regulatory affairs assistant

Allmed Solutions

<p>We are seeking a highly motivated and detail-oriented professional to join our Regulatory Affairs team. The Assistant Manager &ndash; Regulatory Affairs will play a key role in managing regulatory activities related to medical devices, ensuring full compliance with local and international regulatory standards.</p><p><b>Key Responsibilities:</b></p><ul><li>Develop and implement effective regulatory strategies to support product approvals.</li><li>Manage product registration processes and prepare regulatory documentation.</li><li>Ensure compliance with applicable regulatory requirements and standards.</li><li>Liaise with regulatory authorities for submissions, queries, and approvals.</li><li>Maintain regulatory compliance throughout the entire product lifecycle.</li><li>Provide regulatory guidance and updates to cross-functional teams.</li></ul><p><b>Requirements:</b></p><ul><li><b>Doctor of Pharmacy (Pharm-D)</b> degree.</li><li><b>1&ndash;3 years</b> of experience in Regulatory Affairs, preferably within the <b>medical devices industry</b>.</li><li>Strong communication, documentation, and analytical skills.</li><li>Ability to multitask, prioritize workloads, and meet tight deadlines in a fast-paced environment.</li></ul><p>Job Type: Full-time</p><p>Pay: Rs60,000.00 - Rs150,000.00 per month</p><p>Work Location: In person</p>

Assistant Manager – Regulatory Affairs

Ferring Pharmaceuticals, Inc.

<div><div>Job Description:</div><div>
Regulatory Affairs Associate</div><div></div><div>
At Ferring Pharmaceuticals, we help people around the world build families and live better lives. We are entrepreneurial and innovative, with a global team focused on scientific advances in the areas of reproductive and women&rsquo;s health, gastroenterology and urology. Ferring + You is all about working together and sharing ideas, so that we can bring science to life for patients around the world.</div><div>
Joining our Regulatory team, you will be part of an empowering and collaborative culture where your work plays a key role in ensuring patient safety, regulatory compliance and sustainable access to medicines. By working closely with cross-functional teams and external stakeholders, you will support regulatory excellence, life-cycle management and the consistent maintenance of our portfolio. Your contribution helps ensure that high-quality therapies remain available, compliant and trusted throughout their entire life cycle.</div><div></div><div>
Ferring+You</div><div></div><div>
We are looking for a Regulatory Affairs Associate to join our team and take a key role in regulatory compliance, quality assurance, document governance, and cross-functional business support in line with local regulations and global procedures, reporting directly to the Regulatory Affairs Manager.</div><div></div><div>
Your day at Ferring</div><ul><li><div>
Act as Document Accountable Person (DAP) and Document Controller (DC), ensuring document lifecycle management, consistency, and compliance</div></li><li><div>
Serve as the main local regulatory contact and manage regulatory compliance activities</div></li><li><div>
Coordinate new drug approvals, including dossier preparation, submissions, and follow-up with local Health Authorities</div></li><li><div>
Manage regulatory submissions, variations, renewals, and product lifecycle activities</div></li><li><div>
Support and coordinate regulatory inspections and maintain validity of licenses and certificates</div></li><li><div>
Monitor regulatory intelligence, assess impact, and proactively communicate regulatory changes</div></li><li><div>
Ensure timely and accurate updates in global and local regulatory systems (e-CTD, Veeva Vault, Track Wise, etc.)</div></li><li><div>
Prepare, review, and approve artworks and labeling to support submissions and product launches</div></li><li><div>
Review promotional and non-promotional materials in line with local regulations and global procedures</div></li><li><div>
Support Quality Management System (QMS) implementation and sustainability, including local market release</div></li><li><div>
Support regulatory and pricing applications, including document coordination and pricing data monitoring</div></li></ul><div></div><div>
Behind our collaboration&hellip;There&rsquo;s you</div><ul><li><div>
University degree in Pharmacy</div></li><li><div>
Min. 2-3 years of practical experience in regulatory and quality assurance</div></li><li><div>
Know-how of interactions with regulatory authorities</div></li><li><div>
Experience with e-CTD, Veeva Vault, Track Wise, and pricing is a plus</div></li><li><div>
Eager to learn personality, team player approach, attention to details</div></li><li><div>
Fluent in English language (written and verbal)</div></li></ul><div></div><div>
People come first at Ferring</div><div></div><ul><li><div>
Get inspired from our commitment to advocate for everyone&rsquo;s right to build a family, no matter who you are, where you live or who you love</div></li><li><div>
Our inclusive support package &ndash; &ldquo;Building Families at Ferring&rdquo; provides equal and accessible policies for all employees who wish to start their family journey, ensuring a global standard, irrespective of location and role</div></li><li><div>
Parental leave for both birthing and non-birthing parents</div></li><li><div>
Extended support on family building journey</div></li></ul><div></div><div>
Making a difference in the life of millions of people means we succeed by working together. Our diverse backgrounds, experiences, expertise, and perspectives enable us to find solutions to even the most challenging problems, and our success is tied to each team member&rsquo;s contributions. Imagine the power of your career when it&rsquo;s Ferring + You.</div><div></div><div>
Behind our purpose&hellip; There&rsquo;s you</div><div>
If our mission and your vision are aligned, please apply.</div><div>
We strive to build and maintain an inclusive and diverse workplace with equal opportunities and mutual respect for all employees regardless of their backgrounds and socioeconomic status.</div><div></div><div>
Location:</div>
Ferring Turkey</div>

