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Associate Director Regulatory Affairs. Job in Maidenhead, United Kingdom in Biogen. Nelest.com
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Associate Director Regulatory Affairs

col-narrow-left   

Job ID:

23157

Location:

Maidenhead 

Job function:

Business Development, Legal Services
col-narrow-right   

Posted:

03.11.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Associate Director Regulatory Affairs

Job Description:

The Regulatory Global Emerging Markets Regional Head (GRH) will provide leadership and strategic direction for a defined Emerging Market region and be the Emerging Market Regulatory Leader for one or more key product assets. The GRH role will be primarily responsible for the following:

- Define and ensure execution of regional development, labeling and content strategies for all products (e.g., new marketing applications and lifecycle maintenance) with defined GEM region.

- Be the Emerging Market leader for defined products and ensure GEM product strategy is factored into Global Product Development Strategy

- Oversight of Vendor performance, execution, define and share metrics and thresholds for vendor performance of operational activities

- Represents the company and proactively fosters excellent working relationships with International regulatory authorities, trade associations distributors, contractors and corporate partners

- Oversee and support due diligence activities and inspective readiness
The GRH must demonstrate strategic and innovative agility, high level of business acumen, and have the ability to lead and define the regional Regulatory strategy. This position also participates in capability building initiatives and contributes to the strategies and vision for the larger Regulatory Affairs organization as well as Development Sciences and the Emerging Markets business.
1. Define and ensure execution of regional development, labeling and content strategies for all products (e.g., new marketing applications and lifecycle maintenance) within defined Emerging Market Region.
2. Is the Company subject matter expert in Emerging Market Regulatory Affairs and designated region,
a. Identify and assess regulatory risks associated with product development and lifecycle maintenance in region. Define strategies to mitigate risks.
b. Provide Emerging Market regulatory guidance to company personnel throughout the research & development and commercial lifecycle process.
c. Support the organization, affiliates and distributors for effective and accurate regulatory submission processes, review and approval.
d. Prepare and deliver effective presentations for external and internal audience.
e. Monitor and analyze appropriate regulatory agency and trade association activities in region and key areas of business interest to the company
3. Oversight of vendor performance, execution, define share and oversee metrics and thresholds for vendor performance of operational activities and accuracy for submissions
4. Serve as GEM Regulatory Lead on defined Regulatory Project Team(s), Program Teams and cross-functional teams to ensure GEM product strategy is factored into Global Product Development Strategies
5. Emerging Market Regulatory Leadership
a. Build and maintain excellent relationships with regional Emerging Market regulatory agencies, distributors, contractors and corporate partners whilst representing the agreed company positioning.
b. Help shape the strategic vision for the region, affiliate build and distributor presence to meet current and future needs of the business.
c. Provide regional Emerging Market regulatory leadership in policy setting teams, committees and Trade Associations.
d. Active member and contributor to the International Regulatory Leadership Team, and represent the Head of Emerging Market Regulatory Affairs on Management Teams as needed.
6. Oversee and support due diligence and inspection readiness activities

*LI-EU4

Job Requirements:

Qualifications
- Minimum of 5 years Regulatory experience, including 3+ years' experience in Emerging Market Regulatory Affairs
- Comprehensive knowledge of global and emerging market applicable regulations.
- Experience in interpretation of global and emerging market regulations, guidelines, policy statements, etc.
- Experience and knowledge in the preparation of global and emerging market assessment of major regulatory submissions and supportive amendments or supplements.
- Significant experience in interfacing with Emerging Market regulatory authorities
- Strong management skills, and ability to effectively lead and collaborate with various business functions
- High attention to detail including proven ability to manage multiple, competing priorities Education
- BA/BS/University degree required, Life/Health Sciences preferred.
- 10 years pharmaceutical/biotechnology industry experience with technical management experience About BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic conditions and autoimmune diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.

Founded in 1978, Biogen is one of the world's oldest biotechnology companies. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for secondary progressive MS, Alzheimer's Disease, spinal muscular atrophy, lupus and amyotrophic lateral sclerosis (ALS), amongst others.

With approximately 7,500 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

Please be advised that all legitimate correspondence from a Biogen employee will come from '@biogen.com' or '@biogenidec.com' email accounts.

