Senior Regulatory Affairs Manager
Katalyst Healthcares and Life Sciences
Responsibilities:
Requirements:
- Support the Senior Director in developing and executing regional regulatory strategies for QOL
- initiatives within specific regions.
- Contribute to providing strategic oversight and leadership to the regulatory team, ensuring alignment with company objectives and regional regulatory requirements.
- Participate in the preparation and submission of regulatory documents related to QOL initiatives to regulatory authorities.
- Collaborate with cross-functional teams to integrate QOL considerations into product development, manufacturing, and commercialization processes.
- ssist in fostering relationships with regional regulatory authorities to facilitate communication, negotiations, and interactions related to QOL initiatives.
- Stay informed about regulatory developments, changes, and trends within specific regions, and provide insights to the Senior Director and Associate Director.
- Contribute to managing regulatory risks and opportunities related to QOL initiatives and assist in developing mitigation strategies as needed.
- Provide regulatory guidance and support for post-marketing activities related to QOL initiatives, Including variations, renewals, labeling updates, and compliance initiatives.
- Collaborate with the regulatory team to represent the company's interests in industry forums, working groups, and regulatory meetings related to QOL initiatives.
- Support coordination with global regulatory counterparts to ensure alignment of regional regulatory strategies and submissions with global development plans and corporate objectives.
- ssist in preparing regulatory updates, progress reports, and strategic recommendations for senior and/or executive leadership and regulatory governance committees.
- ssists in preparing and organizing all necessary documentation required for regulatory inspections and inspection readiness initiatives ensuring completeness, accuracy, and accessibility of records related to QOL initiatives.
- Participates in facilitating communication, providing requested documentation, and addressing any questions or concerns raised by the inspection readiness team in a timely and professional manner.
Requirements:
- Bachelor's degree in a scientific discipline such as life sciences, pharmacy, bioscience; advanced degree preferred.
- 5+ years of experience in regulatory affairs within the pharmaceutical or biotech industry, with a focus on quality-of-life products preferred.
- Must have branded product reg affairs experience
- Demonstrated ability to work effectively in a cross-functional team environment.
- Strong knowledge of regional regulatory requirements and guidelines, including FDA regulations and ICH guidelines.
- Excellent communication and interpersonal skills.
- bility to assist in developing and executing regulatory strategies tailored to specific regions.
- Strong organizational skills with attention to detail.
- bility to collaborate effectively with cross-functional teams.
- Knowledge of regulatory submissions and documentation processes.
- wareness of regulatory developments and trends within specific regions.
- Strong analytical and problem-solving skills.
- bility to work independently and prioritize tasks effectively.
- bility and willingness to travel approximately 10% of the year both domestically and internationally .
Vacancy posted 5 days ago
Similar jobs that could be interesting for youBased on the Senior Regulatory Affairs Manager in Columbia, MD vacancy
$139.24k - $224.48k
TCOM, L.P. is seeking a Director, Contracts in Columbia, Maryland. This role leads the contracts department and manages complex government, commercial, and international contract issues. Candidates should possess a Bachelor's degree and have at least 15 years of contracts...SeniorContract work$105k - $130k
...advance housing policy at every level of government, and build and manage communities ourselves. Since 1982, we have invested $80.9... ...Enterprise is happy to announce our search for a newly added position of Senior Manager, Tax & Compliance. The Senior Manager, Tax & Compliance...SeniorWork at officeFlexible hours1 day per week- ...Columbia, Maryland is looking for experienced Commercial Real Estate Agents. The ideal candidates will excel in client relationship management and have strong sales skills. The company offers a collaborative culture, extensive training, and resources to ensure agents can...SeniorRemote work
$110k - $130k
HazTek Inc in Laurel, Maryland is seeking an experienced Safety Manager to oversee safety operations on commercial construction projects. You will ensure compliance with OSHA standards and lead efforts to create a safety-focused culture within the team. The ideal candidate...Senior$100k - $130k
A leading construction firm in Columbia, MD is seeking experienced leaders in design and construction to manage complex projects. The role requires ten or more years of experience, particularly in architectural and building envelope systems. Responsibilities include owner...SeniorFull time$80.34k - $145.08k
...visit covista.com and follow us on LinkedIn , Instagram and YouTube . Job Description Opportunity at a Glance The Senior Manager, Experience Strategy & Web Performance is the designated owner of institutional web channel(s), accountable for end-to-end...SeniorFull timeWork at officeFlexible hoursCovista
Columbia, MD3 days ago$140k - $165k
A national nonprofit organization based in Columbia, Maryland is seeking a Workplace Experience & Space Optimization leader to design and implement workplace strategies. The ideal candidate will have over 10 years of leadership experience in real estate or workplace services...SeniorFlexible hours$160k - $205k
Johns Hopkins Medicine in Columbia, Maryland is seeking a Director of Facilities Management responsible for overseeing a facilities management division at Howard County Medical Center. This role involves leading engineering teams, developing strategies for efficient service...Senior$190k - $210k
...excited to potentially welcome you as part of our team as we continue to grow on a worldwide scale. About the Role The Senior Strategic Sourcing Manager is the highest-level individual contributor on Tate’s liquid cooling procurement team. This person is most responsible...SeniorFull timeContract workWork at officeRemote workWorldwideShift work- ...Manger is responsible for all multifamily compliance functions including organizing and directing these activities for the Portfolio Management division. The primary responsibility of the position is to oversee all compliance related activity for the operation of the...For contractorsWork at officeLocal area
District of Columbia Housing Finance Agency
Columbia, MD5 days ago - ...MANTECH seeks a motivated, career and customer-oriented Senior Cyber Intelligence Analyst to join our team in the Annapolis Junction... ...machinery, etc. Frequently communicates with co-workers, management, and customers, which may involve delivering presentations....SeniorWork at office
MANTECH
Annapolis Junction, MD3 hours ago - A leading vision care provider is seeking a part-time Sr. Optical Specialist to deliver exceptional customer service in-store. The ideal candidate will possess at least 12 months of optical experience or an ABO Certification, along with a passion for helping customers ...SeniorPart time
Visionworks
Columbia, MD5 days ago - PLEX Solutions, LLC is seeking a Hardware Engineer to support a program in the Columbia, MD area. The ideal candidate will develop and implement comprehensive verification strategies, including formal methods for complex FPGA designs in high-assurance applications. This...Senior
PLEX Solutions, LLC
Columbia, MD2 days ago - ...ManTech seeks a highly motivated, career and client-oriented Senior Policy Analyst (Artificial Intelligence) to join our Data and AI... ...and its missions Knowledge of Federal legislative and regulatory processes related to AI. Excellent research, analytical, and...SeniorFull timeFlexible hours
MANTECH
Columbia, MD3 hours ago $101.9k - $169.8k
...Fulton Bank, N.A. is seeking an Appraisal Manager to provide support and perform independent internal reviews of appraisal reports for compliance. The role requires a Bachelor's degree and significant appraisal and banking experience. Primary responsibilities include overseeing...SeniorRemote workFulton Bank, N.A.
