regulatory affairs specialist

Parkville

<div>
 
 
 &ldquo;Parkville is committed to diversity, equity, and inclusion, and all employees are expected to support these values in all aspects of their work.&rdquo;
 
 
 
 
 
 
 
 
 Responsibilities:
 
 
 
 
 
 
 <ul>
 <li>
 Coordinate the preparation and submission of regulatory documents for Parkville&rsquo;s products, ensuring compliance with relevant standards.
 </li>
 <li>
 Stay updated on changes to economic, registration, and submission guidelines, maintaining regulatory documentation databases accordingly.
 </li>
 <li>
 Conduct weekly visits to the Ministry of Health to track pipeline status and address any required modifications during the registration and variation phases.
 </li>
 <li>
 Review product specifications, labeling, and batch records for compliance with applicable regulations and prepare necessary importation approvals for active pharmaceutical ingredients (APIs).
 </li>
 <li>
 Respond to governmental agencies' requests for product data and regulatory affairs statements, ensuring timely communication.
 </li>
 <li>
 Compile and organize re-registration files in accordance with ministerial decrees, ensuring all documentation is complete and accessible.
 </li>
 <li>
 Develop and review product leaflets (SPC &amp; PIL) and submit them to the appropriate regulatory authorities for approval.
 </li>
 <li>
 Prepare and maintain required stability files, bioequivalence files, and analytical dossiers for submission to regulatory bodies. of Health / CAPA.
 </li>
 </ul>
 
 
 
 
 
 
 Requirements:
 
 
 
 
 
 Education:
 
 
 
 Bachelor&rsquo;s degree from reputable university Degree in Pharmacy, Veterinary Medicine, Science is an advantage.
 
 
 
 
 
 
 Experience:
 
 
 
 Previous experience in pharmaceuticals industry from 3-4 years in the same position, responsibilities.
 
 
 
</div>

Regulatory Affairs Specialist

Jamjoom Pharma

<div>
 
 Role Overview
 
 
 
 We are seeking a detail-oriented and proactive
 
 Export Regulatory Affairs Specialist
 
 with mandatory fluency in French and English to support global regulatory compliance and international market access. This role is critical in managing export regulatory submissions, ensuring adherence to country-specific requirements, and coordinating cross-functionally to facilitate timely and compliant product exports.
 
 
 
 Key Responsibilities
 
 
 
 <ul>
 <li>
 Compile, format, and submit dossiers in CTD/eCTD format, ensuring accuracy, consistency, and compliance with international standards.
 </li>
 <li>
 Manage Certificates of Pharmaceutical Product (CPP) issuance and legalization processes.
 </li>
 <li>
 Ensure compliance with export regulations, customs requirements, and country-specific guidelines.
 </li>
 <li>
 Liaise with agents, distributors, and internal teams to resolve regulatory queries.
 </li>
 <li>
 Maintain up-to-date knowledge of global regulatory frameworks and changes impacting exports.
 </li>
 <li>
 Support audits, inspections from export countries.
 </li>
 <li>
 Develop and optimize workflows for regulatory submissions and export documentation.
 
 
 </li>
 </ul>
 
 Qualifications &amp; Requirements
 
 
 
 
 Education
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in pharmacy, Life Sciences, or a related field (mandatory).
 </li>
 <li>
 Additional training or certification in Regulatory Affairs is considered a plus.
 
 
 </li>
 </ul>
 
 Experience
 
 
 
 <ul>
 <li>
 3&ndash;5 years of hands-on experience in Regulatory Affairs within the pharmaceutical industry, with a strong focus on export submissions.
 </li>
 <li>
 Proven experience in CTD/eCTD dossier preparation, publishing, and submission for international markets.
 </li>
 <li>
 Solid knowledge of international regulatory requirements and export-related guidelines.
 </li>
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 Experience working with agents and distributors across multiple countries is an advantage.
 </li>
 <li>
 Fluency in French is a must (written and spoken).
 </li>
 <li>
 Fluency in English (written and spoken)
 
