regulatory affairs manager

Duke Energy

<div><div>Important Application Submission Information</div>
In order to ensure your application is successfully received before the job posting expires, please submit your application by 11:59 PM on Thursday, November 13, 2025<div></div><div>
More than a career - a chance to make a difference in people's lives.</div><div></div><div>
Build an exciting, rewarding career with us &ndash; help us make a difference for millions of people every day. Consider joining the Duke Energy team, where you'll find a friendly work environment, opportunities for growth and development, recognition for your work, and competitive pay and benefits.</div><div></div><div>
Job Description</div><div><i>
The preferred location for this position is in Raleigh, North Carolina; however, the hiring manager will consider Charlotte, NC if needed. The exact location will be determined at the time of offer based on business needs.</i></div><div></div><div>
Job Summary</div><div>
This position serves as the primary subject matter expert and point of contact for customer-related issues in North Carolina that have been, or may prospectively be, escalated to regulatory authorities. It serves as a liaison between Duke Energy and key external stakeholders including the North Carolina Utilities Commission (NCUC) Staff, NC Public Staff, and intervenors in state regulatory proceedings. Additional responsibilities include analysis of emerging regulatory and legislative issues, and the development of recommended and alternative responses to these issues. This role manages regulatory applications for transmission and generation approvals, attends NCUC meetings as needed, represents Duke Energy in formal complaints, and reports on grid conditions and storm events to the NCUC and Public Staff.</div><div></div><div>
This position works closely with the following departments: State Regulatory-Legal, Carolinas Rates Department, Grid Operations (ECC), System Optimization, Carolinas Consumer Affairs, Carolinas Customer Service Center, and Carolinas Customer Delivery (including Carolina&rsquo;s transmission, distribution, and vegetation management). There is frequent interaction with regulatory agencies, primarily the NC Public Staff and NCUC Staff</div><div></div><div>
The ideal background for this person would be engineering experience in the distribution or transmission space.</div><div></div><div>
Responsibilities</div><ul><li><div>
Lead the resolution of escalated customer issues. Investigate complaints and recommend response based upon compliance with governing rules and statutes and sound business judgment. Communicate with customers, internal stakeholders, Carolinas Consumer Affairs, and regulatory authorities as appropriate. Negotiate settled resolution or lead Duke Energy's formal response.</div></li><li><div>
Assist regulatory attorneys and business units to ensure that Duke Energy service regulations and line extension plans are followed consistently in accordance Commission rules and N.C. general statutes. Lead or support regulatory filings such as general rate cases, certificates of public convenience and necessity, special tariff requests, routine regulatory reports, and discovery responses. Provide expertise to internal stakeholders and regulatory authorities concerning the proper interpretation and resolution of tariff or other Commission-related questions and issues such as credit and collection policies, line extension plans, and economic development riders.</div></li><li><div>
Maintain positive working relationships with NC Public Staff and NCUC Staff. Facilitate effective communication to regulators concerning matters of interest including storms, grid conditions, system outages &amp; restoration efforts, generation &amp; transmission outages, emerging industry matters, and rulemakings. Serve as an effective intermediary between regulators and internal business units.</div></li><li><div>
Identify, research, and analyze emerging regulatory and legislative issues. Develop alternatives and make recommendations concerning Duke Energy responses. Coordinate with key internal and external stakeholders to promote resolutions that reasonably balance shareholder and intervenor perspectives.</div></li></ul><div></div><div>
Basic/Required Qualifications</div><ul><li><div>
Bachelor&rsquo;s degree</div></li><li><div>
In addition to bachelor's degree, five (5) years minimum of related work experience.</div></li><li><div>
In lieu of bachelor's degree AND five (5) years minimum of related work experience listed above, high school diploma/GED AND ten (10) years minimum of related work experience</div></li></ul><div></div><div><br>
Desired Qualifications</div><ul><li><div>
Bachelor&rsquo;s degree in engineering</div></li><li><div>
Generation, Transmission or Distribution operations experience.</div></li><li><div>
Strong grasp and fundamental understanding of energy delivery overall, including, but not limited to, Duke Energy's generation assets, both distributed and centralized, as well as the Carolinas transmission and distribution systems, and an ability to articulate the nuances both internally and externally.</div></li><li><div>
Excellent listening and communication skills and the ability to interact with external customers, regulators, and staffers in a professional, courteous, and empathetic manner at all times.</div></li><li><div>
Experience or working knowledge of DEC and DEP NC state regulatory obligations to provide electric service.</div></li><li><div>
Strong understanding of regulatory obligations and electric reliability.</div></li><li><div>
Familiarity with and understanding of Duke Energy rates, service regulations, line extension plans, and solar &amp; net metering tariffs.</div></li><li><div>
Working knowledge of emerging regulatory and legislative issues.</div></li><li><div>
Ability to coordinate with key internal and external stakeholders to promote resolutions involving regulatory attorneys, customer service, rates, and energy delivery is beneficial.</div></li><li><div>
Detailed knowledge of commission rules, governing statutes, Duke Energy tariffs, and relevant regulatory rulings of precedent.</div></li><li><div>
Demonstrated analytical and critical thinking skills.</div></li><li><div>
Ability to work effectively with a wide range of professional adversaries in regulatory proceedings.</div></li><li><div>
Ability to multi-task and navigate between multiple issues at one time.</div></li><li><div>
Ability to thrive when working with complex and challenging issues.</div></li><li><div>
Experience communicating with and resolving issues for large customers.</div></li><li><div>
Prior work experience directly involving regulatory attorneys, customer service, rates, and customer delivery is beneficial.</div></li><li><div>
Excellent verbal and written skills are required.</div></li><li><div>
Effective negotiation skills with excellent people skills.</div></li><li><div>
Experience managing external stakeholder expectations.</div></li></ul><div></div><div>
Working Conditions</div><ul><li><div>
Ability to work outside of normal business hours when needed.</div></li><li><div>
Hybrid mobility classification - work will be performed from both remote and onsite locations after the onboarding period. However, hybrid employees should live within a reasonable commute to a Duke Energy facility.</div></li></ul><div></div><div>
#LI-VF1</div><div>
#LI-Hybrid</div><div></div><div>
Travel Requirements</div>
5-15%<div></div><div>
Relocation Assistance Provided (as applicable)</div>
No<div></div><div>
Represented/Union Position</div>
No<div></div><div>
Visa Sponsored Position</div>
No<div>
Please note that in order to be considered for this position, you must possess all of the basic/required qualifications.</div><div><div>
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Do Not Sell My Personal Information (CA)</div></div><div><div>
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NC Regulatory Affairs Manager

