new and existing products Key Responsibilities: Regulatory Compliance Management: Ensure compliance with food safety laws, regulations, and standards (e.g., FSSAI regulations, BIS standards, etc.) in India. Monitor regulatory changes and assess their impact on company operations. Liaise with internal teams (R&D, Quality Assurance, Marketing, Legal) to ensure that new products meet regulatory requirements. FSSAI & Legal Documentation: Assist in obtaining and renewing relevant licenses, registrations, and certifications from regulatory authorities such as FSSAI, LM, and other local bodies. Prepare, review, and maintain regulatory documentation and product dossiers for submission to relevant authorities. Work on product labeling, claims, and packaging to ensure compliance with the Food Safety and Standards Act. Risk Assessment and Management: Evaluate potential risks related to food safety, labeling, and regulatory compliance, and propose corrective measures. Conduct risk analysis on new and existing food products to mitigate any potential non-compliance. 4. Financial Support the cost-effective management of regulatory submissions and compliance-related activities 5. Customer Ensure timely and accurate submissions to regulatory authorities to meet business timelines. Address regulatory queries and facilitate smooth approval processes for product registrations 6. Process Prepare, review, and submit regulatory documents, product dossiers, and compliance reports. Maintain regulatory records, databases, and ensure up-to-date documentation. Monitor and interpret changes in food safety regulations and communicate impact to internal stakeholders. Coordinate with R&D, Quality, and Production teams to ensure compliance of product formulations and labeling with regulatory requirements 7. People Collaborate with cross-functional teams to align regulatory activities with business objectives Develop strong working relationships with external regulatory bodies and industry association Key Deliverables Timely submission and approval of regulatory filings for new and existing products. Maintenance of accurate regulatory documentation and compliance databases. Proactive identification and communication of regulatory changes impacting business operations. Key Requirements: Educational Qualification Master’s degree in Dairy Technology or Dairy Sciences (Preference NDRI- Karnal) Additional certification or training in regulatory affairs is a plus. Experience: 1-3 years of experience in regulatory affairs, specifically related to food(Dairy) regulatory and compliance in India. Experience in preparing and handling regulatory submissions, licenses, and compliance documentation Knowledge of food safety regulations and industry standards in India. Skills and Competencies: In-depth knowledge of FSSAI regulations, food safety laws, and compliance requirements in India. Knowledge of national and international food regulations and standards (e.g., FSSAI, Codex) Expertise in regulatory documentation, labeling compliance, and product registrations Familiarity with food safety systems and quality management practices Strong written and verbal communication skills. Attention to detail with the ability to manage multiple projects simultaneously. Strong analytical and problem-solving skills. Ability to work cross-functionally with internal teams and regulatory authorities. Personal Attributes: Proactive and self-driven with the ability to work independently. Strong organizational skills with the ability to prioritize tasks effectively. Ability to maintain confidentiality and handle sensitive information with discretion. Behavioral Competencies Zydus Neev Behavioural Competency Framework Clear and concise communication skills to convey complex regulatory requirements Strong interpersonal skills to work with cross-functional teams and external authorities Meticulous approach to maintaining regulatory documentation and ensuring compliance

Role & responsibilities Oversee and manage the preparation, submission, and tracking of regulatory dossiers for product registrations, renewals, and variations across Asia, including but not limited to ASEAN, South Asia, East Asia, and Middle East regions. Conduct thorough regulatory reviews of dossier sections (Quality) to ensure alignment with country-specific requirements and ICH guidelines. Coordinate with internal teams RA(CMC), QA, Manufacturing, Clinical Affairs, Local (country specific) and external stakeholders to ensure timely and accurate submissions. Manage regulatory responses to queries and deficiency letters from health authorities and clients, ensuring resolution within timelines. Assess the regulatory impact of proposed post-approval changes and support change control documentation and implementation. Lead lifecycle management activities for approved products, including renewals, variations, labeling updates, and market expansions. Prepare regulatory documents for GMP inspections, tender submissions, and related regulatory filings. Stay updated with regional regulatory developments, including changes in biopharmaceutical regulations and evolving health authority expectations. Provide regulatory guidance on labeling and artwork to ensure compliance with country-specific labeling requirements. Maintain and update regulatory trackers, databases, and dashboards to monitor project status and deadlines. Support the development of regulatory strategies for new product launches and geographic expansion within Asia. Ensure compliance with global and local regulatory SOPs and documentation standards.