Regulatory Affairs Associate

MBHHC

<ul><li>Bachelor&rsquo;s degree in <b>Pharmacy, Biotechnology, Chemistry, or a related field</b></li><li>Postgraduate qualification or certification in <b>Regulatory Affairs</b> (preferred)</li><li>Knowledge of <b>national and international regulatory guidelines</b> (e.g., drug, medical device, or cosmetic regulations)</li><li>Familiarity with <b>regulatory authorities</b> and submission processes</li><li>Training in <b>Good Regulatory Practices (GRP)</b>, <b>GMP</b>, or <b>GDP</b> is an advantage</li></ul><p>Technical &amp; Professional Skills</p><ul><li>Preparation, review, and submission of <b>regulatory dossiers</b></li><li>Experience with <b>product registration, renewal, and variations</b></li><li>Understanding of <b>labeling, artwork, and packaging compliance</b></li><li>Ability to interpret <b>regulatory laws, guidelines, and updates</b></li><li>Documentation management and <b>regulatory tracking systems</b></li><li>Coordination with internal departments and external authorities</li></ul><p>Job Type: Full-time</p><p>Pay: QAR6,000.00 - QAR10,000.00 per month</p><p>Education:</p><ul><li>Bachelor's (Preferred)</li></ul><p>Experience:</p><ul><li>Same role: 2 years (Preferred)</li></ul><p>License/Certification:</p><ul><li>QCHP (Preferred)</li></ul>

Registration and Regulatory Affairs Officer

Keeta

<p>1. Assist in preparing briefing documents, policy papers, and stakeholder engagement materials</p>
<p>2. Support the tracking of regulatory developments and government initiatives relevant to Keeta</p>
<p>3. Conduct background research on government entities (federal or non-federal) across United Arab Emirates</p>
<p>4. Maintain a database of stakeholders and key contacts across federal and local government entities</p>
<p>5. Help coordinate and attend meetings with internal and external stakeholders</p>
<p>6. Draft summaries, MOM, memos, and internal reports after meetings. Assisted in preparing stakeholder briefs and policy research for meetings with government entities.Supported drafting of presentations, reports, and MoUs for internal and external use.Conducted research on regulatory landscape and competitors to support advocacy strategies.Coordinated with cross-functional teams to prepare documents for key stakeholders</p>