 
 </li>
 </ul>
 
 Skills &amp; Competencies
 
 
 
 <ul>
 <li>
 Regulatory Expertise: Strong understanding of global regulatory frameworks and export compliance requirements.
 </li>
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 Technical Writing: Excellent ability to prepare clear, accurate, and compliant regulatory documentation.
 </li>
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 Communication: Fluent in English (written and spoken); French language skills are required.
 </li>
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 Organization &amp; Attention to Detail: High level of accuracy in managing multiple dossiers and regulatory documents.
 </li>
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 Cross-functional Collaboration: Ability to work effectively with internal teams and external partners.
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 Systems &amp; Tools: Proficient in documentation management systems and MS Office applications.
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 Problem Solving: Proactive in identifying issues and driving timely regulatory solutions.
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 Integrity &amp; Compliance: Demonstrates strong ethical standards and commitment to regulatory compliance.
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 </ul>
</div>

Export Regulatory Affairs specialist (French)

PepsiCo

<div>Overview:

The role will ensure to support regulatory compliance work programs including artworks and product related communication, ingredients and formulae compliance, packaging compliance, factory licensing, label approvals from respective provincial food authorities, product registration and other related activities to ensure that they comply
with the standards and requirements from regulatory standpoint. 
The role is also key for maintaining and working with the global team on the Beverage development platform Product Vision (FSS). The person will also be responsible for global digitization agenda including CAST, PLM, QB, PRCS etc. 
Additionally, the role will conduct gap analysis on new regulations/directions issued by competent authorities; Support execution work to plug identified gap by working with cross-functional teams and will support capability building of business stakeholders/franchisee/bottlers teams on newer regulatory developments 
The role will also support advocacy (external affairs) work and proactive engagement with all the authorities and key stakeholders for ease of doing business.
Responsibilities:
<div>
Regulatory Affairs Capability</div><ul><li>
Expert resources for the business on Food and Beverage regulations and their application for all PepsiCo products manufactured or sold in Pak MU
</li><li>Provide guidance and training to key stakeholders relating to regulatory requirements</li></ul><div>
Compliance</div><ul><li>
Ensure compliance with all aspects of food and beverage legislation including those in relation to ingredients, packaging, manufacture, composition, labelling and advertising. Accountabilities include:<ul><li>
Work with R&amp;D, marketing and Supply Chain to ensure ongoing compliance with food and beverage regulations</li><li>
Responsible for implementing new food regulations</li><li>
Key partner in import and export initiatives</li><li>
Support for factory licensing, label approval, registration of products and Halal assurance</li><li>
Coordinate with Supply chain and sales team for annual product sampling and analysis by the authorities</li><li>
Accountable for digitization agenda including CAST, PLM, PRCS, QB, FSS etc.</li></ul></li></ul><div>
Innovation, Productivity and Commercial projects</div><ul><li>
Provide comprehensive partnership/support to projects from concept to shelf, incl.:<ul><li>
Provide Regulatory input to TSG/SG as required</li><li>
Product design, composition, packaging and labelling requirements</li><li>
Interpretational guidance on claims and positioning</li><li>
Aspects of advertising and promotion governed by food legislation</li></ul></li></ul><div>
External Affairs</div><ul><li>
Monitor regulatory changes and ensure R&amp;D and business colleagues are aware.</li><li>
Represent PepsiCo in relevant trade associations and with regulators</li><li>
Work with sector/global Regulatory and PPGA teams to develop positions and respond to regulatory developments.</li><li>
Build and maintain a network of contacts in the food industry, trade associations and regulatory authorities.
</li></ul>Qualifications:
<ul><li>Science Degree. Food Science or related discipline will be an advantage</li><li>
Language: Excellent command of English
</li><li>Detailed knowledge of Pakistan + CODEX food and beverage regulations, particularly areas relating to ingredients, final product, contaminants, packaging/food contact materials, labelling and manufacture. Knowledge of other regulatory regime including EU, FDA will be an advantage.</li><li>
Required experience: 4-6 years:<ul><li>
A track record in interpreting and applying regulatory requirements in a commercial setting.</li><li>
Experience of implementing new regulations in a business.</li><li>
Experience in monitoring regulatory developments.</li><li>
Experience in agreeing on interpretations with regulatory authorities.</li></ul></li><li>
Strong executional capability and project management skills.</li><li>
Attention to detail and forethought of impact.</li><li>
Results-oriented, proactive self-starter, able to work on own initiative and as a team player.</li><li>
Ability to integrate into and communicate with different levels and functions of the organization.</li></ul></div>