Do you want to contribute to the future of healthcareAs Siemens Healthineers values those who dedicate their energy and passion to this cause, our company’s name is dedicated to our employees. It’s their pioneering spirit, blended with our long history of engineering in the ever-evolving healthcare industry that truly makes us unique as an employer. We offer you a flexible and dynamic environment and the space to stretch beyond your comfort zone to grow both personally and professionally. Sound interesting Then come in and join India team as Regulatory Affairs Specialist. Your tasks and responsibilities: Planning and preparing product related medical device submissions for the products manufactured at the Bangalore factory according to country specific regulatory requirements and maintaining of licensed products (e.g., for USA, EU, India, Latin America, Asia) Take responsibility for product / component registrations following respective standards such as BIS, AERB, CDSCO for the products used at the Bangalore factory You will provide professional advice to and actively support internal departments, such as product development in implementation and fulfillment of the applicable regulatory requirements (laws, guidelines, regulations) to ensure the registration of the products manufactured. Supporting the audits from the respective authorities of the different countries as a part of the product registration process Your qualifications and experience: You have a diploma or degree in engineering, or a comparable field of study with relevant knowledge of imaging procedures (e.g., radiography, fluoroscopy) and clinical interventional procedures You have 4-5 yrs of experience in medical device registration. You have knowledge of the pertinent regulatory frameworks of the EU, China, India, and Latin America. Experience regarding USA registrations would be beneficial You have professional experience in the regulatory affairs functions or in comparable positions in the medical device industry, and you are very familiar with relevant interfacing processes, such as product risk management, post-market surveillance, and product lifecycle management Your attributes and skills: You show a collaborative, inspiring working style, and you can accommodate different personalities in a functional team You have excellent written and spoken English communication skills You are a great communicator, collaborative, inspiring, and able to accommodate different personalities in a functional team You are experienced in working in a demanding environment, and you pursue the aligned strategic targets by prioritization, consolidation, and smart decision making We win togetheryou are a team player; you follow the Siemens Healthineers goals with dedication and passion for the job Our global team: We are a team of 68,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways. Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Click here to get started. To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our job’s alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.

Manage all the business discussion and relationship with existing customers Conduct internal and external analysis on customer’s business Communicate effectively with the client and respond to complex queries with regards to contract obligation Required Candidate profile • Ability to effectively participate in cross functional commercial teams and present results/recommendations to stakeholders and management at plant sites and headquarters when necessary

1. Regulatory Submissions: Preparation and compilation of dossiers in CTD/eCTD formats for domestic and international markets (ROW countries). Submission of registration applications for new products and variations (post-approval changes). 2. Documentation: Review and verification of technical documents such as Product Information Leaflets, Labels, SPC, COAs, Stability Data, Product Development Reports, etc. Coordination with R&D, QA, QC, and production teams for required documents and data. 3. Regulatory Compliance: Ensure products and documentation comply with applicable regulations and guidelines (ICH, WHO, FDA, EMA, CDSCO, etc.). Monitor regulatory changes and ensure timely updates to internal systems and processes. 4. Product Lifecycle Management: Handle renewals, variations, and responses to regulatory queries/deficiencies. Maintain product registration databases and archival of regulatory submissions. 5. Liaison & Communication: Coordinate with regulatory authorities, agents, and external consultants as required. Attend audits and respond to regulatory inspections

Roles & Responsibilities: 1. Product Registration: Handle the registration of products under FDCA (Food and Drugs Control Administration) for necessary approvals. 2. Label Claim Verification: Coordinate with the Formulation & Development team to confirm and validate claims mentioned on product labels and the regulatory classification of each product. 3. Artwork Coordination: Work closely with the sales team to ensure that product artworks (for existing and new products) meet all relevant regulatory requirements. 4. Renewals & Compliance: Manage the timely renewal of product approvals under applicable regulatory bodies, maintaining full compliance throughout the product lifecycle. Qualifications: 1. Bachelors or master’s degree in pharmacy , chemistry, or a related field. 2. 1–2 years of experience in regulatory affairs (preferably in cosmetics, personal care, or pharma). 3. Good knowledge of FDCA and other relevant cosmetic product regulations. 4. Strong communication, coordination, and documentation skills. 5. Detail-oriented with a proactive approach to compliance and deadlines.