Government Affairs

Mondelēz International

<p></p><div><div><p>Job Description</p><p></p><p><b>
Are You Ready to Make It Happen at Mondelēz International?</b></p><p></p><p><b>
Join our Mission to Lead the Future of Snacking. Make It With Pride.</b></p><p></p><p>
You execute the regulatory affairs strategy for your respective category or categories and geographical area using your technical and regulatory knowledge. You ensure our policies, regulatory programs and requirements of our portfolio carried out.</p><p></p><p><b>
How you will contribute</b></p><p></p><p>
You will deliver on the regulatory affairs strategy and compliance agenda and work with cross-functional stakeholders to assess regulatory business risks and opportunities. You will provide regulatory affairs expertise for technical regulatory developments and help in responses to challenges and crisis management. In this role, you will ensure that ingredients, product composition, claims and labelling compliance are within applicable regulations and company policies. In addition, you will provide guidance to stakeholders on developments in regulatory affairs, support regulatory impact assessments and change management, help develop regulatory affairs tools, and further develop your knowledge of regulatory, science and nutrition risks and opportunities in your market.</p><p></p><p><b>
What you will bring</b></p><p></p><p>
A desire to drive your future and purpose, accelerate your career and the following experience and knowledge:</p><ul><li>
Networking and communication skills</li><li>
Reliability and accuracy and an efficient work style</li><li>
Meeting deadlines</li><li>
Attending to detail</li><li>
Project management</li><li>
Regulatory affairs in an international and multi-functional environment</li></ul><p></p><p><b>
More about this role</b></p><p>
This position will be responsible for executing the regulatory affairs strategy for their respective categories and geographical area using their technical and regulatory knowledge ensuring compliance to our policies, regulatory programs and requirements of our portfolio.</p><p></p><p><b>
What you need to know about this position:</b></p><ul><li>
This position is a regional position that reports to the Regulatory Center and located at Thane, India. The candidate will be responsible for regulatory affairs for AMEA markets (within Regulatory Centre) and perform daily regulatory activities assigned to the internal hub. This position requires ensuring all projects and Regulatory activities assigned to the internal hub are delivered efficiently, in a timely manner, and are fully compliant with applicable regulations.</li><li>
Manage multiple regulatory project activities for the corresponding region and all categories where required</li><li>
Identifies and escalates risks and issues in regular governance meetings and drives resolution as needed</li><li>
Take personal responsibility for personal growth, driving team collaboration, and finding new, improved, and simpler ways to work.</li><li>
Collaborate and drive various processes and functions within RDQ to include Process/Product/Package Development, Research, Quality, Regulatory &amp; scientific affairs.</li></ul><p></p><p><b>
Education / Certifications:</b></p><p>
Bachelor&rsquo;s or equivalent in relevant field (Food Science or Nutrition preferred)</p><p></p><p><b>
Job specific requirements:</b></p><ul><li>
3- 5 years of experience in Regulatory or related field at a global food manufacturer.</li><li>
Strong attention to detail with a passion to advance regulatory compliance technical skills</li><li>
Basic to Intermediate knowledge in SAP-PLM especially in troubleshooting Issues.</li><li>
Basic knowledge to Digital Regulatory tools (Dragonfly Artwork Approval System, DECERNIS, etc.) including simple troubleshooting of system issues.</li><li>
Technology savvy and willing to work with new system testing and transferring knowledge and experience into SOPs, Job Aids and tool sheets.</li><li>
Basic knowledge of the national Food law regulations for countries of responsibility as well as International Standards (e.g. Codex, FSANZ, GCC) is preferred.</li><li>
Good knowledge of Mondelez business, i.e. market environment and Mondelez trade position as well as Mondelez manufacturing processes and portfolio.</li></ul><p></p><p><b>
Travel requirements:</b></p><p>
Very minimum (max once a year)</p><p></p><p><b>
Work schedule:</b></p><p>
Full-Time</p><p></p>
No Relocation support available<p></p><p>
Business Unit Summary</p><p></p><div>
Mondelēz International in the Middle East, North Africa and Pakistan serves the Middle East and Africa markets as well as Australia, New Zealand, the UK and Canada. Headquartered in Dubai, UAE, we have more than 2600 employees working across seven plants and six commercial offices; we make, bake, sell and deliver our products to customers. We are market leaders in key snacking categories with iconic global and local brands including Cadbury Dairy Milk chocolate, Milka, Oreo and belVita biscuits, Barni Cakes,Tang powdered beverage, Chiclets and Trident gum and Halls candy.</div><p></p><p>
Mondelēz International is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation or preference, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law.</p><p></p><p>
Job Type</p><p></p>
Regular<p></p>
Scientific Affairs &amp; Regulatory Affairs<p></p>
Product Quality, Safety and Compliance</div></div><p></p>

