1,265 Regulatory Affairs Director jobs in India

Regulatory Affairs Associate Director

Hyderabad, Andhra Pradesh Amgen

Posted 17 days ago

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Job Description

**ABOUT AMGEN**
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
Role description:
Amgen is seeking a Regulatory Affairs Associate Director supporting lifecycle management for approved, mature products across all Amgen Therapeutic Areas. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules. In this important, product-facing role you will lead assigned Global Regulatory Teams (GRT) in the Regulatory Affairs organization.
The role of the Regulatory Affairs Associate Director is to lead GRTs within Amgen's GRAAS organization, develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements, maintain compliance with global registrations, maintain labeling, oversee effective regulatory agency interactions, and provide regulatory expertise and guidance to product teams.
Key Responsibilities:
1) Develop and execute the global regulatory product strategy
2) Lead GRTs
3) Represent Regulatory on the product team and other key cross-functional teams and commercialization governance bodies
4) Obtain input from the GRT members to develop a global regulatory strategy which supports lifecycle maintenance.
5) Identify and communicate regulatory risks
6) Develop strategies and plans to maintain regulatory approvals and product labeling
7) Provide regulatory direction in the development of the core data sheet in the context of available and expected scientific data, regulatory guidance and precedent
8) Lead the planning and implementation of global regulatory filings (e.g. label extensions, CMC changes)
9) Ensure consistency of evidence-based global product communication (e.g. regulatory submission documents)
10) Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment
11) Ensure guidance on regulatory mechanisms to optimize lifecycle management is assessed and incorporated into the global regulatory strategy
12) Communicate consistently well defined, successful regulatory strategies throughout the organization such that expectation is understood
13) Ensure effective regulatory agency communications by leading core regulatory and cross functional teams (e.g. GRTs, filing teams)
14) Attend key regulatory agency meetings which could impact the global product strategy
15) Represent Amgen Regulatory on external partnership teams at the product level
Basic Qualifications and Experience:
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Doctorate degree and 3 years of regulatory experience in biotech or science Or
Master's degree and 6 years of regulatory experience in biotech or science Or
Bachelor's degree and 8 years of regulatory experience in biotech or science
Soft Skills: - Ability to lead effective teams - Strong communication skills - both oral and written - Ability to understand and communicate scientific/clinical information - Ability to anticipate and mitigate against future issues & uncertainties - Ability to resolve conflicts and develop a course of action - Cultural awareness and sensitivity to achieve global results - Planning and organizing abilities - Able to prioritize and manage multiple activities - Ability to make decisions and solve problems - Ability to deal with ambiguity
**EQUAL OPPORTUNITY STATEMENT**
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.
We will ensure that individuals with disabilities are provided with 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 an accommodation.
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Director Regulatory Affairs

Maharashtra, Maharashtra Michael Page

Posted today

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  • Be part of fastest growing medical AI company success story
  • Be the primary liaison for quality system management and regulatory affairs
  • About Our Client

    Fast growing medical AI company developing cutting edge solutions that enhance patient outcomes.

    Job Description

    Manage regulatory submissions, lead a team, ensure product compliance, and strategically navigate global market entry. Success is measured by achieving and maintaining regulatory excellence, aligning cross-functional teams, and ensuring efficient product approvals.

    The Successful Applicant

    - Deep knowledge of AI regulations, Software as a Medical Device (SaMD), global regulatory frameworks like FDA, EU MDR, cybersecurity, and quality standards.

    - 8-15 years work experience with hands on experience in AI and healthcare regulations

    - Strategic thinking with the ability to align regulatory needs with portfolio opportunities.

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    Director of Regulatory Affairs

    Noida, Uttar Pradesh Vahura

    Posted 17 days ago

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    Job Description

    A leading Chartered Accountancy firm in Noida is seeking a dynamic leader to head its expanding Regulatory Division.


    This role offers the chance to shape strategy, drive growth, and deliver regulatory advisory and compliance solutions to prominent corporate clients across sectors.


    The right professional will bring at least 12 years of post-qualification experience, deep expertise in regulatory services, and strong credentials as a Company Secretary (CS+LLB preferred).


    If you are keen, reach out to and to explore this opportunity.

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    Director of Regulatory Affairs

    Noida, Uttar Pradesh Vahura

    Posted 3 days ago

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    Job Description

    A leading Chartered Accountancy firm in Noida is seeking a dynamic leader to head its expanding Regulatory Division.

    This role offers the chance to shape strategy, drive growth, and deliver regulatory advisory and compliance solutions to prominent corporate clients across sectors.

    The right professional will bring at least 12 years of post-qualification experience, deep expertise in regulatory services, and strong credentials as a Company Secretary (CS+LLB preferred).

    If you are keen, reach out to and to explore this opportunity.

    This advertiser has chosen not to accept applicants from your region.

    Director of Regulatory Affairs

    Noida, Uttar Pradesh Vahura

    Posted today

    Job Viewed

    Tap Again To Close

    Job Description

    A leading Chartered Accountancy firm in Noida is seeking a dynamic leader to head its expanding Regulatory Division.

    This role offers the chance to shape strategy, drive growth, and deliver regulatory advisory and compliance solutions to prominent corporate clients across sectors.

    The right professional will bring at least 12 years of post-qualification experience, deep expertise in regulatory services, and strong credentials as a Company Secretary (CS+LLB preferred).

    If you are keen, reach out to and to explore this opportunity.

    This advertiser has chosen not to accept applicants from your region.

    Director of Regulatory Affairs

    Uttar Pradesh, Uttar Pradesh Vahura

    Posted 16 days ago

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    Job Description

    A leading Chartered Accountancy firm in Noida is seeking a dynamic leader to head its expanding Regulatory Division.