We are seeking a highly skilled and driven International Business Development Manager to lead our pharmaceutical business expansion across Latin American (LATAM) markets. The candidate must possess a solid understanding of regulatory affairs, export documentation, and client account management within the pharmaceutical domain. Key Responsibilities: Drive business development in new territories across Latin America by identifying potential clients, partners, and distributors. Initiate and coordinate new product development based on client-specific and regional requirements. Manage and nurture long-term relationships with existing international clients and consistently seek opportunities to grow accounts. Liaise with cross-functional teams including Regulatory Affairs, Production, QA, SCM, and Finance to ensure smooth dossier compilation and timely submissions to Ministries of Health in respective LATAM countries. Oversee the entire regulatory process including dossier submission, follow-up with authorities, and product registration. Monitor production schedules and ensure timely execution of export orders in collaboration with logistics and manufacturing departments. Act as the central contact point for client communications related to product specifications, documentation, complaints, and technical clarifications. Plan and implement marketing and growth strategies tailored to specific country regulations and client needs. Coordinate plant audits requested by MOH authorities and work closely with the manufacturing units to ensure compliance. Work closely with marketing and product teams to resolve customer feedback and contribute to continuous product improvement. Preferred Candidate Profile: Minimum 5-10 years of relevant experience in international business development, regulatory affairs, or pharmaceutical exports. Background in Science/Pharma; an MBA will be an advantage. Ability to independently handle LATAM clients and manage end-to-end product registration cycles. Detail-oriented, self-driven, and adept at multi-department coordination. Perks: Health Insurance Shuttle facility, Fix office timing, Career growth training & development

Prepare and submit regulatory documentation for new and existing products. Monitor and interpret global regulatory requirements relevant to physiotherapy and medical equipment. Maintain regulatory compliance throughout the product lifecycle. Interface with regulatory agencies, notified bodies and external consultants. Ensure accurate and timely product registrations in target markets. Maintain up-to-date Device Master Files (DMF) and Technical Documentation. Support clinical evaluation and risk assessment documentation where required. Ensure products comply with applicable regulations, standards and guidelines Manage change notifications, renewals, amendments and post-market surveillance requirements. Support A for audits, CAPAs, internal documentation practices and inspections from regulatory bodies. Provide regulatory guidance to R&D, QA, Marketing during product development and changes. Review and approve labeling, packaging and promotional materials to ensure compliance. Collaborate with external consultants, legal teams or distributors for country-specific compliance. Monitor regulatory changes and industry updates across markets. Participate in external seminars, forums and internal training to build regulatory awareness. Supporting and enabling effective and efficient communication that results in operational excellence. Skills required: Degree in Biomedical Engineering, Pharmacy or related field. 36 years of regulatory experience in the medical device industry. Strong knowledge of regulatory frameworks (US FDA, EU MDR, CDSCO, ISO 13485). Experience with regulatory submissions and product registrations. Excellent technical data interpretation skills including problem solving Excellent oral and written communication skills with strong presentation skills Demonstrate subject matter and area expertise Excellent computer skills; Good knowledge of document management systems Excellent written and verbal communication skills Highly proficient with Microsoft Word, PowerPoint and Excel. Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines

Business: Piramal Pharma Solutions Department: CRA Travel: Moderate JOB OVERVIEW: Preparation of licenses application & filing them on governmental portals for approvals from Indian regulatory authorities required for manufacturing, marketing and export of products in domestic and overseas markets by PPL sites in India. KEY STAKEHOLDERS: INTERNAL: Manufacturing sites, R&D ,Program management, Supply Chain, Marketing, site regulatory KEY STAKEHOLDERS: EXTERNAL: Govt. authorities like State FDA, CDSCO, FSSAI, CBN, NCB, custom officials, Customers etc REPORTING STRUCTURE: (Reports To/ Direct Reports Y/N): Direct report to General Manager-RA ESSENTIAL QUALIFICATION: Graduate KEY ROLES/ RESPONSIBILITIES: KEY ROLES/RESPONSIBILITIES: Registration Application on various Government portals (CBN, Sugam, FSSAI & XLN India) for new user Ids creation. Follow up with State FDA Thane, CDSCO, FSSAI, NCB for grant of licenses Product Registration application in Form 41 on DCGI Sugam Portal. Written confirmation (WC) application on DCGI Sugam Portal for APIs. Preparation & Online Submission for Import License application in Form 10 Preparation & Online Submission for CBN permissions (Import Certificates & Quarterly return filling) Preparation & Online Submission of API, RLD Test License Applications (Form11 & Form CT 17). Preparation & Online Submission of CDSCO permission in Form CT-11, CT-14 & CT-15, Dual Use NOC & Export NOC Preparation & Online Submission of application on state FDA portals like Test Licenses (Form 29), wholesale license etc., Preparation & Online Submission of various CBN application (Import/ Export/Quota/Mfg. License). Quarterly return submission to CBN/NCB/State FDA Provide regulatory strategies and support all stakeholders w.r.t assessment of D&C Act Feedback on new guidance Review and assessment for selection of product for manufacturing at site as per the D&C act To create PR in SAP to process payment for various bills/Invoices received from consultants. KEY COMPETENCIES: written and spoken communications skills, cross functional collaboration, negotiation skills, meticulous planning and execution for timely receipt of approvals.