R&D Regulatory Affairs Analyst (PO1)

PRANIC DRUG STORE LLC

Job Description: We are seeking a Regulatory Affairs Pharmacist to handle product registration and regulatory activities in the Sultanate of Oman. The ideal candidate will liaise with the Ministry of Health (MOH) and other relevant authorities to ensure our products meet all local regulatory requirements. This is an excellent opportunity for a motivated pharmacist to grow in regulatory affairs and make a meaningful impact in the pharmaceutical industry.Key Responsibilities:<ul><li>Prepare, compile, and submit product registration dossiers to the Omani Ministry of Health.</li><li>Ensure all product documentation, labeling, and packaging comply with local regulations.</li><li>Follow up with MOH on product registration approvals.</li><li>Maintain accurate regulatory records and track progress of submissions.</li><li>Provide guidance on regulatory compliance for internal teams.</li><li>Assist with any audits or inspections as required.</li></ul>Requirements:<ul><li>Bachelor&rsquo;s degree in Pharmacy (BPharm / PharmD).</li><li>0&ndash;5 years of experience in the pharmaceutical industry.</li><li>Valid Sultanate of Oman Pharmacist License is mandatory.</li><li>Knowledge of MOH regulations and product registration processes is a plus.</li><li>Strong organizational and communication skills.</li><li>Ability to work independently and manage multiple tasks.</li></ul>Why Join Us:<ul><li>Opportunity to grow and gain experience in regulatory affairs.</li><li>Work in a dynamic team environment.</li><li>Contribute to bringing quality healthcare products to Oman.</li></ul>How to Apply: Interested candidates should submit their CV and a copy of their valid Sultanate of Oman pharmacist license to pranicdrugstorellc@gmail.com or apply directly via Indeed.Job Type: Full-time

