About the role

Aplyr's Quick Take

This role is for a Regulatory Affairs Manager who oversees product registration submissions and interacts with regulatory agencies to ensure timely approvals. You'll be involved in regulatory strategy, risk management, and advising teams on compliance throughout the product lifecycle. It's a managerial position that requires strong communication and collaboration skills.

Good fit

Ideal candidates have several years of experience in regulatory affairs, particularly in pharmaceuticals or medical devices. A background in legal or political frameworks and a collaborative working style will help you thrive here.

Worth noting

The role involves significant interaction with regulatory bodies and may require public representation in industry forums, which could be a unique opportunity for those interested in policy advocacy. The job spec lacks detail on daily tasks and travel requirements.

JOB DESCRIPTION:

List the main responsibilities this role regularly performs.

- As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
- Interacts with regulatory agency to expedite approval of pending registration.
- Serves as regulatory liaison throughout product lifecycle.
- Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
- Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
- Serves as regulatory representative to marketing, research teams and regulatory agencies.
- Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.

For example you may consider to add :

Policy Tracking: Monitor new or changing laws, regulatory frameworks, and government proposals.
Impact Analysis: Assess how regulatory shifts affect business operations, products, or company assets.
Position Development: Draft official policy interpretations, corporate stances, and defense strategies for regulators.
External Representation: Speak for the organization in industry associations, trade groups, and public policy forums.

Required Skills

Legal and Political Acumen: Strong understanding of how legislative bodies and regulatory agencies operate.
Communication: Ability to translate dense legal text into clear, persuasive briefs for executives and external agencies.
Skill in collaborating with cross-functional teams and external stakeholders.

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Regulatory Operations

DIVISION:

EPD Established Pharma

LOCATION:

India > Mumbai : BKC Building

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Keyboard use (greater or equal to 50% of the workday)

Skills & Tags

Aplyr's read

Abbott Laboratories is a leader in healthcare innovation, attracting professionals dedicated to advancing medical technology and patient care on a global scale.
Synthesized from recent postings & public sources

What's promising

•Abbott's diverse product range offers stability and growth opportunities.
•Strong global presence enhances career mobility and international experience.
•Commitment to R&D fosters a culture of innovation and learning.

What to watch

•Regulatory challenges can impact product launch timelines.
•High competition in the healthcare sector pressures market share.
•Complex organizational structure may slow decision-making processes.

Why Abbott

•Abbott's focus on both diagnostics and nutrition sets it apart from typical pharmaceutical companies.
•Extensive global footprint provides unique cross-border project opportunities.
•Abbott's investment in emerging markets offers growth in diverse regions.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Abbott

Abbott

abbott.com

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Abbott Laboratories is a global healthcare company that develops and manufactures a wide range of medical devices, diagnostics, nutrition products, and branded generic pharmaceuticals.