Rawaj - Human Capital Management

<div><p>Leverage your abilities and join a leading medical device manufacturer driving compliance and innovation across Saudi Arabia.</p><p>
The Regulatory Affairs Manager ensures all medical devices comply with SFDA and international standards by managing product registrations, renewals, and documentation.</p><h3 class="jobSectionHeader"><b>
Key Accountabilities</b></h3><ul><li><p>
Prepare, review, and submit regulatory files, technical documentation, and ESTD to SFDA.</p></li><li><p>
Manage communication with SFDA authorities for product approvals and renewals.</p></li><li><p>
Track and interpret new regulations impacting medical device compliance.</p></li><li><p>
Maintain product registration database and ensure documentation accuracy.</p></li><li><p>
Collaborate with QA, R&amp;D, and Production to ensure regulatory alignment.</p></li></ul><h3 class="jobSectionHeader"><b>
Knowledge, Skills, and Experience</b></h3><ul><li><p>
Bachelor&rsquo;s degree in Pharmacy, Biomedical Engineering, or Science.</p></li><li><p>
8+ years of experience in Regulatory Affairs for medical devices.</p></li><li><p>
Solid knowledge of SFDA requirements, ISO 13485, and MDSAP.</p></li><li><p>
Strong documentation and submission management skills.</p></li><li><p>
Excellent English communication.</p></li></ul></div>

Regulatory Affairs Manager| Officer – Medical Devices | Saudi Arabia

Human Capital HR Solutions

<p>The <b>Assistant Manager &ndash; Regulatory &amp; Corporate Affairs</b> will ensure full compliance with all statutory and regulatory requirements while supporting the company&rsquo;s legal, licensing, and corporate governance activities. The role requires close coordination with internal departments, legal counsel, and government authorities to maintain a compliant and well-governed business environment.</p><p><b>Key Responsibilities:</b></p><ul><li>Ensure compliance with <b>local laws, regulatory bodies, and industry standards.</b></li><li>Manage <b>regulatory filings, licenses, renewals, and statutory documentation.</b></li><li>Liaise with <b>government departments, legal advisors, and industry associations.</b></li><li>Support <b>corporate documentation</b>, board meetings, and policy development.</li><li>Prepare and review <b>contracts, agreements, and legal correspondences.</b></li><li>Facilitate <b>internal and external audits</b> conducted by regulatory authorities.</li><li>Monitor and report on <b>new or updated regulations</b> affecting company operations.</li></ul><p>Job Type: Full-time</p><p>Pay: Rs120,000.00 - Rs170,000.00 per month</p><p>Work Location: In person</p>