Regulatory Affairs Pharmacist – Oman Experience Mandatory

Sanofi

<div>EM&amp;S Turkey Regulatory Affairs Officer<ul><li>
Location: Istanbul</li></ul>
About the job
Reporting to the EM&amp;S Middle East Quality Manager, the Regulatory Affairs Officer supports regulatory compliance and lifecycle activities related to External Manufacturing &amp; Supply operations. The role ensures alignment between regulatory dossiers and industrial practices at CMO, in compliance with local regulations and Sanofi standards, and acts as a key interface between Affiliate Regulatory Affairs and CMO.
This position contributes to the implementation of Sanofi&rsquo;s Quality and Regulatory policies within External Manufacturing &amp; Supply activities, ensuring regulatory compliance of manufactured products, supporting product lifecycle management, and enabling timely execution of regulatory-impacting changes and transfers.
Main responsibilities:<ul><li>
Regulatory Compliance &amp; Lifecycle Management<ul><li>
Ensure regulatory compliance between CMC dossiers / Marketing Authorizations and manufacturing practices at CMOs</li><li>
Coordinate the regulatory compliance exercise with the assigned Hub</li><li>
Maintain regulatory compliance of manufactured products throughout their lifecycle (variations, renewals, annual updates)</li><li>
Support the preparation, maintenance, and update of CMC dossiers for assigned products</li><li>
Assess the regulatory impact of proposed changes (change controls) originating from CMO or internal sites</li><li>
Support Product Registration Renewals and periodic regulatory submissions (Annual Reports, PQRs&hellip;)</li><li>
Contribute to the implementation of Sanofi Quality policy across External Manufacturing activities</li></ul></li><li>
Regulatory Interface &amp; Submissions Support<ul><li>
Act as the regulatory interface between Affiliate Regulatory Affairs, site Regulatory teams, CMOs, and the Hub</li><li>
Consolidate industrial and technical data required for local and regional registrations and variations</li><li>
Support responses to Health Authority requests (RFI, deficiency letters)</li><li>
Monitor submission and approval status and ensure appropriate communication of regulatory approvals and implementation timelines</li><li>
Perform regulatory review and approve documentation provided by the Hub prior to submission while ensuring documentation management within Sanofi systems (Veeva Vault)</li><li>
Manage regulatory activities in Veeva Vault (Regulatory Objective, SCP&hellip;)</li><li>
Participate in Quality System activities, including Change Control, CAPA, PQR, training, and documentation management</li><li>
Support regulatory aspects of technology transfers, product transfers, and site projects in collaboration with Quality, Supply Chain, and Project teams</li><li>
Prepare the Variation Record Card (VRC) for product divestments</li></ul></li><li>
Site Compliance &amp; Regulatory Maintenance<ul><li>
Compile and maintain product specification files and support updates of the Site Master File (SMF)</li><li>
Support the maintenance of manufacturing licenses, GMP certificates, site registrations, and renewals</li><li>
Participate in internal audits, external audits, and regulatory inspections, supporting preparation and follow-up activities</li><li>
Contribute to continuous improvement initiatives related to Regulatory Affairs processes and procedures</li></ul></li><li>
HSE &amp; Compliance Awareness<ul><li>
Ensure compliance with applicable HSE rules and procedures</li><li>
Report accidents and incidents occurring in the workplace in line with internal requirements</li><li>
Support site and Quality initiatives promoting compliance and quality culture (Quality Day)</li></ul></li><li>
Compliance &amp; Ethics<ul><li>
Comply with the Company's Code of Ethics, upholding high professional standards of conduct</li><li>
Demonstrate a commitment to protecting and enhancing the Company's reputation</li><li>
Maintain comprehensive knowledge of regulatory guidance, technical developments, ethics, and governance requirements relevant to the role</li><li>
Apply ethical principles and governance standards to all work activities</li></ul></li></ul>
About you
<ul><li>Education: Bachelor&rsquo;s degree or higher in Pharmacy, Chemistry, Microbiology, Quality, or a related scientific field</li><li>
Experience: At least 5 years&rsquo; experience in the pharmaceutical industry, preferably with 2 years+ in a similar role, working in a regulatory team.<ul><li>
Proven ability to manage multiple priorities effectively</li><li>
Experience in management of change control with regulatory impact</li></ul></li><li>
Skills:
<ul><li>Good knowledge of pharmaceutical regulatory requirements (EU and local regulations)</li><li>
Understanding of CMC dossiers, variations, and product lifecycle management</li><li>
Familiarity with External Manufacturing / CMO environments is a plus</li><li>
Working knowledge of Quality Systems (Change Control, CAPA)</li><li>
Ability to compile, review, and manage technical and regulatory documentation</li><li>
Comfortable using digital tools (Excel, PowerPoint, and regulatory document management systems)</li></ul></li><li>
Languages: Fluency in English is required, knowledge of other languages is an asset</li></ul>
Why choose us?<ul><li>
Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.</li><li>
Be part of an organization that invests in people, technology, and sustainability, leading the industry in low-carbon manufacturing and digital transformation.</li></ul>
#LI-EUR
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EM&S Turkey Regulatory Affairs Officer

Grifols Egypt for Plasma Derivatives (GEPD)

<div>
 
 Job Objective:
 
 
 
 Regulatory Affairs Senior Manager is the responsible for any communication and coordination with EDA , European Medicines Agency (EMA) and/or other International Health Authorities (as required).
 