    This role offers the chance to shape strategy, drive growth, and deliver regulatory advisory and compliance solutions to prominent corporate clients across sectors.


    The right professional will bring at least 12 years of post-qualification experience, deep expertise in regulatory services, and strong credentials as a Company Secretary (CS+LLB preferred).


    If you are keen, reach out to and to explore this opportunity.

    This advertiser has chosen not to accept applicants from your region.

    Director of Regulatory Affairs

    Noida, Uttar Pradesh Vahura

    Posted today

    Job Viewed

    Tap Again To Close

    Job Description

    A leading Chartered Accountancy firm in Noida is seeking a dynamic leader to head its expanding Regulatory Division.


    This role offers the chance to shape strategy, drive growth, and deliver regulatory advisory and compliance solutions to prominent corporate clients across sectors.


    The right professional will bring at least 12 years of post-qualification experience, deep expertise in regulatory services, and strong credentials as a Company Secretary (CS+LLB preferred).


    If you are keen, reach out to and to explore this opportunity.

    This advertiser has chosen not to accept applicants from your region.
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    Legal & Compliance

    Mumbai, Maharashtra Serving Skill

    Posted today

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    Job Description

    Negotiation, Drafting and Vetting of various legal agreements such as non-disclosure

    agreement, Service Agreement, Distribution Agreement, IT Agreement, Marketing

    Agreement etc.
    - To draft and execute Leave and License Agreement.
    - To provide legal opinion to internal department viz, underwriters, claims, complaints

    etc.

    **Job Types**: Full-time, Permanent

    Pay: ₹500,000.00 - ₹700,000.00 per year

    Schedule:

    - Monday to Friday

    **Education**:

    - Bachelor's (preferred)

    **Experience**:

    - General Insurance: 1 year (preferred)
    - Legal & compliance: 1 year (preferred)
    - Drafting: 1 year (preferred)
    - Vetting: 1 year (preferred)

    Work Location: In person
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    Manager - Legal Compliance

    Pune, Maharashtra Mastercard

    Posted 4 days ago

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    Job Description

    **Our Purpose**
    _Mastercard powers economies and empowers people in 200+ countries and territories worldwide. Together with our customers, we're helping build a sustainable economy where everyone can prosper. We support a wide range of digital payments choices, making transactions secure, simple, smart and accessible. Our technology and innovation, partnerships and networks combine to deliver a unique set of products and services that help people, businesses and governments realize their greatest potential._
    **Title and Summary**
    Manager - Legal Compliance
    Global Compliance & Ethics team provides expert compliance leadership to the organization. The Anti-Corruption team within Global Compliance has built a robust testing and monitoring program that allows the team to communicate how well Mastercard offices are performing against Mastercard standards and regulatory requirements. The Monitoring and Testing team supports Global Compliance & Ethics in meeting compliance obligations.
    Reporting to the Director, the Manager will be a part of the M&T team and support Global/EEMEA Compliance & Business by 1) performing tests of Compliance control effectiveness 2) following up on testing results and 3) creating summarized reporting of results for sharing with Mastercard stakeholders. 4) Develop metrics and reports for senior management
    - Do you have experience performing detailed testing to ensure policies and procedures are being followed?
    - Do you have a curious mind that will lead you to investigate to understand the root cause of issues uncovered in testing?
    - Do you enjoy building informative reporting to help business owners manage their business?
    Role
    - Serves as the go-to person in the resolution of routine issues/tasks within a compliance area, typically escalates or seeks advice on non-standard/complex issues.
    - Provides measurable input into creating compliance programs or policies and supports execution of programs or projects with a focus on EEMEA Region.
    - Investigates and escalates potential compliance risks to minimize adverse financial impact and lawful liability
    - Tracks ongoing measurement and monitoring of compliance program efforts and controls, including compiling data or metrics for reporting
    - Perform detailed tests of Compliance controls for EEMEA/Global based on documented testing steps to ensure Mastercard employee comply with policies, procedures, laws, and regulations
    - Apply critical thinking to interpret data and documentation to determine whether it adequately meets the policy and regulatory requirements, including documenting the rationale behind the decisions
    - Summarize test results and data sets and incorporate results them into informative management reporting for the EEMEA Regional Business
    - Collaborate with internal business partners to identify problem solving solutions to challenges in executing testing program
    -
    All About You
    - Experience in performing control tests - particularly in an audit capacity
    - CA, CFE, CIA and/or Relevant Compliance Certifications also considered
    - Strong business acumen, analytical, and problem-solving skills - particularly resourcefulness in identifying solutions to problems
    - Banking or card payment experience a plus.
    - Familiarity with United States Foreign Corrupt Practices Act (FCPA) and the UK Bribery Act (UKBA) and local laws
    - Self-starter who is flexible and solutions-oriented, and able to work in a team-based environment.
    - Ability to summarize data into meaningful results and reports used to drive the business
    - Strong Microsoft Office skills especially (MS Excel, PowerPoint) required
    - Experience in handling tools like Power BI, Alteryx and Tableau, build and maintain workflows
    - Fluency in English, and additional languages preferred.
    - Ability to juggle substantial competing demands and adapt to evolving priorities a must.
    - Strong written and verbal communication skills.
    - Attention to detail is critical.
    **Corporate Security Responsibility**
    All activities involving access to Mastercard assets, information, and networks comes with an inherent risk to the organization and, therefore, it is expected that every person working for, or on behalf of, Mastercard is responsible for information security and must:
    + Abide by Mastercard's security policies and practices;
    + Ensure the confidentiality and integrity of the information being accessed;
    + Report any suspected information security violation or breach, and
    + Complete all periodic mandatory security trainings in accordance with Mastercard's guidelines.
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