Assistant Manager – Regulatory & Corporate Affairs

Amgen

<p></p><div><p><b>HOW MIGHT YOU DEFY IMAGINATION?</b></p><p>
You&rsquo;ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission&mdash;to serve patients&mdash;drives all that we do. It is key to our becoming one of the world&rsquo;s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.</p><p></p><p><b>
CW Associate Regulatory Affairs - based in Dubai</b></p><p></p><p><b>
Live</b></p><p><b>
What you will do</b></p><p>
Let&rsquo;s do this. Let&rsquo;s change the world. In this vital role, you will manage country-specific regulatory affairs for Amgen's molecules, coordinate and implement regulatory submissions, ensure compliance with corporate and local requirements and lead documentation for local submissions under Senior Manager's guidance :</p><ul><li><p>
Ensures regulatory submissions are made on time and meet Amgen&rsquo;s corporate and local regulatory requirements</p></li><li><p>
Reviews promotional and non-promotional materials.</p></li><li><p>
Exchanges regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner.</p></li><li><p>
Partners with International Regulatory Leads (IRLs) and Global Regulatory Leads (GRLs) to support the regulatory development, registration, and lifecycle management of all Amgen molecules.</p></li><li><p>
Partners with peers to ensure consistency on procedures.</p></li></ul><p></p><p><b>
Win</b></p><p><b>
What we expect of you</b></p><p>
We are all different, yet we all use our unique contributions to serve patients. The Regulatory Affairs professional we seek is a teammate with these qualifications.</p><p></p><p><b>
Basic Qualifications:</b></p><ul><li><p>
Bachelor`s degree in Pharmaceutical Science</p></li><li><p>
Working with policies, procedures and SOP&rsquo;s.</p></li><li><p>
Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.</p></li><li><p>
Knowledge of the Gulf legislation and regulations</p></li><li><p>
Understanding of regulatory activities and how they impact other projects and/or processes</p></li><li><p>
Understanding of drug development</p></li><li><p>
Demonstrate ability to work in teams</p></li><li><p>
Ability to understand and communicate scientific/clinical information</p></li></ul><p></p><p><b>
Preferred Qualifications:</b></p><ul><li><p>
Regulatory experience of the Gulf Markets</p></li><li><p>
Knowledge of regional countries legislation and regulations relating to medicinal products in the Gulf Markets.</p></li><li><p>
Experience interacting with regulatory agency in the Gulf markets</p></li></ul><p></p><p><b>
Thrive</b></p><p><b>
What you can expect of us</b></p><p>
As we work to develop treatments that take care of others, we also work to care for our teammates&rsquo; professional and personal growth and well-being.</p><p>
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.</p><p></p><p><b>
Apply now</b></p><p><b>
for a career that defies imagination</b></p><p>
Objects in your future are closer than they appear. Join us.</p><p><b>
careers.amgen.com</b></p><p></p><p>
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.</p><p>
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.</p></div><p></p>