 
 Liaison and support between regulatory bodies and operating divisions of the company. Responsible for reviewing and managing the regulatory function by ensuring compliance with (EDA), European Medicines Agency (EMA) and other International Health Authorities (as required), regulations and guidelines to obtain and maintain the corresponding approvals for any GMP area, including Plasma Supply Chain, Manufacturing facility, Exportation / Importation for plasma and/or Final Product in Egyptian Market or others (as required).
 
 
 
 Key responsibility:
 
 
 
 <ul>
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 Communication with local and international Health Authorities. Support, communication and coordination (as necessary) with local Health Authorities for Plasma Supply chain and Manufacturing facilities for the process of licensing, certification, exportation, importation, and finished product release.
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 Ensure that applicable Health Authorities guidelines, rules and regulations are applied up to date, covering plasma or finished products or GMP sites and regulatory processes.
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 Review and manage the licensing and GMP certification regulatory process for Plasma supply chain and manufacturing. Ensure any submissions related to local and international Health Authority are performed on time for initial licensing and renewal (if applicable) to maintain valid license and/ or certification is maintained in all facilities per existing regulations.
 </li>
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 Review all the documentations prepared to be submitted to EDA , International Health Authorities and any Certification entities.
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 Change notification to Local and International Health Authorities.
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 Change notification and customers related to Change Control implementation.
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 To assist Direct Manager in any assigned duties.
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 Manage Regulatory Affairs Area to ensure compliance with the above-mentioned points.
 
 
 
 </li>
 </ul>
 
 Academic &amp; Professional Experience Required
 
 
 
 <ul>
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 Bachelor s Degree in Health-related Sciences, preferably pharmaceutical area.
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 Post-Graduate Certification in Quality Management.
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 Knowledge of cGMP requirements preferred.
 </li>
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 Minimum of 4 years of Management or technical leadership experience is required.
 </li>
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 Minimum of 8 years of related experience in Regulatory Affairs field, including Pharma
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 Manufacturing background, and Final Product importation and exportation experience.
 </li>
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 Preferably with experience on EMA Regulatory requirements and submissions.
 
 </li>
 </ul>
</div>

Regulatory Affairs Sr. Manager

Element Solutions Inc

<div>
 Business Unit: ESI HQ &amp; Other
 
 
 Division: Legal - Business
 
 
 
 Challenge Yourself and Impact the Future!
 
 
 
 Element Solutions Inc (NYSE:ESI) is a leading specialty chemicals company whose operating businesses formulate a broad range of solutions that enhance the performance of products people use every day. Developed in multi-step technological processes, our innovative solutions enable our customer manufacturing processes in several key segments, including electronic circuitry, communication infrastructure, automotive systems, industrial surface finishing, and offshore energy.
 
 
 Customers of our businesses use our innovation as a competitive advantage, relying on us to help them navigate in fast-paced, high-growth markets. For example, in-care technology, from infotainment to driver assistance, is accelerating the paste of new product development and automotive markets, and with a deep market expertise in electronics, we sit at the intersection of the fast-growing market, changing the competitive playing field for automotive manufacturers, with a long-standing presence.
 
 
 We strive to embody the five 'Elements of our Culture'- our '5C's'; Challenge, Commit, Collaborate, Choose, and Care. These core values are the foundation of our organization which our employees embrace in their interactions with customers, colleagues and other stakeholders, to drive financial performance and create a rewarding work environment.
 
 
 
 Who are we looking for?
 
 
 
 We are looking for a meticulous and knowledgeable
 
 Regulatory Specialist
 
 to join our global regulatory affairs team. As part of the EU Regulatory Affairs team, the Regulatory Affairs Specialist supports compliance of chemical products placed on the European market. The role works closely with internal teams and external partners to ensure product safety, regulatory compliance, and customer support across the EMEA region, with a strong focus on EU chemical legislation.
 
 
 This position plays a key role in maintaining the company&rsquo;s license to operate by translating regulatory requirements into practical actions that support business continuity and customer trust.
 
 
 
 What will you be doing?
 
