Associate Director of Regulatory Affairs
Company Name:
Arca24.com
Salary period: Annual
We seek for a leading biopharmaceutical company localized in Amsterdam for a
Associate Director of Regulatory Affairs
Essential Duties of this role are
Leading all regulatory activities for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
Ensuring responsibilities of Applicant and/or License Holder defined in legislation or regulatory guidances are met for assigned product(s) and territories.
Prepare and/or manage others' submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs.
Responsible for submitting or ensuring submission of all regulatory documents required to obtain and maintain clinical trial applications and marketing authorizations for assigned product(s) and territories.
Responsible for reviewing and approving promotional and non-promotional activities and materials and ensuring their compliance with local guidance, Codes of conduct and SOPs
Assisting local business initiatives including market access, business compliance and medical lead projects
Responsible for compliance with GDP and ensuring Responsible Person activities are performed according to local regulatory requirements
Active participation in leadership team meetings for the local business and regulatory function, contributing to strategic decisions for a multitude of projects and initiatives ranging from submission strategies to local business operations
Responsible for ensuring any updates to the Company Core Data Sheet (CCDS) or Company Core Safety Information (CCSI) are implemented in a timely manner.
Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product license.
Acts as project team representative or lead on European or International projects.
Represents Regulatory Function at internal and external meetings. Works proactively to build contacts with local Regulatory Authorities and build upon an existing network of regulatory contacts.
Participates in industry trade groups and regulatory affairs professional societies. Maintains knowledge of highly complex regulatory requirements up to date, contribute to preparation of new regulatory guidance wherever possible, comments on draft regulatory guidance and communicates changes in regulatory information to project teams and senior management.
Initiates or contributes to local and / or global process improvements which have a significant impact on the business.
Requirements
Candidate must possess strong leadership skills and strategic thinking capabilities
Broad Regulatory Affairs experience
Experience being a main contact for regulatory agencies
Strong business acumen (able to liaise with both Marketing and Medical divisions of the client)
Experience with Market Access
GxP knowledge
Ideally, you have 10-15 years of working experience
Role is office based 5 days a week
last but not least, fluency in Dutch, French and English is required.
Offer
Salary indication is approximately 130000 gross a year
You will be hired as a permanent employee
You receive a bonus of 20% by good performance
You will be working in an international environment
You are allowed to work at home several days/week
Company
This leading biopharmaceutical company was founded in the United States and since 1985 expanded internationally with approximately 5,000 employees in offices across the globe. Through their research and development contribution, they have more than 75 compounds being evaluated in a phase 2 and 3 clinical study with the potential to become the next generation of innovative therapies for HIV, hepatitis, serious respiratory, cardiovascular and metabolic conditions, cancer and inflammation.
Interested in the position of Associate Director of Regulatory Affairs?
Apply via our website or call Tanja Bos for more information (023-).
Job Location in the Country: Noord Holland
Employment Type: Permanent
Category: Medical/Health;
Quality Assurance/Safety;
Science
Date Posted: 8/6/14
Work Type: Full time (100%)
Job Number: JO-1408-13334
Division Description: Kelly Scientific Resources is een toonaangevende loopbaanadviseur voor professionals binnen de Life Science, Chemie, Food en Milieu. Sinds onze oprichting in 1995 is onze organisatie uitgegroeid tot een wereldwijd netwerk van gespecialiseerde recruiters met veel contacten bij interessante werkgevers bij u in de omgeving. Als u op zoek bent naar een nieuwe baan, dan kan Kelly Scientific Resources een waardevolle partner zijn tijdens het ori nteren op de mogelijkheden binnen chemische, farmaceutische of biotechnologische industrie. Wij bieden diverse loopbaanmogelijkheden en zorgen voor deskundige begeleiding tijdens uw sollicitiaties zodat u de baan krijgt die het beste bij u past.Estimated Salary: $20 to $28 per hour based on qualifications.
Arca24.com
Salary period: Annual
We seek for a leading biopharmaceutical company localized in Amsterdam for a
Associate Director of Regulatory Affairs
Essential Duties of this role are
Leading all regulatory activities for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
Ensuring responsibilities of Applicant and/or License Holder defined in legislation or regulatory guidances are met for assigned product(s) and territories.
Prepare and/or manage others' submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs.
Responsible for submitting or ensuring submission of all regulatory documents required to obtain and maintain clinical trial applications and marketing authorizations for assigned product(s) and territories.
Responsible for reviewing and approving promotional and non-promotional activities and materials and ensuring their compliance with local guidance, Codes of conduct and SOPs
Assisting local business initiatives including market access, business compliance and medical lead projects
Responsible for compliance with GDP and ensuring Responsible Person activities are performed according to local regulatory requirements
Active participation in leadership team meetings for the local business and regulatory function, contributing to strategic decisions for a multitude of projects and initiatives ranging from submission strategies to local business operations
Responsible for ensuring any updates to the Company Core Data Sheet (CCDS) or Company Core Safety Information (CCSI) are implemented in a timely manner.
Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product license.
Acts as project team representative or lead on European or International projects.
Represents Regulatory Function at internal and external meetings. Works proactively to build contacts with local Regulatory Authorities and build upon an existing network of regulatory contacts.
Participates in industry trade groups and regulatory affairs professional societies. Maintains knowledge of highly complex regulatory requirements up to date, contribute to preparation of new regulatory guidance wherever possible, comments on draft regulatory guidance and communicates changes in regulatory information to project teams and senior management.
Initiates or contributes to local and / or global process improvements which have a significant impact on the business.
Requirements
Candidate must possess strong leadership skills and strategic thinking capabilities
Broad Regulatory Affairs experience
Experience being a main contact for regulatory agencies
Strong business acumen (able to liaise with both Marketing and Medical divisions of the client)
Experience with Market Access
GxP knowledge
Ideally, you have 10-15 years of working experience
Role is office based 5 days a week
last but not least, fluency in Dutch, French and English is required.
Offer
Salary indication is approximately 130000 gross a year
You will be hired as a permanent employee
You receive a bonus of 20% by good performance
You will be working in an international environment
You are allowed to work at home several days/week
Company
This leading biopharmaceutical company was founded in the United States and since 1985 expanded internationally with approximately 5,000 employees in offices across the globe. Through their research and development contribution, they have more than 75 compounds being evaluated in a phase 2 and 3 clinical study with the potential to become the next generation of innovative therapies for HIV, hepatitis, serious respiratory, cardiovascular and metabolic conditions, cancer and inflammation.
Interested in the position of Associate Director of Regulatory Affairs?
Apply via our website or call Tanja Bos for more information (023-).
Job Location in the Country: Noord Holland
Employment Type: Permanent
Category: Medical/Health;
Quality Assurance/Safety;
Science
Date Posted: 8/6/14
Work Type: Full time (100%)
Job Number: JO-1408-13334
Division Description: Kelly Scientific Resources is een toonaangevende loopbaanadviseur voor professionals binnen de Life Science, Chemie, Food en Milieu. Sinds onze oprichting in 1995 is onze organisatie uitgegroeid tot een wereldwijd netwerk van gespecialiseerde recruiters met veel contacten bij interessante werkgevers bij u in de omgeving. Als u op zoek bent naar een nieuwe baan, dan kan Kelly Scientific Resources een waardevolle partner zijn tijdens het ori nteren op de mogelijkheden binnen chemische, farmaceutische of biotechnologische industrie. Wij bieden diverse loopbaanmogelijkheden en zorgen voor deskundige begeleiding tijdens uw sollicitiaties zodat u de baan krijgt die het beste bij u past.Estimated Salary: $20 to $28 per hour based on qualifications.
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