Regulatory Specialist, SARA

PROVEN

Overview <p>Job Title: Government Affairs Manager</p><p>Job Purpose: The Government Affairs Manager will be responsible for developing and maintaining strong relationships with government entities, regulatory bodies, and key stakeholders in Saudi Arabia. The role ensures compliance with local laws and regulations, supports the company's strategic objectives, and advocates for the company's interests in alignment with Saudi Vision 2030.</p> Key Responsibilities <ul><li>Act as the primary point of contact with all regulatory bodies in KSA and other relevant jurisdictions, ensuring timely, accurate, and legally sound responses to inquiries and requirements.</li><li>Oversee all licensing, permit issuance, renewals, and related government processes for the organization, ensuring compliance with applicable laws and regulations.</li><li>Monitor and interpret government policies, regulations, and emerging regulatory bodies; ensure their integration within the Legal function and company operations.</li><li>Develop and maintain the Regulatory Affairs Policy to reflect current legal obligations, compliance standards, and operational practices.</li><li>Collaborate with Corporate Planning, Legal, and other business units to support licensing, regulatory filings, and approvals for existing and new services.</li><li>Represent the company in government meetings, committees, and industry associations while building and maintaining strong networks with ministries, authorities, and key stakeholders.</li><li>Support management in resolving regulatory issues, preparing reports and policy briefs, and advising leadership on regulatory changes and emerging trends.</li><li>Drive engagement with CITC and other regulators, ensuring effective coordination across teams to align regulatory, legal, and operational objectives.</li><li>Ensure compliance with Saudi labor, commercial, and regulatory requirements while supporting Saudization and CSR initiatives in line with national goals.</li><li>Maintain strong working knowledge of all key Saudi government platforms (e.g., Qiwa, GOSI, Muqeem, Mudad, Balady, etc.) and ensure their effective use in company operations.</li></ul> Qualifications & Requirements <ul><li>Bachelor's degree in Public Administration, Political Science, Law, Business Administration, or a related field (Master's preferred).</li><li>Minimum of 7-10 years of experience in government relations, regulatory affairs, or public affairs, preferably in Saudi Arabia.</li><li>Strong understanding of Saudi government structure, regulations, and Vision 2030 initiatives.</li><li>Experience in regulatory filings, compliance processes, and government licensing.</li><li>Excellent networking, communication, and negotiation skills.</li><li>Proven track record of managing regulatory issues and government relations.</li><li>Fluency in Arabic and English (spoken and written).</li></ul> Seniority level <ul><li>Executive</li></ul> Employment type <ul><li>Full-time</li></ul> Job function <ul><li>Legal</li></ul> Industries <ul><li>Business Consulting and Services and Education</li></ul>

Government Affairs Manager (Education Industry)

India Health Link Pvt. Ltd.