 
 
 As a Regulatory Specialist, you will be responsible for the following activities:
 
 
 
 <ul>
 <li>
 Prepare, review, and maintain Safety Data Sheets (SDS) in line with EU and local regulations
 </li>
 <li>
 Ensure correct classification, labelling, and packaging of chemical mixtures (CLP/GHS)
 </li>
 <li>
 Maintain transport classifications (ADR, IMDG, IATA)
 </li>
 <li>
 Review regulatory requirements related to product manufacture, import, and use in EMEA
 </li>
 <li>
 Monitor regulatory changes and highlight potential business impacts
 </li>
 <li>
 Support regulatory submissions and notifications, including PCN, C&amp;L Inventory, and REACH obligations
 </li>
 <li>
 Ensure product registrations and declarations are submitted on time
 </li>
 <li>
 Coordinate data collection from suppliers, partners, and consultants when needed
 </li>
 <li>
 Act as a regulatory contact for internal teams (R&amp;D, Manufacturing, Supply Chain, Product Management)
 </li>
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 Support customer and internal regulatory requests
 </li>
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 Contribute to raw material compliance activities (e.g. SVHC, restricted substances)
 </li>
 <li>
 Support system updates, testing, and process improvements
 </li>
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 Participate in European regulatory projects and data-quality initiatives
 
 
 
 </li>
 </ul>
 
 Who are You?
 
 
 
 The ideal candidate needs to have
 
 
 
 <ul>
 <li>
 Degree in Chemistry, Chemical Engineering, Environmental Science, or similar
 </li>
 <li>
 2&ndash;4 years of experience in regulatory affairs, product safety, or SDS authoring
 </li>
 <li>
 Good knowledge of EU chemical legislation (REACH, CLP/GHS, ADR/IMDG/IATA)
 </li>
 <li>
 Experience with SDS authoring tools (e.g. ChemGes, Chemmate, SAP or similar)
 </li>
 <li>
 Ability to interpret regulatory requirements and apply them to products
 </li>
 <li>
 Very good knowledge of written and spoken English
 </li>
 <li>
 Comfortable working with data and standard office tools
 
 
 
 </li>
 </ul>
 We understand that not all candidates may meet the requirements listed above. If you believe you have the knowledge and experience necessary to excel in this role, we encourage you to apply.
 
 
 
 What competencies will you need?
 
 
 
 To be successful in this role, you will need to
 
 
 
 <ul>
 <li>
 Have Strong attention to detail and accuracy
 </li>
 <li>
 Good analytical and problem-solving skills
 </li>
 <li>
 Ability to manage multiple tasks and deadlines
 </li>
 <li>
 Be a Clear communicator, able to explain regulatory topics to non-experts
 </li>
 <li>
 Team-oriented and comfortable working in an international environment
 </li>
 <li>
 Proactive, well-organized, and motivated to grow regulatory expertise
 
 
 
 </li>
 </ul>
 
 We are Offering...
 
 
 
 As a member of our highly experienced EMEA regulatory team within a global company, you will have the possibility to
 
 
 <li>
 Exposure to a diverse international product portfolio
 </li>
 <li>
 Ongoing training and development in chemical regulations and compliance
 </li>
 <li>
 Hybrid working model with international and cross-functional collaboration
 </li>
 Expected travel (likely minimal:
 
 
 You will be receiving a competitive base salary, participating in a generous performance-related bonus scheme. In addition, you will also receive an outstanding cafeteria. We offer accident, life, and health insurance, and travel allowance for those who commute to our site in Dunaharaszti.
 
 
 At ESI, we are committed to solving the complex and evolving needs of our customers through innovation and high-quality standards. We are focused on bringing cutting-edge and environmentally sustainable solutions to the market. Our people are the critical resource required to make that happen. We support your success by creating a strong, inclusive culture, competitive total rewards, and an appropriate work-life balance. #ALLMAINCOUNTRIES
 
 
 
 Equal Opportunity Employer
 
 
 
 All qualified applications will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected category applicable under federal, state and local laws.
 
 
</div>

Regulatory Specialist

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