Columbia, MD21 hours ago- ...implement and maintain automation scripts and configurations using SaltStack to streamline infrastructure provisioning, configuration management and deployment processes. Desired familiarity with tools like Terraform, Salt, Ansible and BigFix to automate provisioning...SeniorFull timeWork at office
MANTECH
Annapolis Junction, MD3 hours ago - ROHDE & SCHWARZ GmbH & Co. KG in Columbia, Maryland, is looking for a cybersecurity expert to perform detailed assessments of ATC systems and ensure compliance with various security frameworks. The ideal candidate will map controls, identify deficiencies, and design secure...Senior
- ...in Columbia, MD is seeking an Executive Assistant to support its leadership team. This role involves overseeing complex calendar management, travel arrangements, and preparing detailed correspondence. The ideal candidate will have strong organizational skills and at least...Senior
Underwriters Laboratories
Columbia, MD2 days ago - .... Research fundamental tax issues using online tools. Perform other accounting duties as needed in engagements and as assigned by managers. Train and develop Staff Accountants. Communicate with managers, partners, and clients. CPA Certified or the eligibility to work towards...Senior
360 Headhunter
Annapolis Junction, MD3 days ago - ...administration and support for Windows Server 2019 and 2022 environments, including Active Directory, DNS, Certificate Authorities and manage Windows 10/11 client systems. Administer and troubleshoot various Linux distributions (e.g., RHEL8/9, AmazonLinux 2023) within...SeniorFull timeWork at office
MANTECH
Annapolis Junction, MD3 hours ago - ...Senior Financial Analyst Industry leading manufacturer is looking for a Financial Analyst that will produce the monthly operating... ...expense reporting package and present to leadership and department managers. You'll be responsible for creating dashboards, budget versus...Senior
Cornerstone Recruiting
Columbia, MD4 days ago - Charles Schwab is looking for a Financial Consultant in Columbia, Maryland. In this role, you will provide wealth management and financial planning advice to clients while fostering strong relationships. Candidates must hold a FINRA Series 7 license and be open to obtaining...Senior
- W. R. Grace in Columbia, MD is seeking a Senior Strategic Marketing Manager for the Materials Technologies team. This role involves driving growth initiatives and leading the development of strategic marketing plans. The ideal candidate will have over 10 years of experience...Senior
$125k - $145k
A technology solutions provider in Annapolis Junction, MD is seeking a System Administrator to provide Tier-3 operational support for IT and monitoring systems. The ideal candidate will ensure system availability and security compliance while administering monitoring tools...Senior$75k - $100k
A real estate team in Columbia, Maryland is looking for experienced real estate agents to join their team. The role emphasizes leveraging technology to streamline tasks and focuses on personal and professional growth. The ideal candidate has 5 to 10 years of experience ...Senior- A cybersecurity solutions provider is seeking a skilled professional for a role focused on verifying and validating the security compliance of information systems. The successful candidate will conduct evaluations, provide comprehensive security assessments, and assist ...Senior
- Solatube is seeking a Senior Strategic Sourcing Manager to shape the global supply chain for our liquid cooling division. This individual will manage complex programs, build supplier relationships, and lead procurement strategies to ensure supply security. With a focus...SeniorRemote job
$100k
Aksarben Heating, Air Conditioning, Plumbing is looking for experienced HVAC Lead Installers in Columbia, Maryland. This full-time, year-round position involves installing residential heating and air conditioning systems, leading installations with assistance from a helper...SeniorFull time- A cybersecurity and technology firm in Columbia, MD, is seeking a skilled Reverse Engineer to support mission-critical contracts in the cybersecurity realm. The ideal candidate will analyze malicious binaries, aiding in malware detection and mitigation. Strong experience...Senior
$70k - $100k
Jobot is seeking a seasoned Estimator to join our dynamic team in Columbia, Maryland. The role involves working on diverse construction projects, utilizing expertise in project estimation and blueprint reading. The ideal candidate will have a minimum of 3 years of experience...Senior
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Regulatory Affairs Manager. Be the first to apply!
Related searches
- compliance director Columbia, MD
- head compliance Columbia, MD
- regulatory manager Columbia, MD
- regulatory affairs director Columbia, MD
- manager regulatory affairs Columbia, MD
- compliance manager Columbia, MD
- regulatory & compliance manager Columbia, MD
- senior data management analyst Columbia, MD
- senior game producer Columbia, MD
- senior manager quality engineering Columbia, MD