Company Info
Biogen

Cambridge, MA, United States

Phone: +1 781-464-3260, +1 781-464-3260
Web Site: www.biogene.com

Company Profile

Company Info


Biogen
Cambridge, MA, United States
Phone: +1 781-464-3260, +1 781-464-3260
Web Site: www.biogene.com

Associate Director Regulatory Affairs

col-narrow-left   

Job ID:

23157

Location:

Maidenhead 

Job function:

Business Development, Legal Services
col-narrow-right   

Posted:

03.11.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Associate Director Regulatory Affairs

Job Description:

The Regulatory Global Emerging Markets Regional Head (GRH) will provide leadership and strategic direction for a defined Emerging Market region and be the Emerging Market Regulatory Leader for one or more key product assets. The GRH role will be primarily responsible for the following:

- Define and ensure execution of regional development, labeling and content strategies for all products (e.g., new marketing applications and lifecycle maintenance) with defined GEM region.

- Be the Emerging Market leader for defined products and ensure GEM product strategy is factored into Global Product Development Strategy

- Oversight of Vendor performance, execution, define and share metrics and thresholds for vendor performance of operational activities

- Represents the company and proactively fosters excellent working relationships with International regulatory authorities, trade associations distributors, contractors and corporate partners

- Oversee and support due diligence activities and inspective readiness
The GRH must demonstrate strategic and innovative agility, high level of business acumen, and have the ability to lead and define the regional Regulatory strategy. This position also participates in capability building initiatives and contributes to the strategies and vision for the larger Regulatory Affairs organization as well as Development Sciences and the Emerging Markets business.
1. Define and ensure execution of regional development, labeling and content strategies for all products (e.g., new marketing applications and lifecycle maintenance) within defined Emerging Market Region.
2. Is the Company subject matter expert in Emerging Market Regulatory Affairs and designated region,
a. Identify and assess regulatory risks associated with product development and lifecycle maintenance in region. Define strategies to mitigate risks.
b. Provide Emerging Market regulatory guidance to company personnel throughout the research & development and commercial lifecycle process.
c. Support the organization, affiliates and distributors for effective and accurate regulatory submission processes, review and approval.
d. Prepare and deliver effective presentations for external and internal audience.
e. Monitor and analyze appropriate regulatory agency and trade association activities in region and key areas of business interest to the company
3. Oversight of vendor performance, execution, define share and oversee metrics and thresholds for vendor performance of operational activities and accuracy for submissions
4. Serve as GEM Regulatory Lead on defined Regulatory Project Team(s), Program Teams and cross-functional teams to ensure GEM product strategy is factored into Global Product Development Strategies
5. Emerging Market Regulatory Leadership
a. Build and maintain excellent relationships with regional Emerging Market regulatory agencies, distributors, contractors and corporate partners whilst representing the agreed company positioning.
b. Help shape the strategic vision for the region, affiliate build and distributor presence to meet current and future needs of the business.
c. Provide regional Emerging Market regulatory leadership in policy setting teams, committees and Trade Associations.
d. Active member and contributor to the International Regulatory Leadership Team, and represent the Head of Emerging Market Regulatory Affairs on Management Teams as needed.
6. Oversee and support due diligence and inspection readiness activities

*LI-EU4

Job Requirements:

Qualifications
- Minimum of 5 years Regulatory experience, including 3+ years' experience in Emerging Market Regulatory Affairs
- Comprehensive knowledge of global and emerging market applicable regulations.
- Experience in interpretation of global and emerging market regulations, guidelines, policy statements, etc.
- Experience and knowledge in the preparation of global and emerging market assessment of major regulatory submissions and supportive amendments or supplements.
- Significant experience in interfacing with Emerging Market regulatory authorities
- Strong management skills, and ability to effectively lead and collaborate with various business functions
- High attention to detail including proven ability to manage multiple, competing priorities Education
- BA/BS/University degree required, Life/Health Sciences preferred.
- 10 years pharmaceutical/biotechnology industry experience with technical management experience About BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic conditions and autoimmune diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.

Founded in 1978, Biogen is one of the world's oldest biotechnology companies. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for secondary progressive MS, Alzheimer's Disease, spinal muscular atrophy, lupus and amyotrophic lateral sclerosis (ALS), amongst others.

With approximately 7,500 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

Please be advised that all legitimate correspondence from a Biogen employee will come from '@biogen.com' or '@biogenidec.com' email accounts.
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