Regulatory affair Manager
vor 3 Wochen
Job Description: As a Regulatory Affairs Manager, you will be responsible for ensuring compliance with regulatory requirements related to the development, approval, and marketing of pharmaceutical, medical device, or other healthcare products. You will work closely with cross-functional teams to navigate the complex regulatory landscape and to ensure that products meet all applicable regulations and standards.
Responsibilities:
- Develop and implement regulatory strategies for product development, registration, and commercialization.
- Prepare and submit regulatory submissions, including Investigational New Drug (IND), New Drug Application (NDA), 510(k), Pre-Market Approval (PMA), or other regulatory filings, as required.
- Liaise with regulatory agencies, such as the FDA, EMA, or other regulatory authorities, to facilitate the review and approval process for new products or product changes.
- Provide regulatory guidance and support to cross-functional teams, including R&D, Clinical Affairs, Quality Assurance, and Marketing, to ensure compliance with regulatory requirements throughout the product lifecycle.
- Monitor and interpret changes in regulations and guidelines and communicate potential impact to relevant stakeholders.
- Manage regulatory documentation and maintain regulatory compliance records.
- Participate in regulatory audits and inspections as needed.
- Represent the company in regulatory interactions and meetings with regulatory agencies.
Qualifications:
- Bachelor's degree in a scientific or healthcare-related field; advanced degree (e.g., Master's or PhD) preferred.
- Minimum of [X] years of experience in regulatory affairs within the pharmaceutical, medical device, or healthcare industry.
- Strong understanding of regulatory requirements and guidelines, including FDA regulations (21 CFR), ICH guidelines, and other applicable regulations.
- Experience with regulatory submissions, including INDs, NDAs, 510(k)s, PMAs, or other regulatory filings.
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and regulatory agencies.
- Detail-oriented with strong analytical and problem-solving skills.
- Ability to manage multiple projects simultaneously and prioritize tasks in a fast-paced environment.
- Regulatory Affairs Certification (RAC) preferred.
-
Community Manager/in Affaires D'entreprises
vor 1 Monat
Lausanne, Schweiz AXA Versicherungen Vollzeit80-100% Lieu de travail: Lausanne/ Winterthur/ Smart working Tu es une personne résistante, motivée et qui a de l'expérience dans le domaine de l'assurance! Alors c'est toi que nous recherchons! En tant que Community Manager/in Affaires d'entreprises, tu favorises le développement professionnel de la force de vente pour les affaires d'entreprises P&C...
-
Regulatory Affairs Manager
vor 1 Woche
Le Mont-sur-Lausanne, Schweiz RegenLab SA VollzeitRegen Lab SA based in Le Mont-sur-Lausanne. We are a Swiss leading medical device company comprised of a dynamic team dedicated to revolutionizing healthcare. Our commitment to innovation and excellence drives us to develop cutting-edge medical devices that positively impact patients' lives worldwide.Regulatory Affairs ManagerPosition Overview:For our...
-
Regulatory Affairs Manager
Vor 7 Tagen
Le Mont-sur-Lausanne, Schweiz RegenLab SA VollzeitRegen Lab SA based in Le Mont-sur-Lausanne. We are a Swiss leading medical device company comprised of a dynamic team dedicated to revolutionizing healthcare. Our commitment to innovation and excellence drives us to develop cutting-edge medical devices that positively impact patients' lives worldwide.Regulatory Affairs ManagerPosition Overview:For our site...
-
Regulatory Affairs Manager
vor 1 Woche
Le Mont-sur-Lausanne, Schweiz RegenLab SA Vollzeit#slim #content {border: none;margin: 0;padding: 0;} #slim .slim_picture {text-align: left;margin: 0 10px 20px 0;} #slim .slim_picture img {max-height: 126px;} #slim .slim_content {border: none;} #slim .slim_title {font-size: 24px;font-weight: bold;margin: 0 0 10px 0;text-align: left;line-height: 32px;word-wrap: break-word;} #slim .slim_text {padding: 0...
-
EMEA Regulatory Affairs Specialist
Vor 4 Tagen
Lausanne, Schweiz LHH VollzeitLHH Recruitment Solutions is a specialized talent recruitment boutique. We provide tailored services to help companies find the best candidates for their staffing needs. With deep industry expertise and a commitment to excellence, LHH RS is a trusted partner in Switzerland for many years.Our client is an international company located in Canton of...
-
EMEA Regulatory Affairs Specialist
Vor 5 Tagen
Lausanne, Schweiz Adecco Human Resources AG VollzeitLHH Recruitment Solutions is a specialized talent recruitment boutique. We provide tailored services to help companies find the best candidates for their staffing needs.With deep industry expertise and a commitment to excellence, LHH RS is a trusted partner in Switzerland for many years.Our client is an international company located in Canton of...
-
Capex Project Manager
vor 1 Monat
Lausanne, Schweiz Capgemini Engineering Vollzeit**About Us**: At Capgemini Engineering Switzerland we value excellence, diligence, responsibility, dynamism and innovation. We offer a diverse workplace and would like to invite you to be part of our success story where we provide training, tools and foundations for your professional and personal growth. We are looking for an experienced CAPEX Project...