Roles and Responsibilities Manage regulatory affairs for domestic and international markets, ensuring compliance with FDA, ICH, EU regulations. Prepare dossiers for new product approvals, including artwork design and labeling requirements. Coordinate with cross-functional teams for formulation development, export documentation (DGFT), and licensing processes. Ensure legal metrology compliance by managing product registrations and maintaining accurate records. Provide guidance on regulatory matters to internal stakeholders and external partners. Handle regulatory documentation and submissions for Nutraceutical and Cosmetic products (domestic & export). Prepare dossiers, technical files, and product registrations as per domestic (FSSAI, CDSCO & Ect.) and international regulations. Ensure products comply with all legal and regulatory requirements of India and specific export markets. Regulatory handling and submission experience for Canada, USA, and European Union (EU) is mandatory. Review product labels, artworks, and marketing materials to ensure regulatory compliance. Liaison with internal departments (R&D, QC, QA, Marketing) for compiling regulatory documents. Maintain up-to-date knowledge of changing regulations in export markets. Desired Candidate Profile 2-10 years of experience in pharmaceutical industry with expertise in drug regulatory affairs. Bachelor's degree in Pharmacy (B.Pharma) or Master's degree (M.Pharma). Strong understanding of FSSAI guidelines and regulations governing food supplements/nutraceuticals.

• 4-7 years experiences for RA role in medical device and or pharmaceutical industry • Good understanding for regulations and policies issued by India, US FDA and EU, and ability to interpret international regulatory requirements.

Job Position: Cosmetics Regulatory Affairs Specialist Working Days: Monday to Friday Shift Time- 12 PM IST- 9 PM IST On-Site Role We are looking for a detail-oriented and knowledgeable Cosmetics Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong understanding of regulatory policies, documentation, and compliance requirements related to cosmetics. This role will be responsible for ensuring that all products meet local and international regulatory standards. Key Responsibilities: • Prepare and submit regulatory documentation for cosmetic product approvals and registrations. • Ensure compliance with all relevant regulations, guidelines, and standards related to cosmetics. • Maintain up-to-date knowledge of regulatory policies, rules, and procedures. • Liaise with regulatory agencies and authorities to facilitate product registrations and approvals. • Work closely with R&D, Quality, and Production teams to ensure regulatory compliance throughout the product lifecycle. • Review and approve product labeling, ingredient listings, and marketing materials for compliance. • Conduct regulatory risk assessments and provide guidance on compliance strategies. • Maintain regulatory databases and documentation for audits and inspections. • Stay updated on industry trends and regulatory changes that may impact the business. Qualifications & Requirements: • Bachelors degree in Pharmacy, Chemistry, Biology, or any related field. • At least 3 years experience in regulatory affairs within the cosmetics industry in Canada. • Strong knowledge of local and international cosmetic regulations and guidelines. • Experience in preparing and submitting regulatory applications and documentation. • Excellent attention to detail and organizational skills. • Strong communication and interpersonal skills. • Ability to work onsite and collaborate with cross-functional teams.

We are looking for a highly experienced and driven Senior Manager Business Development to lead and grow our pharmaceutical formulations business across Africa. The ideal candidate will possess a deep understanding of the African pharma market and a proven track record in driving sales and partnerships in the region.