Associate Regulatory Affairs - based in Dubai

Veterans United Home Loans

<div><div>As an External Affairs Manager, you will be responsible for state and federal regulatory affairs and public policy initiatives, as well as internal communications with company employees regarding regulatory, executive, and legislative issues. You will be responsible for identifying and tracking legislative and regulatory proposals that could impact the company and working with the external affairs team to develop strategies to impact these proposals. You will also work with other stakeholders, including various industry associations. This includes advocating the interests of the company, its customers, and its stakeholders before various levels of government, trade organizations, and other groups. Significant travel is required.</div><div></div><div>
Job duties will vary upon assignment but may include:</div><ul><li><div>
Manage and execute external affairs strategy by working closely with company business units on federal, state, and local issues of interest to the company. Work alongside state and federal government relations consultants, monitor proposed state and federal legislation and regulation for proposals relevant to the interest of the company.</div></li><li><div>
Develop and maintain relationships with state and federal government personnel. Develop and maintain relationships with key business partners, trade associations, and other organizations as directed.</div></li><li><div>
Remain knowledgeable on company and industry guidelines and processes. Keep up to date and ensure compliance on all corporate policies, rules, regulations, and laws affecting the company and managing advocacy related thereto as directed.</div></li><li><div>
Advocate the interests of the company, its customers, and its stakeholders before regulatory, legislative, and executive bodies and other groups as directed.</div></li><li><div>
Actively contribute to making the team and culture stronger by assisting with other duties as needed, excluding licensed activity.</div></li><li><div>
Required to travel up to 20% of the time.</div></li><li><div>
Required experience in government affairs, state or federal agencies, and/or congressional or state legislator staff.</div></li></ul><div></div><div>
We&rsquo;re looking for someone who can be passionate about their job and have fun doing it, who will deliver results with integrity, and who enjoys finding ways to enhance the lives of others every day.</div><div></div><div>
We&rsquo;ll also want to know you can demonstrate these attributes:</div><ul><li><div>
Strong interpersonal communications (written and verbal) and problem solving skills, ability to multi-task, thrive in a highly cooperative work setting.</div></li><li><div>
Understanding of internet-based performance marketing.</div></li><li><div>
3-5 years&rsquo; experience in government affairs.</div></li><li><div>
3-5 years' experience in the financial services industry preferred.</div></li><li><div>
Demonstrated ability to create effective presentations.</div></li><li><div>
Demonstrated ability to employ tact and diplomacy to foster business relations within and outside of the company.</div></li><li><div>
Proficient in basic computer technologies, appropriate for an internet-based company.</div></li></ul><div></div><div>
Learn more about Veterans United on <div>Glassdoor</div> and our career site at <div>vu.com/careers</div></div><div>
Veterans United Home Loans and its affiliates are Equal Opportunity Employers that consider all qualified applicants regardless of race, color, religion, sex (including pregnancy, transgender status, and sexual orientation), national origin, age (40 or older), disability or genetic information.</div></div>

External Affairs Manager

Gadgeon Medical Systems Pvt Ltd.

<p><b>About Webcardio </b></p><p>Webcardio is a leading provider of innovative cardiac monitoring solutions, offering Doctors and patients real-time, remote cardiac diagnostics through advanced wearable ECG technology. Our mission is to improve cardiac care delivery using AI driven insights and seamless technology.</p><p><b>Role Overview</b></p><p>The Medical Affairs Manager will lead and oversee clinical and medical activities, ensuring high-quality, compliant, and evidence-based clinical research and communication. The role involves managing clinical studies, regulatory compliance, cross-functional collaboration, and scientific communication to support product development, marketing, and sales initiatives.</p><p><b>Key Responsibilities:</b></p><p><b>1. Clinical Study Management</b></p><ul><li>Design, plan, and manage clinical trials, including Real-World Evidence (RWE) studies.</li><li>Ensure adherence to Good Clinical Practices (GCP) and ethical guidelines.</li><li>Collaborate with investigators, Key Opinion Leaders (KOLs), and research sites.</li><li>Collect, analyse, and interpret post-marketing clinical data.</li><li>Conduct retrospective analyses of WebCardio data.</li><li>Lead prospective clinical trials, including protocol design, medical writing, and data analysis to ensure smooth execution.</li></ul><p><b>2. Regulatory &amp; Compliance Oversight</b></p><ul><li>Ensure compliance with regulatory requirements (e.g., CDSCO) and internal standards.</li><li>Prepare clinical documentation for regulatory submissions and approvals.</li><li>Monitor evolving clinical and regulatory standards to ensure ongoing compliance.</li></ul><p><b>3. Cross-Functional Collaboration</b></p><ul><li>Partner with marketing, sales, and other functions to provide clinical insights that enhance strategy and product development.</li><li>Support sales teams in addressing clinical objections with evidence-based information.</li><li>Collaborate with KOLs to gather insights for ongoing and future projects.</li><li>Travel as required to support studies and stakeholder engagement.</li></ul><p><b>4. Scientific &amp; Medical Communication</b></p><ul><li>Prepare clinical study reports, white papers, and publications.</li><li>Present clinical data at conferences, webinars, and to internal and external stakeholders.</li><li>Provide scientific training to KOLs, speakers, and the sales team as required.</li></ul><p><b>Qualifications &amp; Experience:</b></p><ul><li>Degree in Medicine, Pharmacy, or Life Sciences (MBBS,PHD,PharmD, or equivalent).</li><li>Proven experience in clinical study management, medical affairs, or regulatory roles in healthcare/medical device/biotech sectors.</li><li>Strong knowledge of GCP, clinical research methodology, and regulatory requirements.</li><li>Excellent communication, collaboration, and analytical skills.</li><li><b>Place of work- Delhi/NCR (WFH)</b></li><li>Min 3+ Years of experience</li><li>Travel- 25% of time and depends on study requirements.</li></ul><p>Job Types: Full-time, Permanent</p><p>Pay: &#8377;800,000.00 - &#8377;1,200,000.00 per year</p><p>Application Question(s):</p><ul><li>Current CTC</li><li>Expected CTC</li></ul><p>Education:</p><ul><li>Bachelor's (Required)</li></ul><p>Experience:</p><ul><li>clinical study management: 2 years (Required)</li></ul><p>Location:</p><ul><li>Delhi, Delhi (Required)</li></ul><p>Willingness to travel:</p><ul><li>25% (Required)</li></ul><p>Work Location: Remote</p>