-
Capex Project Manager
vor 1 Monat
Lausanne, Schweiz Capgemini Engineering Vollzeit**About Us**: At Capgemini Engineering Switzerland we value excellence, diligence, responsibility, dynamism and innovation. We offer a diverse workplace and would like to invite you to be part of our success story where we provide training, tools and foundations for your professional and personal growth. We are looking for an experienced CAPEX Project...
-
CAPEX Project Manager
vor 1 Monat
Lausanne, Schweiz Capgemini VollzeitAbout Us At Capgemini Engineering Switzerland we value excellence, diligence, responsibility, dynamism and innovation. We offer a diverse workplace and would like to invite you to be part of our success story where we provide training, tools and foundations for your professional and personal growth. We are looking for an experienced CAPEX Project...
-
CAPEX Project Manager
vor 1 Monat
Lausanne, Schweiz Capgemini VollzeitAbout UsAt Capgemini Engineering Switzerland we value excellence, diligence, responsibility, dynamism and innovation. We offer a diverse workplace and would like to invite you to be part of our success story where we provide training, tools and foundations for your professional and personal growth. We are looking for an experienced CAPEX Project Manager.Job...
-
Accounting Manager
vor 1 Woche
Lausanne, Schweiz LHH VollzeitOur client is a Swiss small-medium size company located in Lausanne, now with a new opening of Accounting Manager **Responsibilities**: - Manage and develop a small team of accountants - Ensure compliance with accounting principles and applicable regulations, laws and standards - Ensure the quality and timely execution of month-end closing and reporting as...
-
Area Sales Manager
vor 1 Monat
Lausanne, Schweiz Careerplus VollzeitLes vins et spiriteux n'ont plus aucun secret pour vous en Suisse romande ? Cette opportunité est faite pour vous ! Pour notre client, une entreprise dans le domaines des vins et spiritueux, nous recherchons un Area Sales Manager pour la Suisse romande. **Vos activités chez votre futur employeur** - Vous développez et fidélisez un portefeuille client...
-
QA Manager Biologics
Vor 5 Tagen
Lausanne, Schweiz AXEPTA SA VollzeitOur client based in the canton of Vaud is currently seeking a Biologics QA Manager to strengthen their team following an increase in activity. This assignment will be for a minimum duration of 6 months due to the company's growth.This person will oversee the quality of clinical and commercial manufacturing and testing activities at CMOs for assigned...
-
QA Manager Biologics
Vor 5 Tagen
Lausanne, Schweiz AXEPTA SA VollzeitOur client based in the canton of Vaud is currently seeking a Biologics QA Manager to strengthen their team following an increase in activity. This assignment will be for a minimum duration of 6 months due to the company's growth.This person will oversee the quality of clinical and commercial manufacturing and testing activities at CMOs for assigned...
-
QA Manager Biologics
Vor 5 Tagen
Lausanne, Schweiz Axepta SA VollzeitQA Manager Biologics Our client based in the canton of Vaud is currently seeking a Biologics QA Manager to strengthen their team following an increase in activity. This assignment will be for a minimum duration of 6 months due to the company's growth.This person will oversee the quality of clinical and commercial manufacturing and testing activities at...
-
CAPEX Project Manager
vor 2 Monaten
Lausanne greater area, Schweiz Capgemini Suisse SA VollzeitAbout Us At Capgemini Engineering Switzerland we value excellence, diligence, responsibility, dynamism and innovation. We offer a diverse workplace and would like to invite you to be part of our success story where we provide training, tools and foundations for your professional and personal growth. We are looking for an experienced CAPEX Project...
-
Quality Assurance Manager
vor 4 Wochen
Lausanne, Schweiz Limula VollzeitLimula SA is a Life Science start-up based in Lausanne, Switzerland. Our company was established with _the mission to help bring the most personalised cancer treatments to the patients in need, at reasonable _cost, wherever they are. To achieve this goal, our multidisciplinary team provides a unique cell processing _solution that enables the production of...
-
Manager Accounting
vor 1 Monat
Lausanne, Schweiz Brodard Executive Search VollzeitDescription du poste For one of our client, a sizable company operating mainly in Switzerland, located in the Lausanne area. We are looking for a **Manager Accounting & Tax - to join the Finance department.As Manager Accounting & Tax, you will actively take part in the management of Finance and Accounting operations for the group. The Manager Accounting &...
-
Computerized System Validation Engineer
vor 1 Monat
Lausanne, Schweiz Capgemini VollzeitAbout Us At Capgemini Engineering Switzerland we value excellence, diligence, responsibility, dynamism and innovation. We offer a diverse workplace and would like to invite you to be part of our success story where we provide training, tools and foundations for your professional and personal growth. We are looking for an experienced (Computerized...
-
Computerized System Validation Engineer
vor 1 Monat
Lausanne, Schweiz Capgemini VollzeitAbout Us At Capgemini Engineering Switzerland we value excellence, diligence, responsibility, dynamism and innovation. We offer a diverse workplace and would like to invite you to be part of our success story where we provide training, tools and foundations for your professional and personal growth. We are looking for an experienced (Computerized System...