<div><h3 class="jobSectionHeader"><b>Role Overview</b></h3><div>
India Health Link Private Limited is seeking a Regulatory Affairs &amp; Compliance Executive to support Indian and international regulatory activities for medical devices and healthcare products. The role will focus on CDSCO submissions, export regulatory coordination, early-stage US FDA strategy support, quality system documentation, and regulatory compliance across the product lifecycle.</div><div>
This position is ideal for a hands-on regulatory professional who is comfortable working across teams, managing documentation, and coordinating with external consultants and regulators.</div><div></div><h2 class="jobSectionHeader"><b><br>
Key Responsibilities</b></h2><h3 class="jobSectionHeader"><b>
Indian Regulatory Affairs (CDSCO)</b></h3><div>
Prepare, submit, and track CDSCO applications including Test Licenses, Manufacturing Licenses, and Free Sale Certificates (FSCs) through NSWS and SUGAM portals.</div><div>
Coordinate clinical study, testing, and evaluation requirements associated with regulatory submissions, working with clinical sites, CROs, manufacturing teams, and internal stakeholders.</div><div>
Track application status, respond to regulatory queries, and support timely approvals.</div><h3 class="jobSectionHeader"><b>
International Regulatory Affairs (Export Markets)</b></h3><div>
Support regulatory pathways for international/export markets in coordination with third-party regulatory agencies and consultants.</div><div>
Track country-specific regulatory dependencies, documentation requirements, and submission timelines.</div><div>
Maintain readiness and version control of documentation required for international regulatory submissions and renewals.</div><h3 class="jobSectionHeader"><b>
US FDA Regulatory Support</b></h3><div>
Support development and execution of a phased US FDA market-entry strategy, including identification of 510(k)-exempt product capabilities.</div><div>
Coordinate with CROs and regulatory consultants to assess FDA regulatory pathways, timelines, and scope of work.</div><div>
Assist in preparing for FDA Quality System and factory-readiness expectations as product scope and risk classification expand.</div><h3 class="jobSectionHeader"><b>
Quality System &amp; Compliance</b></h3><div>
Work closely with Quality Assurance teams to maintain ISO-compliant documentation, including Product Master Files (PMF), Quality Manual, regulatory SOPs, and technical documentation.</div><div>
Draft, review, and maintain regulatory reporting, vigilance, and post-market surveillance (PMS) documentation.</div><div>
Support internal and external audits related to regulatory, quality, and compliance requirements.</div><h3 class="jobSectionHeader"><b>
Data Privacy &amp; Other Regulatory Compliance</b></h3><div>
Coordinate implementation of data-privacy and data-compliance initiatives (including DPDPA requirements) in collaboration with internal teams and external vendors.</div><div>
Support compliance with applicable pricing, data protection, and regulatory frameworks (e.g., NPPA, DPDPA, where applicable).</div><h3 class="jobSectionHeader"><b>
Regulatory Strategy &amp; Documentation Management</b></h3><div>
Maintain device capability matrices, product classification mappings, and intended-use documentation across markets.</div><div>
Interpret regulatory requirements (CDSCO, US FDA, ISO, NPPA, DPDPA) and identify documentation gaps and mitigation actions.</div><div>
Act as a regulatory coordination point between manufacturing, QA, clinical partners, consultants, and management.</div><div></div><h2 class="jobSectionHeader"><b><br>
Qualifications &amp; Experience</b></h2><div>
Bachelor&rsquo;s degree in Life Sciences, Biomedical Engineering, Pharmacy, Regulatory Affairs, or a related discipline.</div><div>
2&ndash;5 years of experience in regulatory affairs, quality, or compliance within the medical device / healthcare / life sciences sector.</div><div>
Hands-on experience with CDSCO submissions and familiarity with NSWS/SUGAM portals.</div><div>
Working knowledge of ISO 13485, basic FDA regulatory concepts, and international regulatory frameworks.</div><div>
Strong documentation, coordination, and communication skills.</div></div><div></div>

Regulatory Affairs & Compliance Executive

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