Medical Affairs Manager

Besins Healthcare

<p><strong>Key Responsibilities:</strong></p><ul><li>Acts as responsible Regulatory Team member for assigned regulatory projects.</li><li>Preparation and submit Life-Cycle Maintenance regulatory submissions for Africa (English and French Speaking).</li><li>Prepares and/or reviews regulatory documentation for National applications in line with assigned timelines.</li><li>May support on some R&amp;D regulatory projects.</li><li>Actively participates and employs effective communication practices with internal stakeholder (CMC, Supply Chain, Quality, Legal, Clinical, Medical, Pharmacovigilance, and Globally based Regional Regulatory affairs team</li><li>Understands the Scope of Work, timelines and deliverables for a given project.</li><li>Prepare status reports and metrics for assigned projects.</li><li>Perform assigned work according to current best good regulatory practice/guidelines in compliance with current legislation.</li><li>Any other duties as assigned by your manager.</li><li>Learn, develop, and train.</li></ul><p><strong>_Technical Skills/ Experience_</strong></p><ul><li>&gt;4-5 years pharmaceutical regulatory experience, focusing on lifecycle maintenance of marketed products in Africa, Middle East, Asia (e.g. variations, renewals, new Marketing Authorisation Applications (MAAs) submissions)-Europe/Turkey experience is and advantage.</li><li>Preparation of relevant CTD (Common Technical Dossier) documents to support submissions, in collaboration with Technical/CMC/Clinical/Labelling operations.</li><li>Experience of GCC markets/ICH guidelines/MHRA guidelines</li><li>Experience of emerging markets / international RoW markets and regulatory filings.</li><li>Quality control review of technical/ regulatory documents.</li><li>Understanding of Regulatory strategy and determination of documentation requirements. Compliance with SOPs, Change controls and regulatory best practices.</li><li>Publishing: eCTD and or NEES.</li><li>Pharmaceutical artwork review and sign-off.</li><li>Project management experience - an advantage.</li><li>Experience of Women s and/or Men s healthcare   an advantage</li></ul><p><strong>_Soft Skills_</strong></p><ul><li>Ability to work to tight timelines and manage peaks in workload.</li><li>Good team player with internationally based colleagues in Global Pharmaceutical Affairs team.</li><li>Positive can-do attitude in growing company with expanding range of therapeutic product range.</li><li>Good negotiating skills and the ability to identify and resolve issues with external stakeholders.</li><li>Excellent verbal and written communication skills.</li><li>Excellent computer skills e.g. Word, Excel, data and document management systems.</li><li>Cultural awareness for global ways of working.</li><li>Able to act as a mentor to junior colleagues and to assist in their training and development as appropriate.</li><li>Desire to grow regulatory operational and regulatory strategy experience.</li><li>Languages: Speaking &amp; Writing  French  is a Must- Fluent Arabic/English Required as well.</li></ul><p><strong>_Minimum required education and experience_</strong></p><ul><li>Degree in Pharmacy or life science-related degree plus at least 4-5 year s relevant human pharmaceutical experience with focus on filing and lifecycle maintenance of marketed products in Middle East/ Africa/Asia</li></ul>

Regulatory Affairs Officer

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